Category: Family

Insulin pump therapy inclusiveness

Insulin pump therapy inclusiveness

is includiveness advisory board member of MSD, AstraZeneca, Roche Diabetes Care, and Abbott. Allgemeine Depressions-Skala [German Version of the Center for Epidemiologic Studies Depression Scale - CES-D]. Home PDMarshall SM Problems and safety of continuous subcutaneous insulin infusion. Insulin pump therapy inclusiveness

Insulin pump therapy inclusiveness -

Our study was thus designed to determine rates and patterns of insulin pump and CGM device use among Spanish-language—preferring Hispanic children with T1D receiving care at an academic medical center and to further identify specific barriers to technology use in these children.

A recent study [ 9 ] has shown differences in technology use between Spanish-speaking and English-speaking Latinx families, with significant differences found in technology use and attitudes about diabetes technology between the 2 language groups. Our study, therefore, builds upon what is currently known about differences in care outcomes among children with T1D by examining specific experiences and potential barriers to diabetes technology use among Spanish-language—preferring patients with T1D compared to their White peers.

Study approval was provided by the UC Davis Institutional Review Board assessing rates and patterns: ; assessing barriers: , and consent requirements were waived for this portion of the study.

All of the Spanish-language—preferring children seen in our practice who met the inclusion and exclusion criteria were included in the study. The same inclusion and exclusion criteria were used for the non-Hispanic White participants, except for primary language which was required to be English.

From among the pool of eligible non-Hispanic White patients, participants were selected via random matching to the Spanish-language—preferring participants based on current age and diabetes duration using a computer algorithm.

Families were not compensated for participation in this portion of the study, which only involved medical record review. Data on technology use were collected, including if the child had ever used an insulin pump or CGM device, if the child was currently using an insulin pump or CGM device, and the dates the insulin pump or CGM device were used.

Participant selection and data abstraction were both performed in We then compared the rates of technology use eg, insulin pump and CGM device , the average length of time between diabetes diagnosis and initiation of technology use, and the rates of device discontinuation between the Spanish-language—preferring and non-Hispanic White groups.

We initially compared data for Spanish-language—preferring participants to the data of non-Hispanic White participants using 2-tailed student t test for continuous variables and chi-square test for categorical variables.

We then used logistic regression analyses to determine whether differences in technology use persisted after adjusting for the effects of other covariates, such as sex and type of health insurance. Second, to better understand specific barriers to technology use, all Spanish-language—preferring participants and their families identified from the previous cohort were asked to complete a written questionnaire detailing their decision-making surrounding technology use.

The questionnaire contained items pertaining to both pump and CGM use; however, as Spanish language preference was not predictive of CGM use in the first portion of the study, we did not conduct further analyses on survey responses related to CGM use. Questions and response options included in the questionnaire can be accessed in Table S1 in Multimedia Appendix 1.

Participants for this portion of the study were enrolled by the study personnel during outpatient diabetes visits over a 6-month period in To gather comparable perspectives about insulin pump nonuse by non-Hispanic White patients, we identified a cohort of non-Hispanic White patients who met our initial inclusion criteria but were not using insulin pumps.

These participants were again matched to our Spanish-language—preferring cohort based on age and diabetes duration. Non-Hispanic White control participants were enrolled at the time of a regularly scheduled clinic visit, similar to our Spanish-language—preferring participants, and completed the same written questionnaire about diabetes technology decision-making during the same study period.

All non-Hispanic White control participants completed the questionnaire in English. The non-Hispanic White survey group was selected for pump nonuse to capture an adequate sample of pump nonusers from among an ethnic cohort with a majority using the pump ; therefore, the non-Hispanic White sample was larger than the Spanish-language—preferring sample for this part of the analysis.

We did not select for insulin pump never-use to allow for analysis of rates of pump discontinuation. Questionnaire responses in the Spanish-language—preferring and non-Hispanic White groups were compared using Fisher exact test.

A total of 43 children with T1D aged years with Hispanic ethnicity and Spanish-language preference, who were listed in the electronic medical record, were initially identified and had their primary language confirmed by the study personnel.

Of these, 2 failed to meet all inclusion criteria, and 3 lacked information in their medical records necessary for accurate data retrieval. Thus, 38 Spanish-language—preferring children were included for analyses assessing rates of technology use.

In addition, non-Hispanic White children were identified as potential controls, and 38 of them were matched to the Spanish-language—preferring participants via an Microsoft Excel-based computerized formula using date of birth and date of diabetes diagnosis.

Demographic characteristics of the study groups are shown in Table 1. Among families using pumps, the Spanish-language—preferring participants started use at approximately the same time after diagnosis as the non-Hispanic White participants CGM device use began later in Spanish-language—preferring participants In multivariable analyses, ethnicity or language group and diabetes duration continued to be significant predictors of insulin pump use, after adjusting for age, gender, age at diagnosis, and type of insurance Table 2.

In regard to CGM device use, ethnicity was no longer predictive of device use after adjusting for age, gender, age at diagnosis, and type of insurance. Analyses of barriers to technology use therefore focused on participants who were not using insulin pumps, and we did not conduct further analyses pertaining to CGM use.

Of the 38 Spanish-language—preferring families identified through medical record review, 30 were seen in clinic during the 6-month study period and completed the questionnaire assessing barriers to technology use.

These 30 participants were then matched to a group of 30 non-Hispanic White pump nonusers based on age and diabetes duration Table 3. Of the Spanish-language—preferring participants, 19 were current pump nonusers, and 13 had never previously used an insulin pump.

To avoid having prior pump users reporting on decision-making about pump use, only the participants who had never used a pump were included in these analyses. Although the non-Hispanic White control participants were selected based on current insulin pump nonuse not insulin pump never-use , none had ever previously used a pump.

There were not differences seen between the 2 groups with regard to primary reason s for pump nonuse, such as lack of perceived need or fear of error Table 5. Recent literature has highlighted racial and ethnic disparities in both glycemic outcomes and diabetes technology use among children with T1D [ 3 - 10 ].

Common barriers to pump therapy adoption in pediatric patients include concerns about having a device attached to the body, therapeutic effectiveness compared to insulin injection regimens, and cost burden [ 11 - 13 ].

Additional barriers faced by historically marginalized racial and ethnic groups can include difficulties with access to care, provider bias, and socioeconomic disparities [ 14 - 16 ].

The specific effect of a language barrier on diabetes technology use is uncertain in the existing pediatric literature, and preliminary data [ 9 ] suggest technology use and attitudes may vary among Spanish-speaking versus English-speaking Hispanic patients and families.

Our study was designed to explore specific experiences and potential barriers to diabetes technology use among Spanish-language—preferring patients with T1D. Our results are consistent with the existing literature in that we found lower rates of insulin pump use in Spanish-language—preferring children compared to non-Hispanic White controls.

This finding held true even after adjusting for age, sex, diabetes duration, and type of insurance. However, we did not find that ethnicity was a significant predictor of CGM device use after adjustment for health insurance type, which was strongly associated with CGM device use in our study population.

Differences in access to CGM device based on health insurance may therefore have obscured differences related to ethnicity within our cohort.

Of note, our clinic protocol for CGM initiation was relatively straightforward compared to the protocol for insulin pump initiation at the time of this study. For pump initiation, our patients were required to attend a pre—pump use class during which they learned about insulin pump therapy and various device options and complete a pre—pump use checklist, which included a skills assessment on various aspects of diabetes management.

It is possible that the process for pump initiation presented additional barriers to our Spanish-language—preferring patients and that this contributed to the differences seen between pump and CGM use in our clinic. In other settings, provider bias has been widely identified as a contributing factor to racial and ethnic disparities in health outcomes [ 17 , 18 ].

However, our questionnaire did not assess the content of these clinician discussions, which may have influenced whether Spanish-language—preferring participants felt adequately educated and encouraged about technology use.

The fact that our Spanish-language—preferring families felt less confident that they could learn to use a pump suggests that additional education from their health care teams may be needed to prepare them for successful technology use. In sum, our findings suggest that further work is needed to better understand how to best support diabetes technology use among the Spanish-language—preferring community.

Improved Spanish language teaching materials and in-person Spanish instructions are likely needed as well as increased contact with peer groups using diabetes technology, to reduce the observed disparities in insulin pump use between Spanish-language—preferring patients and their non-Hispanic White peers.

In addition, our novel finding that Spanish-language—preferring children are more likely to discontinue insulin pump use after starting it highlights the need for improved support after initiation of pump therapy. Shared medical appointments that include group education have been associated with increased technology adoption among Spanish-language—preferring children and adolescents [ 19 ], but additional studies are needed to determine how to best maintain insulin pump and CGM device use in these patients and families.

A strength of our study was the relatively high study completion rates for eligible participants, minimizing issues with sampling bias. However, the study also has several limitations. First, the study sample was small due to the single center analysis, and generalizability is limited by possible variations in clinical practice and patterns of insurance coverage.

In addition, we did not collect information on socioeconomic status beyond insurance type, and this could be an important variable to consider in future studies, as Spanish-speaking populations may vary culturally and socioeconomically between locations.

A larger sample size or alternate study format eg, focus groups might allow for additional analyses not conducted in our sample, such as a detailed investigation of reasons why children discontinued insulin pump use.

A larger sample size would also be necessary to compare decision-making among Hispanic Spanish-language—preferring families versus Hispanic English-language—preferring families [ 9 ]. Additionally, it is possible that our questionnaire failed to capture some barriers to technology use in this patient population.

We employed an experienced multidisciplinary diabetes team including members with Spanish-language fluency and extensive experience working with the Spanish-speaking population to collaborate in questionnaire design, but the questionnaire was not previously studied or validated for this clinical question and target population, so this remains a limitation.

Finally, the study was conducted before the COVID pandemic, and diabetes technology use has changed in several ways since the data were collected.

In particular, CGM device use has increased substantially in our patient population due to expanded insurance coverage, particularly among those with public insurance. In addition, several new integrated pump-CGM systems providing automated insulin delivery have been released since our study concluded, and questions of access, use, and comfort with these new systems among Spanish-language—preferring children is an important area for future inquiry.

This study confirms that Spanish-language preference is associated with lower rates of insulin pump use in children with T1D, even after controlling for age, gender, age at diagnosis, and type of insurance.

In addition, our analysis suggests that Spanish-language—preferring families experience higher rates of insulin pump discontinuation than their English-speaking non-Hispanic White counterparts.

This improved HbA 1c remained significant throughout the 7 years of follow-up. Pump therapy reduced severe hypoglycaemia from In contrast, severe hypoglycaemia increased in the non-pump cohort over the same period from 6.

The rate of hospitalisation for DKA was lower in the pump cohort 2. This is the longest and largest study of insulin pump use in children and demonstrates that pump therapy provides a sustained improvement in glycaemic control, and reductions of severe hypoglycaemia and hospitalisation for DKA compared with a matched cohort using injections.

Melanie J. Davies, Vanita R. Aroda, … John B. Richard I. Holt, J. Hans DeVries, … Anne L. Davies, David A. The increasing use of insulin pump therapy over the last 15 years, particularly in children, has been driven by improvements in pump technology and the availability of insulin analogues, along with the results of the Diabetes Control and Complications Trial DCCT , which established the benefit of improved glycaemic control [ 1 , 2 ].

Despite this increased use, the outcomes of pump therapy continue to be debated. Most studies report an improvement in HbA 1c associated with pump therapy [ 3 — 5 ], although some report no improvement or an initial improvement followed by a return to pre-pump levels after a short time [ 6 — 9 ].

Reports have also suggested that insulin pumps may be associated with a reduction in severe hypoglycaemia [ 3 , 10 , 11 ]. Most studies, however, have been of short duration; very few with greater than 4 years of follow-up.

Thus, and particularly in children, there are few studies investigating the long-term impact of insulin pump therapy. Princess Margaret Hospital PMH is the only paediatric referral centre for diabetes servicing the entire state of Western Australia.

This enables analysis of a population-based cohort. Data are collected prospectively at each visit and entered into the Western Australian Childhood Diabetes Database WACDD.

Pump therapy was introduced at our centre in We have previously reported on the first patients who commenced pump therapy at our institution [ 3 ].

Over the 2 year follow-up presented in that study, patients on pump therapy had a reduction in HbA 1c of 0. There were also improvements in components of the Diabetes Quality of Life assessment. A limitation of this study, as with most other reports, was the short period of follow-up.

In addition, the first patients to commence pump therapy in our centre may have been subject to some selection bias. This current report takes advantage of access to a large population-based sample and aims to determine the long-term impact of insulin pump therapy on diabetes outcomes over a 7 year period.

Using a case—control design, we matched patients already commenced on insulin pump therapy with patients on injection therapy. Only patients who commenced insulin pump therapy at least 6 months after diagnosis and with a minimum of 6 months of data on their pump therapy were included in the analysis.

Patients on insulin pump therapy were matched to patients on injection therapy on the basis of age within 1 year , duration of diabetes within 2 years and HbA 1c at the time of pump start within 1.

Patients on injection therapy were further subdivided into those on a basal bolus regimen of multiple daily injections MDI or those on injections twice daily BD or injections three times daily TDS according to their therapy at the time their matched pump patient began insulin pump therapy.

As this is an observational study where the source of data is a paediatric clinical database, the data are subject to natural attrition. For example, patient data collection ceases when a patient leaves the state or upon transition to an adult clinic at approximately age 18 years or at the end of the study period January Data are only displayed at each time-point when available for both pump and non-pump match; the longest period of paired data available was 7 years.

Matching was performed using a custom random-sampling matching algorithm implemented in R 2. org [ 13 ], which minimised the mean difference in HbA 1c at the time of pump start across all participants in the study. Clinical data were obtained from the WACDD.

Fields extracted from the WACDD included patient height and weight, episodes of hypoglycaemia, HbA 1c , insulin dose, episodes of diabetic ketoacidosis DKA and demographic details. Severe hypoglycaemia was defined as an event resulting in coma or convulsion.

All children have HbA 1c measured in clinic every 3 months by agglutination inhibition immunoassay Ames DCA ; Bayer, Mishawaka, IN, USA , calibrated to DCCT-equivalent numbers. HbA 1c was also taken at the time of pump start. HbA 1c values closest to each specified time-point were used.

For those who did not have an appointment during this time, the value was taken as the average of the HbA 1c measurements before and after the date, within 3 months of the date of pump start. Prior to commencing pump therapy all patients are assessed by the multidisciplinary team for suitability for pump therapy.

Insulin pumps are funded through private health insurance or, if not available, by donation. The cost of the consumables is subsidised by the Australian government National Diabetes Supply Scheme. Initially all pump starts were performed in an inpatient set-up, during which time patients had glucose monitoring and further education.

Patients were then followed with daily telephone calls for a week following discharge and were seen in the clinic again within a fortnight. From we moved to a day-only admission for pump starts. The patient and family undergo outpatient education with the dietitian and educators prior to commencing pump therapy.

They then have access to daily phone contact with the educators for therapy adjustment. Statistics were analysed using SPSS for Windows Version BMI standard deviation scores z scores were obtained using the Epi Info Version 7.

Data are presented as mean ± SD. Change in HbA 1c was analysed using a paired t test of the difference in HbA 1c between the pump and matched non-pump groups i. Differences in DKA and hypoglycaemia rates were analysed using a χ 2 test.

Altogether, patients attending PMH Diabetes Clinics from January to January used insulin pump therapy. Data from 98 patients were excluded from the analysis as they did not meet the inclusion criteria. Thus 45 patients commenced pump therapy within 6 months of diagnosis, 43 had less than 6 months of data since starting pump therapy and ten began pump therapy at another centre.

Of the eligible patients, matches within the defined thresholds were available for By design, the pump and non-pump cohorts were well matched for baseline characteristics Table 1 , with no significant difference in age at pump start This reflects the sex distribution among clinic patients as a whole.

At the time of pump start, there was no difference between the pump and non-pump cohorts for HbA 1c 8. In the year prior to commencing pump therapy, the pump group had a higher rate of severe hypoglycaemia than the non-pump cohort Patients on injection therapy at our clinic comprise those on BD, TDS or MDI.

Insulin glargine A21Gly,B31Arg,B32Arg human insulin was introduced at our practice in , replacing NPH insulin as the long-acting insulin for the MDI group and resulting in wider use of the MDI regimen. There was no significant difference for age at pump start in the pump vs MDI sub-cohort Of the patients on pump therapy, 38 ceased pump therapy during the course of the study; six of these were in the 1st year of treatment, seven in the 2nd year and ten in the 3rd year, while the remainder had had at least 3 consecutive years on pump therapy before discontinuing.

Figure 1 shows the mean HbA 1c for the pump and non-pump cohorts over the 7 years of follow-up, shown 3-monthly until 12 months, 6-monthly until 2 years and yearly thereafter. Figure 1a compares all patients on injection therapy with their matched pump patient. Both groups had a similar HbA 1c at the time of pump start.

The mean difference in HbA 1c between the pump and non-pump cohort was 0. Once on insulin pump therapy, the pump cohort had a significantly improved HbA 1c at all time-points inclusive through to the final 7 year follow-up comparison, with an initial rapid improvement in the pump vs non-pump groups of 0.

The level of improvement was lowest at 2 years, although still significant at 0. The improvement in the pump cohort increased from years 2 to 7, reaching a maximum of 1.

In absolute terms the lowest HbA 1c in the pump cohort was achieved at 3 months at 7. In the injection cohort, however, the mean HbA 1c continued to increase over time from 8. Follow-up was limited to 5 years as group size thereafter was fewer than five.

When compared with MDI therapy Fig. The mean improvement in HbA 1c over the 5 years was 0. This difference peaked at 5 years when the difference in HbA 1c was 1.

The analysis and data presentation comparing pump and MDI patients were limited to 5 years, as in subsequent years less than five matched pairs were available. The mean difference over this time was 0.

The rate of severe hypoglycaemia was higher in the pump group prior to commencing insulin pump therapy After starting pump therapy, the rate of hypoglycaemia decreased in the pump cohort to half of that in the year before pump therapy Severe hypoglycaemia increased in the non-pump cohort over the same period from 6.

The rate of hospitalisation for DKA was the same for the two groups prior to pump therapy. However, the rate of hospitalisation for DKA increased in the non-pump cohort pre-pump 1. Thus over the 1, patient-years of follow-up, the hospitalisation rate for DKA for those on continuous subcutaneous insulin infusion CSII was half that of those using injections 2.

There was no significant difference in BMI z score for those on pump or injection regimens at baseline or over the follow-up period. As shown in Fig. Patients with an HbA 1c of 7. a—c Values are presented according to the HbA 1c value at time of pump start, i.

d—f Values are presented according to age at time of pump start, i. Over the following 5 years, each age group on the pump showed an improvement compared with non-pump counterparts. This is the largest study of insulin pump use in children.

It also has the longest follow-up period of any study of insulin pump therapy in children. Our data confirm that insulin pump therapy improves glycaemic control, with improvements being sustained for at least 7 years. The mean improvement in HbA 1c of 0. The reduction in HbA 1c in CSII compared with MDI groups in our study was consistent with other studies, with a mean improvement of 0.

A meta-analysis of paediatric and adult studies by Pickup revealed a 0. This analysis included observational studies, as well as randomised controlled trials RCTs. A meta-analysis of RCTs alone revealed a mean HbA 1c improvement of 0. There are very few RCTs of CSII versus MDI in children, and all are of less than 12 months duration [ 5 — 7 , 17 ].

The initial immediate reduction in HbA 1c has been well described in previous observational studies and some RCTs [ 3 , 8 , 11 , 18 , 19 ]. Prior to commencing pump therapy, all patients at our institution are assessed by our treating team for suitability for insulin pump therapy.

All families undergo extensive further education and glucose monitoring with diabetes educators and dietitians. The increased education and educator contact may be responsible for some of the early improvement in HbA 1c , as studies have confirmed that increased contact with diabetes educators between medical appointments can improve diabetes control [ 20 ].

The novelty of this new technology may also increase patient motivation to manage their diabetes in the short term. Following the initial improvement, HbA 1c in the pump patients increased at 2 years. However, it remained 0. Sulli and Shashaj also noted a trend for the mean HbA 1c to increase at 2 years before improving for the next 2 years of their study [ 4 ].

This may be partly due to waning enthusiasm for the new technology. The former cohort was older and attention to blood glucose control may be less pronounced in older adolescents, who also have more autonomy in their diabetes management.

From years 2 to 7 the mean HbA 1c in the pump group showed a further trend towards improvement. However, the group using injection therapy displayed a steady increase in HbA 1c over the 7 years of follow-up at a rate of 0.

As the mean age at pump start was As such, the difference between the pump and injection cohorts generally becomes greater as time on pump therapy increases. By using matched patients for this analysis, we were able to take into account the natural increase in HbA 1c observed over time in this cohort.

No RCTs in children that examined this difference over time lasted longer than 12 months. There is a perception that children with poorer glycaemic control will not benefit from insulin pump therapy. Indeed, patients with poor control are often excluded from trials of insulin pump therapy.

However, a number of RCTs and observational studies have revealed that this group frequently has the greatest improvement in glycaemic control with pump therapy [ 17 , 23 , 24 ]. These patients, moreover, are at greatest risk of developing complications and stand to benefit most from a reduction in HbA 1c [ 2 ].

This result was also sustained for at least 4 years of follow-up after which the numbers fail to reach significance. Importantly, this improvement was not achieved as a result of deteriorating glycaemic control in the non-pump cohort, which remained static.

In the year prior to starting pump therapy, our patients had double the rate of severe hypoglycaemia. Severe hypoglycaemia, fear of hypoglycaemia or recurrent hypoglycaemia are often reasons for considering insulin pump therapy. Hypoglycaemia is one of the main limiting factors to obtaining optimal metabolic control.

In addition, fear of hypoglycaemia can significantly impair the quality of life of the child and its parents [ 25 ]. Previous studies have shown a significant improvement in quality of life upon starting insulin pump therapy, in particular with respect to worrying about hypoglycaemia [ 26 ].

It is pleasing to see that the improvement in HbA 1c was achieved together with a reduction in the rate of severe hypoglycaemia.

Other studies in this field have revealed conflicting results. A meta-analysis of RCTs of CSII vs MDI revealed no significant difference in the rate of severe hypoglycaemia [ 16 ]. This may be due to the low baseline rate of hypoglycaemia in those participants, combined with a relatively short follow-up period.

This paper included RCTs and observational studies, the latter of which comprise the majority of long-term studies in this area. Their results are more consistent with those of our case—control observational study.

There are fewer studies in children on this issue. Again, the available RCTs have not shown a significant reduction in the rate of hypoglycaemia [ 6 , 17 ], while observational studies have suggested that CSII does indeed decrease the frequency of severe hypoglycaemia [ 3 , 27 ].

A study of hypoglycaemia in the last 10 years at our institution revealed a lack of association between rates of severe hypoglycaemia and HbA 1c in clinic patients as a whole [ 28 ]. There was no significant BMI change in our CSII cohort.

However, the mean BMI z score of both groups was above the 50 th centile for age, consistent with other studies on weight and diabetes [ 29 ]. CSII allows greater flexibility with regard to the number and carbohydrate content of meals. One concern is that this greater freedom may cause some patients to take advantage of this situation and consume more food, especially at the start of pump therapy.

However, we did not see a significant change in BMI z score at any time-point. CSII can also allow patients to have more control over their eating patterns; they may not be required to eat as many meals or snacks to match the less physiological insulin delivery provided by injection therapy.

Patients on insulin pump therapy have a potential risk of line disconnection or pump malfunction with subsequent DKA.

DKA is a preventable complication if blood glucose levels and ketones are frequently monitored. Prior to commencing insulin pump therapy, patients and their families undergo further education and liaise closely with diabetes educators. A key requirement for potential insulin pump therapy users is sufficient motivation and the ability and willingness to test blood glucose levels four times a day.

The decreased rate of DKA may be a result of increased education or the increased motivation of patients and families. The non-pump cohort had a significantly increased rate of DKA over the follow-up period.

An increase in DKA during adolescence is common [ 30 ]. This was an observational trial following patients within our clinic. We therefore lack follow-up data for patients after this age. The small numbers of patients remaining after 5 years are those who began pump therapy at least 5 years previously and at an age sufficiently young for them to still be in our clinic 5 years later.

The introduction of insulin glargine A21Gly,B31Arg,B32Arg human insulin into clinical practice in saw an increase in the use of MDI. In our clinical practice, MDI is more commonly used in adolescent patients as opposed to younger children.

The combination of older participants and more recent use of MDI resulted in fewer years of follow-up for the MDI vs pump cohort.

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Questions and response options included in the questionnaire Insulin pump therapy inclusiveness be accessed in Ihclusiveness S1 in Multimedia Hydration and immune function in youth athletes 1. Participants for this portion Insuin the study were enrolled by the study personnel during outpatient diabetes visits over a 6-month period in To gather comparable perspectives about insulin pump nonuse by non-Hispanic White patients, we identified a cohort of non-Hispanic White patients who met our initial inclusion criteria but were not using insulin pumps.

These participants were again matched to our Spanish-language—preferring cohort based on age and diabetes duration. Non-Hispanic White control participants were enrolled at the time of a regularly scheduled clinic visit, similar to our Spanish-language—preferring participants, and completed the same written questionnaire about diabetes technology decision-making during the same study period.

All non-Hispanic White control participants completed the questionnaire in English. The non-Hispanic White survey group was selected for pump nonuse to capture an adequate sample of pump nonusers from among an ethnic cohort with a majority using the pump ; therefore, the non-Hispanic White sample was larger than the Spanish-language—preferring sample for this part of the analysis.

We did not select for insulin pump never-use to allow for analysis of rates of pump discontinuation. Questionnaire responses in the Spanish-language—preferring and non-Hispanic White groups were compared using Fisher exact test. A total of 43 children with T1D aged years with Hispanic ethnicity and Spanish-language preference, who were listed in the electronic medical record, were initially identified and had their primary language confirmed by the study personnel.

Of these, 2 failed to meet all inclusion criteria, and 3 lacked information in their medical records necessary for accurate data retrieval. Thus, 38 Spanish-language—preferring children were included for analyses assessing rates of technology use. In addition, non-Hispanic White children were identified as potential controls, and 38 of them were matched to the Spanish-language—preferring participants via an Microsoft Excel-based computerized formula using date of birth and date of diabetes diagnosis.

Demographic characteristics of the study groups are shown in Table 1. Among families using pumps, the Spanish-language—preferring participants started use at approximately the same time after diagnosis as the non-Hispanic White participants CGM device use began later in Spanish-language—preferring participants In multivariable analyses, ethnicity or language group and diabetes duration continued to be significant predictors of insulin pump use, after adjusting for age, gender, age at diagnosis, and type of insurance Table 2.

In regard to CGM device use, ethnicity was no longer predictive of device use after adjusting for age, gender, age at diagnosis, and type of insurance. Analyses of barriers to technology use therefore focused on participants who were not using insulin pumps, and we did not conduct further analyses pertaining to CGM use.

Of the 38 Spanish-language—preferring families identified through medical record review, 30 were seen in clinic during the 6-month study period and completed the questionnaire assessing barriers to technology use.

These 30 participants were then matched to a group of 30 non-Hispanic White pump nonusers based on age and diabetes duration Table 3. Of the Spanish-language—preferring participants, 19 were current pump nonusers, and 13 had never previously used an insulin pump.

To avoid having prior pump users reporting on decision-making about pump use, only the participants who had never used a pump were included in these analyses. Although the non-Hispanic White control participants were selected based on current insulin pump nonuse not insulin pump never-usenone had ever previously used a pump.

There were not differences seen between the 2 groups with regard to primary reason s for pump nonuse, such as lack of perceived need or fear of error Table 5. Recent literature has highlighted racial and ethnic disparities in both glycemic outcomes and diabetes technology use among children with T1D [ 3 - 10 ].

Common barriers to pump therapy adoption in pediatric patients include concerns about having a device attached to the body, therapeutic effectiveness compared to insulin injection regimens, and cost burden [ 11 - 13 ]. Additional barriers faced by historically marginalized racial and ethnic groups can include difficulties with access to care, provider bias, and socioeconomic disparities [ 14 - 16 ].

The specific effect of a language barrier on diabetes technology use is uncertain in the existing pediatric literature, and preliminary data [ 9 ] suggest technology use and attitudes may vary among Spanish-speaking versus English-speaking Hispanic patients and families. Our study was designed to explore specific experiences and potential barriers to diabetes technology use among Spanish-language—preferring patients with T1D.

Our results are consistent with the existing literature in that we found lower rates of insulin pump use in Spanish-language—preferring children compared to non-Hispanic White controls.

This finding held true even after adjusting for age, sex, diabetes duration, and type of insurance. However, we did not find that ethnicity was a significant predictor of CGM device use after adjustment for health insurance type, which was strongly associated with CGM device use in our study population.

Differences in access to CGM device based on health insurance may therefore have obscured differences related to ethnicity within our cohort. Of note, our clinic protocol for CGM initiation was relatively straightforward compared to the protocol for insulin pump initiation at the time of this study.

For pump initiation, our patients were required to attend a pre—pump use class during which they learned about insulin pump therapy and various device options and complete a pre—pump use checklist, which included a skills assessment on various aspects of diabetes management.

It is possible that the process for pump initiation presented additional barriers to our Spanish-language—preferring patients and that this contributed to the differences seen between pump and CGM use in our clinic.

In other settings, provider bias has been widely identified as a contributing factor to racial and ethnic disparities in health outcomes [ 1718 ]. However, our questionnaire did not assess the content of these clinician discussions, which may have influenced whether Spanish-language—preferring participants felt adequately educated and encouraged about technology use.

The fact that our Spanish-language—preferring families felt less confident that they could learn to use a pump suggests that additional education from their health care teams may be needed to prepare them for successful technology use.

In sum, our findings suggest that further work is needed to better understand how to best support diabetes technology use among the Spanish-language—preferring community.

Improved Spanish language teaching materials and in-person Spanish instructions are likely needed as well as increased contact with peer groups using diabetes technology, to reduce the observed disparities in insulin pump use between Spanish-language—preferring patients and their non-Hispanic White peers.

In addition, our novel finding that Spanish-language—preferring children are more likely to discontinue insulin pump use after starting it highlights the need for improved support after initiation of pump therapy.

Shared medical appointments that include group education have been associated with increased technology adoption among Spanish-language—preferring children and adolescents [ 19 ], but additional studies are needed to determine how to best maintain insulin pump and CGM device use in these patients and families.

A strength of our study was the relatively high study completion rates for eligible participants, minimizing issues with sampling bias. However, the study also has several limitations. First, the study sample was small due to the single center analysis, and generalizability is limited by possible variations in clinical practice and patterns of insurance coverage.

In addition, we did not collect information on socioeconomic status beyond insurance type, and this could be an important variable to consider in future studies, as Spanish-speaking populations may vary culturally and socioeconomically between locations.

A larger sample size or alternate study format eg, focus groups might allow for additional analyses not conducted in our sample, such as a detailed investigation of reasons why children discontinued insulin pump use. A larger sample size would also be necessary to compare decision-making among Hispanic Spanish-language—preferring families versus Hispanic English-language—preferring families [ 9 ].

Additionally, it is possible that our questionnaire failed to capture some barriers to technology use in this patient population. We employed an experienced multidisciplinary diabetes team including members with Spanish-language fluency and extensive experience working with the Spanish-speaking population to collaborate in questionnaire design, but the questionnaire was not previously studied or validated for this clinical question and target population, so this remains a limitation.

Finally, the study was conducted before the COVID pandemic, and diabetes technology use has changed in several ways since the data were collected. In particular, CGM device use has increased substantially in our patient population due to expanded insurance coverage, particularly among those with public insurance.

In addition, several new integrated pump-CGM systems providing automated insulin delivery have been released since our study concluded, and questions of access, use, and comfort with these new systems among Spanish-language—preferring children is an important area for future inquiry.

This study confirms that Spanish-language preference is associated with lower rates of insulin pump use in children with T1D, even after controlling for age, gender, age at diagnosis, and type of insurance. In addition, our analysis suggests that Spanish-language—preferring families experience higher rates of insulin pump discontinuation than their English-speaking non-Hispanic White counterparts.

This finding has not previously been reported in the pediatric T1D literature. Finally, our study demonstrates that Spanish-language—preferring families are more likely than non-Hispanic White controls to report concerns over learning to use insulin pumps, highlighting the need for improved Spanish-language instructions about insulin pumps and increased support for Spanish-language—preferring families after pump technology has been adopted.

There was no external funding source. Edited by YK Lin; submitted org Skip to Main Content Skip to Footer. Disparities in Insulin Pump Use Among Spanish-Speaking Children With Type 1 Diabetes Compared to Their Non-Hispanic White Peers: Mixed Methods Study Disparities in Insulin Pump Use Among Spanish-Speaking Children With Type 1 Diabetes Compared to Their Non-Hispanic White Peers: Mixed Methods Study Authors of this article: Lindsey Loomba 1 ; Shaila Bonanno 2 ; Diana Arellano 3 ; Stephanie Crossen 1 ; Nicole Glaser 1.

Article Authors Cited by 3 Tweetations 2 Metrics. Original Paper. Lindsey Loomba 1MD ; Shaila Bonanno 2MD ; Diana Arellano 3RN ; Stephanie Crossen 1MD, MPH ; Nicole Glaser 1MD 1 Department of Pediatrics, University of California, Davis, Sacramento, CA, United States 2 Department of Pediatrics, University of Washington, Seattle, WA, United States 3 UCSF Benioff Children's Hospital, San Francisco, CA, United States.

Corresponding Author: Lindsey Loomba, MD Department of Pediatrics University of California, Davis Stockton Blvd Sacramento, CA, United States Phone: 1 Fax:1 Email: laalbrecht ucdavis. disparities ; type 1 diabetes ; Spanish-speaking ; insulin pump ; children ; diabetes ; diabetes mellitus ; insulin ; glucose monitoring.

: Insulin pump therapy inclusiveness

How Does an Insulin Pump Work: Types and How to Use It The pharmacokinetics of insulin after continuous subcutaneous infusion or bolus subcutaneous injection in diabetic patients. Table 2. A, Analysis in the propensity score—matched cohort including patients using injection therapy and patients using pump therapy. You are not required to answer, but we hope you will. Analytics analytics.
Tandem continues commitment to diversity and inclusion in 2022 Speak with your diabetes care team about your Insulin pump therapy inclusiveness. It also infuses niclusiveness bolus to cover mealtime tgerapy snack time insulin requirements. Episodes of hypoglycemia were identified by appropriate symptoms reported by caregivers. Sylmar, Calif MiniMed Technologies. Ann Intern Med Sep 04; 5 [ CrossRef ] [ Medline ] Lipman TH, Smith JA, Patil O, Willi SM, Hawkes CP.
Insulin Pump Therapy - Children with Diabetes

Some pumps can actually calculate bolus insulin doses once they are fed the blood glucose readings. Other features include programmable insulin-to-carbohydrate ratios,programmable correction factors, and an automatic calculation of insulin on board the amount of insulin remaining active from the previous bolus.

When properly programmed, these pumps will recommend insulin doses to the user based on current glucose level, anticipated food intake, and other factors.

However, it is still up to the user to accept or override these doses and deliver the insulin. Table 1 presents a list of insulin pumps currently available.

Although all insulin pumps provide the same basic functionality, each brand and model offers specific features that should be considered.

A square wave bolus delivers a single insulin dose over an extended period, whereas a dual wave bolus delivers one dose of insulin immediately, and a second dose over the next few hours. Clearly, these features would be valuable for patients who are interested in using more advanced treatment strategies.

Therefore, it is important to consider the value and relevance of the specific features offered with each pump. Selection criteria should also address other considerations, such as customer service and local training and support services. Using rapid-acting insulin boluses at mealtimes with hour continuous basal insulin infusion allows patients to closely mimic normal physiology.

This, in turn, facilitates tighter glycemic control with less hypoglycemia. The cost of insulin pump therapy can be an obstacle for some patients. Most insurance companies, including Medicare and Medicaid plans, cover the cost of insulin pump therapy for patients with type 1 diabetes after prospective approval.

Reimbursement for insulin pump therapy for type 2 patients is often more difficult to obtain. Most manufacturers provide comprehensive assistance to help patients obtain reimbursement. Several recent studies have shown that the rapid-acting insulin analogs aspart, lispro, and glulisine demonstrate a more physiological profile than buffered human regular insulin by mimicking mealtime and basal insulin secretion without higher risk of hypoglycemia or ketoacidosis in well-educated diabetic patients.

There are no important observable differences among the rapid-acting analogs that are currently available. Testing of insulin stability has shown that these insulins are stable when used in insulin pumps.

Although there has been some concern about rare incidents of blockages or clogging, there is no clear evidence that any of the insulin analogs is more or less susceptible to causing occlusions. In a randomized study that compared aspart to lispro and buffered regular when used in pump therapy, Bode et al.

Moreover, only a small percentage of these blockages coincided with a hyperglycemic episode. Some problems have been reported linking insulin to immunological reactions.

Anyone with the motivation to achieve tighter glucose control and the ability to pay for this technology is a good candidate for insulin pump therapy. Patients must be willing to learn general principles of diabetes self-management and specific skills, such as carbohydrate counting and insulin correction and adjustment.

In short, patients must be willing to learn advanced insulin management skills before moving to an insulin pump. Patients then must be willing and able to master insulin pump operation and adhere to their prescribed regimens. Table 2 presents key attributes of a good insulin pump candidate.

Table 3 provides a checklist for knowledge and skills patients will need to be successful with pump therapy. After patients have learned these skills, they must then be willing to follow the prescribed treatment plan. This includes a willingness to monitor blood glucose levels at least four to six times daily and to document the results.

Successful insulin pump therapy also requires adherence to manufacturer instructions regarding the frequency for changing the infusion set. It is important to inform patients about insulin pump therapy before initiating treatment to avoid misunderstandings and unrealistic expectations.

Patients need to understand the strengths and limitations of pump therapy what an insulin pump will and will not do and the initial and ongoing costs involved.

To be safe and successful, patients must also understand and agree to fulfill their responsibilities regarding initial and ongoing education and training and adherence to the prescribed regimen, including self-monitoring of blood glucose levels, changing of infusion sets, follow-up contact, visits with the health care team, and all other aspects of the treatment plan.

When working with adolescent patients, many clinicians have found it valuable to use behavioral contracts that provide a detailed list of responsibilities the patient agrees to fulfill. Figure 1 presents a sample contract.

Important considerations. Patient self-care behaviors are rarely constant; this is particularly true with adolescents. An early study by Klingensmith et al.

However, a more recent study by Boland et al. The researchers concluded that insulin pump therapy provides an effective means to lower A1C levels and reduce the risk of hypoglycemia without adversely affecting psychosocial outcomes in adolescents with type 1 diabetes. In short, adherence to prescribed insulin pump therapy, particularly in adolescents, is a complicated challenge with multiple issues.

However, proper identification of problems and appropriate intervention can result in reestablishment of good glycemic control. In our own practices, we have observed that it takes an average of 6 months before patients feel comfortable with their pump therapy. Frequent contact with the health care team usually shortens this time frame.

Insulin pump therapy is not as complicated as many believe. However,clinicians must possess the necessary knowledge, skills, and resources to safely initiate insulin pump therapy and provide diligent follow-up care to patients.

To be successful, clinicians must be well grounded in the principles and strategies of diabetes management and basic insulin pump therapy. See Table 3. Moreover, they must take the time to learn basic and advanced strategies involved with insulin pump operation and use.

In other words, clinicians must learn and master everything their patients need to know about pump therapy, and they must be able to provide expert advice regarding pattern management, dosage adjustments, and troubleshooting.

Most busy practices have difficulty accommodating the lengthy patient visits required to provide necessary education and training in basic and advanced diabetes education skills, insulin pump operations, and troubleshooting. Therefore, clinicians who want to use insulin therapy in their practices must have access to qualified individuals who can provide initial education and training in all aspects of pump therapy and ongoing education and follow-up support to patients on a long-term basis.

Establishing a team of qualified and experienced health care providers is a prerequisite component of insulin pump use. Reliance on a health care team should not be confused with simply using the training services provided by manufacturers.

Another essential component is having after-hours coverage by an experienced clinician. Most of the major pump manufacturers provide hour technical support; however, these services are generally limited to handling mechanical problems with the pumps themselves.

They are not intended to provide acute patient care. Therefore, clinicians must ensure that qualified individuals will always be available to provide medical care and assistance to patients on pump therapy.

As discussed earlier, studies have shown insulin pump therapy to be beneficial in treating both type 1 and type 2 diabetes. This clearly creates an opportunity for many primary care physicians to incorporate insulin pump therapy into their diabetes management strategies.

However, a pediatric diabetes specialist should treat all children with type 1 diabetes up to age 18 years. Insulin pump training is analogous to diabetes self-management education in that it has three defined stages: 1 pre-pump preparation and start-up training survival skills ; 2 advanced pump training lifestyle self-management ; and 3 maintenance and expansion of competencies continuing education.

This article focuses on the first stage,pre-pump preparation and start-up training, because it is crucial to patients'long-term success with pump therapy.

Pre-pump preparation. A crucial component of pre-pump preparation is ensuring that patients receive comprehensive education and training in the fundamentals of diabetes self-management. Without a solid understanding of basic self-management skills, initiating insulin pump therapy is neither safe nor effective.

Once a patient can demonstrate proficiency in basic self-management skills, the next step is to start the patient on a basal-bolus insulin regimen with frequent blood glucose monitoring.

This is where advanced management skills i. The checklist provided in Table 3 can be used to make this assessment. It will also be necessary to assess the need for a new or modified meal plan; between-meal and bedtime snacks are not required with basal-bolus therapy or insulin pump therapy.

Start-up training. Patients must be able to demonstrate proficiency in all aspects of pump operation. Once patients have completed their education and training, they are ready to begin pump therapy. Many diabetes experts have patients complete 2 consecutive days of training to get familiar with their pumps and work through any issues they may be having.

Patients will then come back 3 days later,giving the clinician an opportunity to answer questions and assess competency. Depending on the situation, clinicians may ask patients to return in 2 weeks,6 weeks, and then 3 months for follow-up.

During this stage, patients will be asked to monitor their blood glucose six to eight times per day. As a safeguard, clinicians should be prepared to collect these data as often as daily or as infrequently as every week until patients' glucose levels are stable and controlled.

It is also important to provide patients with phone numbers for emergencies. Although many insulin pump manufacturers will provide limited phone support by the pump trainer, patients must also have emergency access to their health care team.

After patients become competent and comfortable with their insulin pumps,clinicians should then move them to more advanced pump therapy, such as using custom bolusing, alternate basal rate profiling, and temporary rates. The insulin pump itself is rarely the problem when insulin infusion is interrupted.

Usually the problem is the result of a patient inadvertently pulling out the catheter, disconnecting the tubing, or not changing the infusion set or site as prescribed. Patients should always follow up on error codes by calling the manufacturer's toll-free number for assistance.

Table 4 presents a troubleshooting checklist that patients and clinicians can use to identify and solve problems. Metabolic correction during pump failure. Although pump problems are rare, patients should always be prepared to handle a disruption in insulin infusion.

An infusion set and reservoir if traveling; patients should also store these supplies in commonly visited places.

Regardless of the cause of the problem, patients should get glucose levels under control before attempting to troubleshoot the pump or infusion set. Patients should immediately check blood glucose levels.

If glucose is elevated, they should inject a correction bolus of insulin using a syringe or pen before restarting the pump. All patients should know their correction dose before initiating insulin pump therapy. Table 5 presents a formula for calculating a correction dose.

Tight glucose control has been shown to reduce both microvascular and macrovascular complications in type 1 and type 2 diabetes. Insulin pump therapy has been shown to be safe and effective in helping patients achieve good glycemic control.

However, successful insulin pump therapy is dependent on each patient's ability and motivation to learn to use insulin pumps correctly; comprehensive initial and ongoing education delivered by qualified clinicians is the key.

In addition, patients must have strong, ongoing support from an experienced health care team as they learn to use more advanced insulin pump strategies.

Insulin pump therapy is not as complicated as many believe; however, clinicians must be willing to acquire the knowledge and training necessary to safely and effectively use this important tool to manage diabetes in nonspecialty practices.

Skyler, MD, MACP, is a professor in the Division of Endocrinology, Diabetes, and Metabolism and associate director of the Diabetes Research Institute at the University of Miami Miller School of Medicine in Florida.

Steven Ponder, MD, FAAP, CDE, is medical director of Children's Diabetes and Endocrine Center at Driscoll Children's Hospital in Corpus Cristi, Tex. Davida F. Kruger, MSN, APRN-BC, BC-ADM, is a certified nurse practitioner at the Henry Ford Medical Center—New Center One, Division of Endocrinology and Metabolism in Detroit, Mich.

Della Matheson, RN, CDE, is a research nurse and nurse specialist at the University of Miami in Florida. Christopher G. Parkin, MS, is president of CGParkin Communications, Inc. Skyler serves on a speakers bureau for Novo Nordisk and Sanofi-Aventis; sits on advisory panels for Animas, Patton Medical, Sanofi-Aventis, Smiths Medical, and Valeritas; is a stock shareholder in Animas, Medin-go, and Patton Medical; and has received consulting fees from Eli Lilly, Medingo, Novo Nordisk, Roche Diagnostics,Sanofi-Aventis, Smiths Medical, and Valeritas.

Ponder has received honoraria for speaking engagements from Animas, which manufactures insulin pumps. Kruger has received honoraria from Novo Nordisk, Eli Lilly, and Sanofi-Aventis, all companies that manufacture insulin products that can be used in pump therapy.

Matheson has received honoraria or consulting fees from Animas and Medtronic MiniMed, both of which manufacture insulin pumps. Parkin has received consulting fees from Abbott Diabetes Care, Eli Lilly, Sanofi-Aventis,and Smiths Medical, all of which manufacture insulin pumps or insulin products that can be used in pump therapy.

Sign In or Create an Account. Search Dropdown Menu. header search search input Search input auto suggest. In particular, aspects of adherence and empowerment need to be addressed when treating diabetes with an insulin pump 11 because the high behavioral demand of CSII therapy, the need for more consistent engagement 12 , 13 , burnout 14 , depression 15 , and perceived impairment of body image 16 have an impact on adherence to and outcomes of CSII therapy.

In addition, people with diabetes can have many misconceptions about the capabilities of CSII therapy. These misconceptions can be accompanied by unrealistic expectations 17 and lead to negative emotional reactions to CSII therapy e.

In sum, CSII therapy can be considered the most demanding insulin regimen 11 , Structured diabetes education has been recognized as an integral component of diabetes therapy for decades and has been integrated into many guidelines for the treatment of diabetes 20 , Although structured diabetes education programs have been evaluated successfully, especially in type 1 diabetes, general education on intensified insulin therapy e.

CSII-specific education programs that facilitate the effective use of insulin pumps and address the psychosocial barriers of CSII use are needed. This need was highlighted by the National Institute for Health and Care Excellence 20 and the American Diabetes Association 23 , calling for structured education for CSII users.

Although almost all studies on the effectiveness of CSII therapy used some sort of instruction 6 , these trainings did not resemble a structured education program.

Consequently, existing CSII education has varied across different practices. Thus, a standardized, structured education program specifically developed for CSII users that provides the skills and knowledge required for effective use of insulin pump features and addresses psychological barriers could augment the beneficial effects of CSII therapy and standardize CSII education.

We developed a CSII-specific structured education and treatment program Insulin Pump Therapy [INPUT] that is based on a self-management approach that incorporates clinical, technological, and psychosocial components.

To assess the efficacy of this program, we conducted a randomized controlled trial of current CSII users to evaluate whether participation in this education program is more effective at lowering HbA 1c than usual care.

This investigator-initiated study was designed as an open-label, parallel, randomized controlled trial with a 6-month follow-up. It was conducted in an outpatient setting of 26 CSII-specialized secondary care practices study centers throughout Germany.

Ethics approval was obtained from the ethics committee of the German Psychological Association NH ; Berlin, Germany. Only people with diabetes currently treated with CSII therapy were eligible for the study. Additional inclusion criteria were age 16—75 years; prior participation in a structured diabetes education program on intensive insulin therapy to guarantee that all participants had the proper knowledge and basic skills to treat their diabetes with insulin ; screening HbA 1c 7.

Eligible people with diabetes and CSII therapy were recruited at each study center. Before inclusion, participants were fully informed both orally and in writing about the study and gave written informed consent.

Participants received no monetary compensation for participation in this study. Participants were randomly assigned to one of two groups: 1 participation in the INPUT treatment and education program or 2 waiting list control group with treatment as usual.

Thus, both groups used CSII therapy but differed only in whether they participated in the INPUT program. Randomization was performed centrally at the study coordinating center, whose staff were not involved with recruitment or treatment of study participants.

A computer-generated algorithm SYSTAT Because of the nature of the intervention, blinding of participants as well as the diabetes educators who provided the intervention was not possible.

The INPUT program is a structured education program that consists of 12 sessions, with each lasting 90 min. INPUT is conducted as a group program three to eight participants per group The specific content of INPUT is provided in Supplementary Table 1. Participants were educated about basal rates and their adaptation as well as about the effective use of temporary basal rates, programming different basal profiles, and adjusting prandial insulin administration with various bolus options.

Training in recognizing problematic patterns in their glucose values and strategies to fix these were covered extensively throughout the course. Participants also were trained in how to use their insulin pump to avoid acute complications, such as hypoglycemia and diabetic ketoacidosis.

Another key topic of INPUT is the psychosocial impact of CSII therapy. Throughout the course, emotional and motivational obstacles as well as negative attitudes toward diabetes and CSII therapy were addressed e. A key element of INPUT is individual goal setting. Participants discussed the individual goals they wanted to achieve within the course, reflected on the status of their goal attainment, and assessed their handling of barriers.

Between sessions, participants were instructed to complete various materials e. Family members, partners, or friends were invited to attend the 10th lesson, during which social support issues were addressed.

INPUT was conducted by a single certified diabetes educator in person on the premises of each study center. These diabetes educators were trained for 12 h to ensure a standardized conduct of INPUT. This prestudy training was conducted by a diabetologist and psychologists who addressed the medical and psychological components of INPUT.

In addition, diabetes educators received a written curriculum. Before the study start, each study center received an initiation visit. Major changes of CSII therapy were supervised by the diabetologist. The study consisted of two decisive measurement points spanning three study phases.

First, 2 weeks before the start of the intervention phase, baseline assessments were conducted. At baseline, participants completed several questionnaires, and blood samples for HbA 1c analysis were collected and sent to a central laboratory.

Second, participants randomly assigned to the INPUT group received the biweekly intervention, whereas control group participants continued with CSII therapy without additional education. Third, 6 months after the end of the intervention, follow-up measurements were taken, assessing the same variables as the baseline measurements.

The primary outcome was the change in HbA 1c from baseline to the 6-month follow-up. Laboratory personnel were blinded to the randomized treatment allocation of the study participants. As a secondary outcome, the incidence of severe hypoglycemic events requiring third-party assistance or medical intervention [injection of glucagon or glucose or associated with hospitalization] during the 6-month study period were assessed and verified by interview and documented in severe adverse event forms.

The following secondary outcomes were assessed at baseline and the 6-month follow-up to analyze change:. Use of insulin pump features temporary basal rates, basal rate profiles, bolus options, bolus calculator, analysis software, pairing with continuous glucose monitoring [CGM] was assessed through self-report.

Key demographics age, sex, education, BMI as well as medical information diabetes type, diabetes duration, duration of CSII therapy, late complications [retinopathy, nephropathy, neuropathy, diabetic foot syndrome, coronary heart disease] were retrieved from patient files and documented through a case report form completed by study personnel.

On the basis of the assumption of an expected HbA 1c difference between the two groups of 0. Primary and secondary outcomes were analyzed with ranks using van der Waerden scores i. ANCOVAs with treatment group as the between factor and baseline values as covariates were conducted for primary and secondary outcomes.

The α-level was set to 0. For the primary outcome, intention-to-treat analysis was performed, including all participants who completed baseline measurement. Missing values were replaced with baseline values.

The difference in incidence of severe hypoglycemia was analyzed through zero-inflated Poisson regression analysis to account for overdispersion of zeros. Exploratory secondary analyses were conducted to identify baseline factors as possible moderators of change in HbA 1c.

Separate linear regression analyses were performed for each baseline factor, with HbA 1c at follow-up as the dependent variable controlling for baseline HbA 1c. The main effect of the moderator variable and group as well as the interaction term between group and moderator variables were included to test for moderation.

The following moderator variables were tested: age, sex, baseline HbA 1c , use of CGM technology, duration of CSII therapy, age of onset of CSII therapy, previous diabetes education number, years since last course, regimen at last course , diabetes distress, depressive symptoms, empowerment, treatment satisfaction, recruited pool size, and study center.

In addition, secondary tests of possible mediators were performed using linear regression analyses and the Sobel z statistic for mediation.

SPSS version Participants were recruited between 1 April and 26 April Follow-up measurements were completed in February Each study center contributed one patient pool median pool size 9, interquartile range [IQR] 7— As planned, participants were randomly assigned to either the INPUT intervention or the control group, and data from a total of participants were analyzed for the per-protocol population Fig.

As seen in Table 1 , only one participant with type 2 diabetes and CSII therapy was recruited. Participants were performing CSII therapy for almost one-half of the time since their diabetes diagnosis, and the majority initiated CSII therapy at an adult age.

Late complications from medical records : retinopathy, nephropathy, neuropathy, coronary heart disease, diabetic foot syndrome. Improvement of HbA 1c in the INPUT group was present along the whole HbA 1c range because the distribution of follow-up HbA 1c values can be clearly distinguished from the distribution of baseline HbA 1c values Fig.

In contrast, the distribution of HbA 1c values for the control group showed a great overlap of baseline and follow-up, indicating that HbA 1c remained constant. Distribution of HbA 1c values at baseline and at follow-up. A : INPUT group. B : Control group. In the 6 months after the end of the intervention, a total of 55 events of severe hypoglycemia requiring third-party assistance or medical intervention were reported 11 events in the INPUT group and 44 events in the control group [0.

The results of the zero-inflated Poisson regression analyses showed that the incidence rate ratio IRR of severe hypoglycemia was 3.

Events of severe hypoglycemia requiring third-party assistance but without medical assistance for recovery were less frequent in the INPUT group than in the control group 11 vs.

The IRR for such an event was 4. Nine of the 55 episodes of severe hypoglycemia required medical assistance for recovery; all 9 events took place in the control group incidence rates 0. The proportion of participants who were affected by severe hypoglycemia requiring medical intervention was significantly lower in the INPUT group 0.

The beneficial effects on HbA 1c and severe hypoglycemia were achieved even though basal insulin doses remained unchanged Supplementary Table 2. Likelihood ratio χ 2 derived from omnibus test IRR not applicable because of zero events in the INPUT group.

Compared with the control group, the INPUT group also showed a greater improvement in diabetes self-management Δ 0. After participation in the INPUT program, participants showed a larger improvement in diabetes-specific empowerment compared with the control group Δ 1. With regard to attitudes toward CSII therapy, participants in the INPUT group also indicated that they perceived more benefits of CSII higher flexibility and better glycemic control and rated the functionality of their pump as more important than participants in the control group.

There were no differences between the groups in health-related quality of life and hypoglycemia awareness. There were also behavioral changes in the usage of pump features Table 4. Participants in the INPUT group self-reported more use of temporary basal rates and bolus options than participants in the control group.

Data are median IQR. Only the interaction between the INPUT group and age of onset of CSII therapy and recruited pool size had a significant impact on the primary outcome Supplementary Table 3 , indicating a moderating effect of those factors on change in HbA 1c.

An older age at onset of CSII therapy in the INPUT group was associated with lower HbA 1c values at follow-up. A larger group size in the INPUT group was associated with lower HbA 1c values at follow-up, hence greater improvement in HbA 1c. Mediator analyses revealed that INPUT had an indirect effect on the improvement of HbA 1c through increased diabetes self-management and the new use of CGM technologies Supplementary Table 4.

However, INPUT had an independent effect on HbA 1c reduction, even after controlling for these mediators. Attendance rates were high, with a mean number of INPUT sessions attended of After the last education session, participants in the INPUT group were asked about the conduct of the program.

These fidelity measures indicated that key elements of the INPUT intervention were implemented according to the curriculum, with an implementation rate of In addition, the INPUT curriculum contained the testing of basic therapy parameters e.

At the end of the intervention phase and even during the 6 months after, significantly more INPUT participants completed these tests compared with the control group Supplementary Table 5 , indicating the successful implementation of the intervention.

Over the total study duration time since baseline, including the intervention phase until the 6-month follow-up , a total of 19 serious adverse events of severe hypoglycemia requiring medical intervention were reported 3 in the INPUT group, 16 in the control group.

One participant in the waiting control group died shortly before the 6-month follow-up as a result of a myocardial infarction. In this randomized controlled trial, participants in both study groups performed CSII therapy without achieving optimal glycemic control. The results demonstrate that the INPUT education program reduced HbA 1c to a greater extent than usual treatment.

These effects were seen in participants with short-term as well as long-term duration of their CSII therapy. The magnitude of the HbA 1c improvement was comparable to the effects achieved by switching from MDI therapy to CSII therapy, as reported in meta-analyses 4 , 5.

Therefore, the effect of INPUT on HbA 1c can be regarded as clinically meaningful. Of note, lowering HbA 1c did not lead to worsening of hypoglycemia problems. In contrast, the incidence of severe hypoglycemia requiring third-party assistance could be reduced after participating in the INPUT program.

Thus, glycemic control was substantially improved in INPUT participants not only by improving HbA 1c but also by reducing the risk for severe hypoglycemic episodes. INPUT also led to self-reported behavioral changes toward a more frequent use of the technological features of the insulin pump.

After participation in INPUT, participants indicated that they used temporary basal rates and bolus options more frequently. In addition to improving clinical outcomes, INPUT effectively improved psychosocial outcomes. Major psychological burdens, such as diabetes distress and depressive symptoms, were reduced through participation in INPUT.

The detrimental effects of diabetes distress and depression have been widely recognized 32 — In addition, reducing diabetes distress has been reported to confer beneficial effects on the course of depression 35 , Thus, by reducing diabetes distress and depressive symptoms, participation in the INPUT program may reduce the burden associated with having diabetes or its regimen, which might positively affect prognosis.

Of note, relevant baseline variables such as age and sex and baseline levels of patient-reported outcome measures did not moderate the effect of INPUT, indicating a stable effect of INPUT across various subgroups. The only two significant moderators were age of onset and recruited pool size, indicating that INPUT is most beneficial for patients with an older age at onset of CSII therapy and larger groups.

Larger groups might have led to more observational learning and more discussion and motivation through enhanced social support. However, the size of the INPUT group was limited to three to eight participants according to the study protocol.

Thus, inferences about group sizes with more than eight participants cannot be made. Furthermore, the mediator analyses suggest that INPUT reduced HbA 1c through increased diabetes self-management and increased use of CGM technologies.

Although these mediating effects demonstrate an indirect effect of INPUT, there was still an independent effect of INPUT on HbA 1c. This study was the first to our knowledge to demonstrate the efficacy of a structured diabetes education program specifically designed for CSII therapy.

In the only other study with a structured CSII-specific education program, the Relative Effectiveness of Pumps Over MDI and Structured Education REPOSE study, the authors found no superior effect of CSII therapy in combination with CSII-specific education on glycemic control, hypoglycemia, or most psychosocial outcomes However, some major differences exist between the REPOSE study and the current study.

In the current study, all participants had received structured education on intensive insulin therapy before inclusion and were already performing CSII therapy, whereas in the REPOSE study, patients were switched to CSII therapy.

Therefore, the effect of INPUT can be regarded as a specific education effect that is independent of switching to CSII therapy. Because CSII therapy costs notably more than MDI therapy, a relatively inexpensive intervention such as structured CSII-specific group education potentially could enhance the cost-effectiveness of this treatment approach.

The following limitations must be taken into account. First, the waiting control design cannot exclude an attention effect that should be considered. In addition, because the intervention was group education, enhanced peer support may have contributed to some of the effects.

However, as the mediation analysis demonstrated, INPUT also had indirect effects on the primary outcome through specific behavioral changes. Thus, the attention and peer support effects cannot account fully for the findings.

Second, incidence of severe hypoglycemia relied on self-report. Although study personnel validated the self-reports of severe hypoglycemic episodes, these episodes could not be validated by glycemic data. In addition, the effects on hypoglycemic episodes relied only on a small number of patients.

Similarly, use of pump features also relied on self-report. Third, almost all participants had type 1 diabetes. We decided to keep the only participant with type 2 diabetes in the analyses because this participant was recruited according to the study protocol, fulfilled all inclusion criteria, and completed the study in compliance with the study protocol.

Although the majority of CSII users have type 1 diabetes, the number of people with type 2 diabetes on CSII therapy is growing. Hence, the generalizability of the study is limited. Fourth, diabetes education programs are complex interventions 38 and therefore, depend on factors such as experience of the diabetes educator and group composition.

However, diabetes educators were trained for 12 h in the conduct of INPUT, received a written curriculum, and had an initiation visit shortly before the study start to ensure a standardized conduct. A strength of the study was that the intervention was delivered in a naturalistic setting of regular diabetes care, which also may have led to the extremely small dropout rate.

In summary, this randomized controlled trial demonstrated that addressing the human factor within CSII therapy through structured, CSII-specific education leads to improvements in medical, behavioral, and psychosocial outcomes. Improvement in glycemic control was comparable to the effect of CSII therapy itself and was accompanied by a reduction of severe hypoglycemia.

Taken together, the INPUT program can be considered an effective intervention that addresses skills and knowledge as well as psychological barriers and has beneficial effects on multiple clinically relevant outcomes. Clinical trial reg. NCT , clinicaltrials. The authors thank all participating study centers for their effort in recruiting and conducting this study: Diabeteszentrum am Sophie-Charlotte-Platz, Dr.

Kristina Pralle Berlin, Germany ; Diabetes- und Stoffwechselpraxis Bochum, Stephan Bonnermann Bochum, Germany ; Die Zuckerpraxis, Dr. Ewald Jammers Bramsche, Germany ; Diabetologische Schwerpunktpraxis Dr. Gölz, Dr. Stefan Gölz Esslingen, Germany ; Praxis Dres.

Armin Sammler Friedrichsthal, Germany ; Zentrum für Diabetologie Bergedorf, Dr. Jens Kröger Hamburg, Germany ; Diabetologische Schwerpunktpraxis Dr. Milek, Dr. Karsten Milek Hohenmölsen, Germany ; Gemeinschaftspraxis Dres. Kerstin König Kamen, Germany ; Hormonzentrum Karlsruhe, Sebastian Zink Karlsruhe, Germany ; Diabetologische Schwerpunktpraxis Dres.

Beqir Brahimi Kempen, Germany ; Gemeinschaftspraxis Dres.

Insulin Pumps: Relief and Choice | ADA In addition, the first patients to commence pump Hydration and immune function in youth athletes in our pujp may inclusiveeness been subject to some selection bias. editor's note: Iinclusiveness review of studies of intensified insulin treatment in adult patients with type 1 diabetes mellitus, whether using daily multiple injections or insulin pump therapy, demonstrated increased risk for hypoglycemia and ketoacidosis Egger M, et al. Lange, Dr. Enter Email Confirm Email. Table 5.

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Insulin Pumps Insulin pumps are wearable devices that Electrolyte Health with diabetes use to inclusivenesa insulin. They Improve blood circulation connected to a spot on your pkmp and give insulin for Insulin pump therapy inclusiveness to 4 days. An insulin pump is a small, wearable device that delivers insulin into your body. A review estimated that aroundpeople use insulin pumps in the United States. About 90 percent of insulin pump users have type 1 diabetes and the remaining 10 percent have type 2 diabetes.

Author: Faugal

1 thoughts on “Insulin pump therapy inclusiveness

  1. Im Vertrauen gesagt ist meiner Meinung danach offenbar. Ich werde mich der Kommentare enthalten.

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