Automated Insulin Delivery in Adults With Type 1 Diabetes and Suboptimal HbA1c During Prior Use of Insulin Pump and Continuous Glucose Monitoring: A Randomized Controlled Trial.

BACKGROUND: Automated insulin delivery (AID) systems offer promise in improving glycemic outcomes for individuals with type 1 diabetes. However, data on those who struggle with suboptimal glycemic levels despite insulin pump and continuous glucose monitoring (CGM) are limited. We conducted a randomized controlled trial to assess the effects of an AID system in this population. METHODS: Participants with hemoglobin A1c (HbA1c) ≥ 58 mmol/mol (7.5%) were allocated 1:1 to 14 weeks of treatment with the MiniMed 780G system (AID) or continuation of usual care (UC). The primary endpoint was change in time in range (TIR: 3·9-10·0 mmol/L) from baseline to week 14. After this trial period, the UC group switched to AID treatment while the AID group continued using the system. Both groups were monitored for a total of 28 weeks. RESULTS: Forty adults (mean ± SD: age 52 ± 11 years, HbA1c 67 ± 7 mmol/mol [8.3% ± 0.6%], diabetes duration 29 ±13 years) were included. After 14 weeks, TIR increased by 18.7% (95% confidence interval [CI] = 14.5, 22.9%) in the AID group and remained unchanged in the UC group (P < .0001). Hemoglobin A1c decreased by 10.0 mmol/mol (95% CI = 7.0, 13.0 mmol/mol) (0.9% [95% CI = 0.6%, 1.2%]) in the AID group but remained unchanged in the UC group (P < .0001). The glycemic benefits of AID treatment were reproduced after the 14-week extension phase. There were no episodes of severe hypoglycemia or diabetic ketoacidosis during the study. CONCLUSIONS: For adults with type 1 diabetes not meeting glycemic targets despite use of insulin pump and CGM, transitioning to an AID system confers considerable glycemic benefits.

Associations between use of diabetes technology and diabetes distress: a Danish cross-sectional survey of adults with type 1 diabetes.

INTRODUCTION: The study aimed to investigate independent and combined associations between insulin delivery method (insulin pump therapy (IPT) vs multiple daily injections (MDI)), glucose monitoring method (intermittently scanned continuous glucose monitoring (isCGM) and real-time continuous glucose monitoring (rtCGM) vs blood glucose metre (BGM)) and diabetes distress (DD) in adults with type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS: We combined data from two Danish questionnaire-based surveys, the Steno Tech Survey (n=1591) and the Type 1 Diabetes Distress Scale (T1-DDS) validation survey (n=4205), in which individuals aged ≥18 years with T1D were invited to participate. The 28-item T1-DDS was used to measure DD and DD scores were categorised as little or no distress (score <2.0), moderate distress (2.0-2.9) and high distress (score ≥3.0). Associations between insulin delivery, glucose monitoring methods and DD were assessed using linear regression. RESULTS: Among 2068 adults with T1D who responded to one of the surveys, the use of IPT was associated with a lower total T1-DDS score (-0.09, 95% CI 0.16 to -0.03) compared with MDI and adjusted for glucose monitoring method. The use of CGM was associated with a higher total T1-DDS score (0.11, 95% CI 0.05 to 0.18) compared with BGM and adjusted for the insulin delivery method. IPT was still associated with a lower T1-DDS score, regardless of being combined with BGM (-0.17, 95% CI -0.28 to -0.06) or CGM (-0.13, 95% CI -0.21 to -0.05), compared with MDI with CGM. No association was found between the type of CGM (isCGM vs rtCGM) and DD among either IPT or MDI users when restricting analysis to individuals using CGM. CONCLUSIONS: Among Danish adults with T1D, the use of IPT was associated with lower levels of DD, while CGM use was associated with higher levels of DD. DD should be addressed when introducing people with T1D to diabetes technology, CGM in particular. TRIAL REGISTRATION NUMBER: NCT04311164 (Results).

Associations between clinical and psychosocial factors and HbA1c in adult insulin pump users with type 1 diabetes.

AIMS: Many adults with type 1 diabetes do not achieve recommended glycemic goals despite intensive insulin therapy using insulin pumps. The aim of this study was to explore associations between clinical and psychosocial factors and HbA1c in insulin pump users to identify and prioritize areas for potential intervention. METHODS: A questionnaire-based survey covering clinical and psychosocial aspects of life with type 1 diabetes was distributed to all adult (≥ 18 years) insulin pump users in the Capital Region of Denmark. Responses were combined with data from medical records and national registries. Associations with HbA1c were modeled using regression-based machine learning. RESULTS: Of 1,591 invited individuals, 770 (48.4%) responded to the survey. Mean HbA1c among responders was 7.3% (56 mmol/mmol), and 35.6% had an HbA1c < 7.0% (53 mmol/mol). Six factors were significantly associated with HbA1c: diabetes duration (0.006% (0.1 mmol/mol) lower HbA1c per 1-year increase in diabetes duration); education (0.4% (4.3 mmol/mol) lower HbA1c with long higher education vs. primary school); insulin type (0.2% (2.2 mmol/mol) lower HbA1c with ultra-rapid-acting insulin vs. rapid-acting insulin); hypoglycemia awareness status (0.2% (2.2 mmol/mol) lower HbA1c with complete unawareness vs. full awareness); insulin device satisfaction (0.2% (2.7 mmol/mol) lower HbA1c per 1-point increase in Insulin Device Satisfaction Survey score); and diabetes distress (0.3% (3.1 mmol/mol) higher HbA1c per 1-point increase in Type 1 Diabetes Distress Scale score). CONCLUSIONS: This study identified several associations between clinical and psychosocial factors and HbA1c that may be considered when developing interventions targeted people with type 1 diabetes.

Associations between insulin pump self-management and HbA1c in type 1 diabetes.

AIMS: Insulin pump self-management is important for glycaemic outcomes. We aimed to investigate associations between self-management factors and HbA1c. METHODS: Adult insulin pump users with type 1 diabetes (n = 770) completed an online questionnaire. The latest HbA1c and demographics were extracted from national registries. Associations between HbA1c and self-management (use of advanced features, timing of infusion set change, timing of meal bolus, data-upload and pump settings adjustments) were investigated using backward selected linear regression models. RESULTS: Of the 699 responders eligible for this study, 60% were women; the median age and diabetes duration were 49 and 25 years, respectively. Significant associations with HbA1c were found for changing infusion set every 0-4 days relative to 5-10 days (-5 mmol/mol (-0.4%), p = 0.003), and for never/rarely missing a bolus (-6 mmol/mol (-0.5%), p < 0.001) relative to often missing a bolus. Timing insulin 10-15 min before meal relative to after meal start was also associated with lower HbA1c (-3 mmol/mol (-0.3%), p = 0.023). Self-adjusting pump settings showed the strongest association with lower HbA1c (-6 mmol/mol (-0.6%), p < 0.001) relative to health care professionals doing all adjustments. CONCLUSION: Self-adjusting insulin pump settings, optimal timing and few omissions of meal boluses, and timely change of infusion set are associated with lower HbA1c.

Effects of initiating insulin pump therapy in the real world: A nationwide, register-based study of adults with type 1 diabetes.

AIMS: We aimed to estimate effects of insulin pump therapy (IPT) on HbA1c level, HbA1c variability, and risk of hospitalised diabetic ketoacidosis (DKA) and severe hypoglycaemia (SH), compared with multiple daily insulin injections (MDI). METHODS: We identified a cohort of all adults with type 1 diabetes in Denmark using national registry data and assigned each individual to either IPT (treatment) or MDI (control) from 2010 to 2020. We estimated average treatment effects on the treated (ATT) and treatment effects among population subgroups using treatment-staggered difference-in-differences. RESULTS: The cohort consisted of 26,687 individuals with a collective 243,601 person-years of observation; 38,823 (16 %) were IPT person-years. We identified an ATT for HbA1c of -0.33 % (95 % CI -0.39 to -0.27; -3.6 mmol/mol [95 % CI -4.2 to -2.9]). ATTs were larger among women and individuals who were older, had highest baseline HbA1c, and used continuous glucose monitoring. ATT for HbA1c variability (-0.016 % [-0.028 to -0.0041); -0.17 mmol/mol [95 % CI -0.30 to -0.045]) corresponded to a 6.5 % decrease in the standard deviation of HbA1c. ATTs for DKA and SH corresponded to 0.52 additional and 0.11 fewer hospitalisations per 1,000 person-years, respectively. CONCLUSIONS: IPT significantly reduced HbA1c level and variability, compared with MDI. However, it also marginally increased the risk of hospitalised DKA.

Values and control in type 1 diabetes beyond glycemic outcomes: A qualitative interview study of everyday life with an insulin pump.

OBJECTIVES: Diabetes technology provides people with diabetes with new opportunities, but the transformations allowed by new technology do not necessarily provide improvements in clinical metrics applied in diabetes care. This study seeks to understand how everyday life impacts on the way people use diabetes technology and how this influences diabetes care. METHODS: Individual semi-structured qualitative interviews with 21 adults with type 1 diabetes treated with insulin pumps were recruited from two Danish diabetes outpatient clinics. Data were analyzed abductively and interpreted according to predetermined and emergent perspectives. RESULTS: Transformations in care practices derived from new technological therapies were generally well-supported by healthcare providers, but adaptation to everyday life was often challenging. More advanced technology enabled people to better control diabetes, but the control they sought was defined by individual life experiences/factors. Work involved in controlling blood glucose could cause a sense of feeling controlled by diabetes in everyday life. DISCUSSION: Everyday life with diabetes is often characterized by uncertainty and individual coping strategies are imbued with values that extend beyond purely clinical concerns and reflect the sociality of everyday life. The social values influencing individual decision-making regarding diabetes technology could be effectively expanded and enhanced with integrated peer-supported learning.

Insulin Pump Treatment in Adults with Type 1 Diabetes in the Capital Region of Denmark: Design and Cohort Characteristics of the Steno Tech Survey.

INTRODUCTION: Insulin pump therapy can improve quality of life and glycaemic outcomes for many people with type 1 diabetes (T1D). The multidimensional Steno Tech Survey study aims to investigate why some insulin pump users do not achieve treatment goals. In this article, we present the study design and analyse differences in population characteristics between responders and non-responders. METHODS: In June 2020, all 1591 insulin pump users (≥ 18 years) in the Capital Region of Denmark were invited to participate in an online questionnaire that evaluated several dimensions of insulin pump self-management and psychosocial health. Demographic, socioeconomic and clinical characteristics, including age, sex and HbA1c, of the cohort were identified via national registries. Predictors of questionnaire response/non-response were explored with logistic regression analysis. RESULTS: In the full study population, 58% were female, median age was 42 years and median HbA1c was 58 mmol/mol (7.5%); 30% had HbA1c < 53 mmol/mol (7.0%). In total, 770 individuals (48%) responded to the questionnaire. Logistic regression analysis showed that 50+ years of age (odds ratio [OR] = 2.3, 95% confidence interval [CI]: 1.4-3.8), female sex (OR = 1.3, CI: 1.02-1.6), being married (OR = 1.8, CI: 1.3-2.4) and having long higher education (OR = 1.6, CI: 1.004-2.5) were significantly associated with a higher likelihood of responding to the survey; the opposite was found for HbA1c from 64 to < 75 mmol (8.0-9.0%) (OR = 0.6, CI: 0.4-0.8) and HbA1c ≥ 75 mmol/mol (≥ 9.0%) (OR = 0.2, CI: 0.1-0.3). CONCLUSIONS: The established Steno Tech cohort enables future analysis of a range of psychosocial and behavioural aspects of insulin pump self-management. Interpretation and generalization of findings should consider observed differences between responders and non-responders.

Education programmes for persons with type 1 diabetes using an insulin pump: A systematic review.

Education is essential in insulin pump therapy, but literature in the field is limited. We systematically reviewed insulin pump education programmes and their effects in two situations as follows: (1) basic education at the start of insulin pump therapy, providing the study design enabled us to separate the effects of insulin pump therapy itself from the effects of education and (2) re-education of experienced pump users. Population: individuals ≥16 years with type 1 diabetes using insulin pumps with or without continuous glucose monitoring. Systematic searches were run in MEDLINE, Embase, CINAHL and ERIC. Original studies reporting an effect of insulin pump education programmes were included if published in English between January 1999 and May 2019. Of 988 potentially relevant studies, 48 were assessed in full text. Nine studies fulfilled the inclusion criteria, including one randomised controlled trial. Educational approaches and settings were sparsely described in all studies, and the content was usually reported as teaching points. Two studies considered basic education, reporting evaluations of knowledge and application skills, and programme satisfaction. The remaining seven studies referred to re-education. Two studies measured severe hypoglycaemic events before and after a re-education intervention, both reporting a significant event reduction. HbA1c decreased significantly in three of four studies. Two studies reported increased knowledge and improved application skills. In conclusion, this review indicates benefits from basic education and from re-education. The strength of the conclusions is limited by the low number of studies and study designs. High-quality studies are needed comparing different approaches for insulin pump education.

Skin Problems Due to Treatment with Technology Are Associated with Increased Disease Burden Among Adults with Type 1 Diabetes.

BACKGROUND: In a 4-month follow-up survey, we examined whether treatment with continuous subcutaneous insulin infusion (CSII) and/or continuous glucose monitoring (CGM) in adults with type 1 diabetes was associated with sustained skin problems and whether skin problems were associated with diabetes-related emotional distress. RESEARCH DESIGN AND METHODS: A total of 111 adult patients completed a follow-up questionnaire concerning skin problems as a result of CSII and/or CGM use. The questionnaire included a patient-reported outcome measure, the Problem Areas in Diabetes (PAID) scale. RESULTS: Current visible skin problems caused by CSII or CGM use were reported by 51 (46.0%) participants, in 34 (66.7%) of whom skin problems had been reported more than 4 months earlier. Seventy-two (64.9%) participants reported skin problems as a result of CSII use, whereas 38 (74.5%) reported skin problems owing to CGM use at some time. Itching was the most prevalent complaint. CSII-related itching was associated with a mean PAID score >20 (P = 0.01), and patients with more than one skin problem had an increased PAID score compared with those with one or no skin problems (P = 0.006). CONCLUSIONS: More than half patients treated with CSII, CGM, or both had experienced skin problems during 4 months of follow-up that were associated with increased diabetes burden. Skin problems represent a persistent health issue affecting diabetes-specific emotional distress.

Skin Problems Associated with Insulin Pumps and Sensors in Adults with Type 1 Diabetes: A Cross-Sectional Study.

BACKGROUND: In the future, widespread use of closed-loop infusion (artificial pancreas) systems to treat type 1 diabetes (T1D) may significantly improve glycemic control and enhance treatment flexibility. However, the infusion sets and plasters necessary for these treatments can cause dermatological complications that may hamper the spread of the new technology; few studies have investigated these complications in adults. The aim of this study was to describe the dermatological complications associated with continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) in adults. METHODS: A total of 118 adult patients from two different diabetes clinics completed a questionnaire concerning the dermatological complications associated with their CSII and/or CGM treatment, other treatment variables, duration of diabetes, allergies, skin care, and other pathologies. RESULTS: CGM or CSII use was associated with current eczema, scars, and wounds. In total, 34% of CSII users and 35% of CGM users currently had one or more skin lesions due to the use of these devices. We found no significant association with glycated hemoglobin (HbA1c) levels, a history of atopic dermatitis, or other skin pathologies. However, multivariate analysis revealed associations with a history of atopy and CSII-associated dermatological complications. CONCLUSIONS: Dermatological complications were present in one in every three patients and represent a significant challenge to using CSII and CGM to treat adults with T1D. Prospective studies on the causes of these complications will be required to develop preventive strategies and ensure that optimal diabetes treatment approaches that take advantage of the latest technology can be implemented.