Hybrid Closed-loop Insulin Delivery Research Articles

Closed-Loop Therapy and Sleep in Young People Newly Diagnosed With T1D and Their Parents.

A diagnosis of type 1 diabetes in a young person can create vulnerability for sleep. Historically it has been rare for young people to be offered a closed-loop system soon after diagnosis meaning that studies examining sleep under these circumstances in comparison with standard treatment have not been possible. In this study, we examine sleep in young people (and their parents) who were provided with hybrid closed-loop therapy at diagnosis of type 1 diabetes versus those who receive standard treatment over a 2-year period. The sample comprised 97 participants (mean age = 12.0 years; SD = 1.7) from a multicenter, open-label, randomized, parallel trial, where young people were randomized to either hybrid closed-loop insulin delivery or standard care at diagnosis. Sleep was measured using actigraphy and the Pittsburgh Sleep Quality Index (PSQI) in the young people, and using the PSQI in parents. Sleep in young people using hybrid closed-loop insulin delivery did not differ significantly compared with those receiving standard care (although there were nonsignificant trends for better sleep in the closed-loop group for 4 of the 5 sleep actigraphy measures and PSQI). Similarly, there were nonsignificant differences for sleep between the groups at 24 months (with mixed direction of effects). This study assessed for the first time sleep in young people using a closed-loop system soon after diagnosis. Although sleep was not significantly different for young people using closed-loop insulin delivery as compared with those receiving standard care, the direction of effects of the nonsignificant results indicates a possible tendency for better sleep quality in the hybrid closed-loop insulin delivery group at the beginning of the treatment.

Patient Satisfaction and Clinical Experience With the Tandem t:slim X2 With Control-IQ Technology Advanced Hybrid Closed-Loop Insulin Delivery System

Objective The purpose of this study was to assess patient satisfaction and clinical experience with the t:slim X2 with Control-IQ Technology automated insulin delivery system. Methods This descriptive study used a retrospective electronic health record review of all individuals trained on the Control-IQ system between December 2019 and April 2022 in one adult endocrinology practice. A total of 99 patients using the Control-IQ system for at least 3 months completed the glucose monitoring satisfaction survey (GMSS). The primary outcome was overall satisfaction with the system as measured by the GMSS. Secondary outcomes included changes in A1C from baseline at 3, 6, and 12 months; the association between GMSS scores and A1C levels; and the use of the system’s sleep activity feature to achieve lower A1C levels. Results The overall satisfaction score for patients using the system was 4.0 ± 0.6 (possible score range 1–5). A1C decreased by 0.6% 3 months, 0.7% at 6 months, and 0.8% at 12 months. Participants with A1C levels ≤7% did not experience greater satisfaction compared to those with higher A1C levels. Conclusion Participants using the Control-IQ system reported a high rate of overall satisfaction and experienced significant reductions from baseline A1C at 3, 6, and 12 months.

Insulin Requirements According to Sex and Weight in a Population of 9036 Adult Persons With Type 1 Diabetes Using Closed-Loop Insulin Delivery.

The prediction of the individual insulin needs may facilitate the initiation of insulin therapy. Our aim was to explore the relationships between body weight, sex, and daily amounts of insulin delivered by a hybrid closed-loop system. We performed a retrospective data collection of all consenting adult patients with type 1 diabetes who were equipped in Europe with the Diabeloop Generation 1 (DBLG1) hybrid closed-loop insulin delivery device between March 1, 2021 and February 28, 2023. A total of 9036 users (59% females, age 45.6 ± 14.3 years) were included, reaching a mean follow-up of 320 ± 143 days, an overall 2 887 188 days of data. We observed a mean insulin-weight ratio of 0.617 ± 0.207 U/kg (0.665 ± 0.217 for males and 0.584 ± 0.193 for females, P < .001). Exploratory analysis of a subset of 4066 patients reaching >70% Time in Range (70-180 mg/dL) showed a mean insulin-weight ratio of 0.55 ± 0.17 U/kg (P < .001) (0.59 ± 0.18 for the 1438 males and 0.53 ± 0.16 for the 2628 females). This large real-world analysis provides a quantitative estimation of the daily insulin requirements in adult patients with type 1 diabetes and shows significant differences between sex. These findings have relevant implications in the practical management of insulin therapy.

Closed-loop insulin delivery systems in patients with pancreatitis or pancreatectomy-induced diabetes: A case series

Pancreatic diabetes is associated with glycemic variability, poor metabolic control, and reduced quality of life. Though hybrid closed-loop (HCL) insulin delivery systems were not originally developed for these types of diabetes, they could address the therapeutic challenge. We aimed to evaluate long-term metabolic control in ten adult patients (mean ± SD age: 59 ± 12) treated with HCL insulin delivery systems for pancreatitis or pancreatectomy-induced diabetes. After a median of 346 days (range 64 - 631) with HCL insulin delivery, continuous glucose monitoring showed 59±19 % time-in-range [70–180 mg/dl] (versus 49±24 % before HCL insulin delivery, P = 0. 049) and 0.8 ± 1.0 % time-below-range [< 70 mg/dl] (versus 2.2 ± 2.6 %, P = 0.142), with the coefficient of glucose variability at 35.4 ± 7.6 (versus 37.8 ± 7.1, P = 0.047). HbA1c decreased from 8.5 ± 1.7 % to 7.7 ± 1.3 % [69±18 to 60±14 mmol/mol] (P = 0.076). No patient experienced an acute adverse metabolic event.

Efficacy of the hybrid closedloop insulin delivery system in children and adolescents with type 1 diabetes: a meta-analysis with trial sequential analysis.

The aim of this study was to assess the efficacy and safety of hybrid closed-loop (HCL) systems for insulin delivery in children and adolescents with type 1 diabetes (T1D). We searched Embase, PubMed, and Cochrane Library for randomized controlled trials (RCTs) published until March 2023 comparing the HCL therapy with control therapies for children and adolescents with T1D. We computed weighted mean differences (WMDs) for continuous outcomes and risk ratios (RRs) with 95% confidence intervals (CIs) for binary endpoints. Four RCTs and 501 patients were included, of whom 323 were randomized to HCL therapy. Compared with control therapies, HCL significantly improved the period during which glucose level was 70-180 mg/dL (WMD 10.89%, 95% CI 8.22-13.56%) and the number of participants with glycated hemoglobin (HbA1c) level < 7% (RR 2.61, 95% CI 1.29-5.28). Also, HCL significantly reduced the time during which glucoselevel was > 180 mg/dL (WMD-10.46%, 95% CI-13.99 to-6.93%) and the mean levels of glucose (WMD-16.67 mg/dL, 95% CI-22.25 to-11.09 mg/dL) and HbA1c (WMD-0.50%, 95% CI-0.68 to-0.31). There were no significant differences between therapies regarding time during which glucose level was < 70 mg/dL or <54 mg/dL or number of episodes of ketoacidosis, hyperglycemia, and hypoglycemia. In this meta-analysis, HCL compared with control therapies was associated with improved time in range and HbA1c control in children and adolescents with T1D and a similar profile of side effects. These findings support the efficacy of HCL in the treatment of T1D in this population.

Evaluation of hybrid closed-loop insulin delivery system in type 1 diabetes in real-world clinical practice: One-year observational study.

In 2016, the Food and Drug Administration approved the first hybrid closed-loop (HCL) insulin delivery system for adults with type 1 diabetes (T1D). There is limited information on the impact of using HCL systems on patient-reported outcomes (PROs) in patients with T1D in real-world clinical practice. In this independent study, we evaluated glycemic parameters and PROs over one year of continuous use of Medtronic's 670G HCL in real-world clinical practice. To assess the effects of hybrid closed loop system on glycemic control and quality of life in adults with T1D. We evaluated 71 patients with T1D (mean age: 45.5 ± 12.1 years; 59% females; body weight: 83.8 ± 18.7 kg, body mass index: 28.7 ± 5.6 kg/m2, A1C: 7.6% ± 0.8%) who were treated with HCL at Joslin Clinic from 2017 to 2019. We measured A1C and percent of glucose time-in-range (%TIR) at baseline and 12 months. We measured percent time in auto mode (%TiAM) for the last two weeks preceding the final visit and assessed PROs through several validated quality-of-life surveys related to general health and diabetes management. At 12 mo, A1C decreased by 0.3% ± 0.1% (P = 0.001) and %TIR increased by 8.1% ± 2.5% (P = 0.002). The average %TiAM was only 64.3% ± 32.8% and was not associated with A1C, %TIR or PROs. PROs, provided at baseline and at the end of the study, showed that the physical functioning submodule of 36Item Short-Form Health Survey increased significantly by 22.9% (P < 0.001). Hypoglycemia fear survey/worry scale decreased significantly by 24.9% (P < 0.000); Problem Areas In Diabetes reduced significantly by -17.2% (P = 0.002). The emotional burden submodules of dietary diversity score reduced significantly by -44.7% (P = 0.001). Furthermore, analysis of Clarke questionnaire showed no increase in awareness of hypoglycemic episodes. WHO-5 showed no improvements in subject's wellbeing among participants after starting the 670G HCL system. Finally, analysis of Pittsburgh Sleep Quality Index showed no difference in sleep quality, sleep latency, or duration of sleep from baseline to 12 mo. The use of HCL in real-world clinical practice for one year was associated with significant improvements in A1C, %TIR, physical functioning, hypoglycemia fear, emotional distress, and emotional burden related to diabetes management. However, these changes were not associated with time in auto mode.

A Diabetes Pregnancy Technology Roadmap: The 2023 Norbert Freinkel Award Lecture.

Norbert Freinkel emphasized the need for "more aggressive therapy with exogenous insulin" during type 1 diabetes (T1D) pregnancy. Recent advances in diabetes technology, continuous glucose monitoring (CGM), and hybrid closed-loop (HCL) insulin delivery systems allow us to revisit Freinkel's observations from a contemporary perspective. The Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial (CONCEPTT) led to international recommendations that CGM be offered to all pregnant women with T1D to help them meet their pregnancy glucose targets and improve neonatal outcomes. However, despite CGM use, only 35% of trial participants reached the pregnancy glucose targets by 35 weeks' gestation, which is too late for optimal obstetric and neonatal outcomes. The constant vigilance to CGM data and insulin dose adjustment, with perpetual worry about the impact of hyperglycemia on the developing fetal structures, leave many pregnant women feeling overwhelmed. HCL systems that can adapt to marked gestational changes in insulin sensitivity and pharmacokinetics may help to bridge the gap between the nonpregnant time in range glycemic targets (70-180 mg/dL) and the substantially more stringent pregnancy-specific targets (TIRp) (63-140 mg/dL) required for optimal obstetric and neonatal outcomes. Use of HCL (CamAPS FX system) was associated with a 10.5% higher TIRp, 10.2% less hyperglycemia, and 12.3% higher overnight TIRp. Clinical benefits were accompanied by 3.7 kg (8 lb) less gestational weight gain and consistently achieved across a representative patient population of insulin pump or injection users, across trial sites, and across maternal HbA1c categories. Working collaboratively, women, HCL technology, and health care teams achieved improved glycemia with less worry, less work, and more positive pregnancy experiences.

Hybrid Closed-Loop Versus Manual Insulin Delivery in Adults With Type 1 Diabetes: A Post Hoc Analysis Using the Glycemia Risk Index.

Glycemia risk index (GRI) is a novel composite metric assessing overall glycemic risk, accounting for both hypoglycemia and hyperglycemia and weighted toward extremes. Data assessing GRI as an outcome measure in closed-loop studies and its relation with conventional key continuous glucose monitoring (CGM) metrics are limited. A post hoc analysis was performed to evaluate the sensitivity of GRI in assessing glycemic quality in adults with type 1 diabetes randomized to 26 weeks hybrid closed-loop (HCL) or manual insulin delivery (control). The primary outcome was GRI comparing HCL with control. Comparisons were made with changes in other CGM metrics including time in range (TIR), time above range (TAR), time below range (TBR), and glycemic variability (standard deviation [SD] and coefficient of variation [CV]). GRI with HCL (N = 61) compared with control (N = 59) was significantly lower (mean [SD] 33.5 [11.7] vs 56.1 [14.4], respectively; mean difference -22.8 [-27.2, -18.3], P = .001). The mean increase in TIR was +14.8 (11.0, 18.5)%. GRI negatively correlated with TIR for combined arms (r = -.954; P = .001), and positively with TAR >250 mg/dL (r = .901; P = .001), TBR < 54 mg/dL (r = .416; P = .001), and glycemic variability (SD [r = .916] and CV [r = .732]; P = .001 for both). Twenty-six weeks of HCL improved GRI, in addition to other CGM metrics, compared with standard insulin therapy. The improvement in GRI was proportionally greater than the change in TIR, and GRI correlated with all CGM metrics. We suggest that GRI may be an appropriate primary outcome for closed-loop trials.

Closed-Loop Insulin Delivery Systems for People with Type 1 Diabetes and Chronic Very Poor Metabolic Control: It Works and Is Safe!

To evaluate the percentage of patients with type 1 diabetes (T1D) and very poor metabolic control who would agree to be treated with a hybrid closed-loop (HCL) insulin delivery system, and to assess metabolic improvement and safety. In a single center, we identified all patients aged >18 years with hemoglobin A1c (HbA1c) >11% (97 mmol/mol) before HCL treatment. We collected metabolic control and safety data up to 1 year post-HCL in those who accepted HCL after it was proposed to them. We identified 65 patients eligible for the study, 32 (50%) already used, or accepted to start using HCL. Patients were aged 18-49 years; mean(±standard deviation) baseline HbA1c was 12.5(±1.8)% (113 ± 20 mmol/mol). After 1 year, 25 patients (78%) were still using HCL and their mean HbA1c decreased to 9.4(±1.9)% (79 mmol/mol) (P < 0.001). The rate of acute metabolic events was similar during the year of follow-up to the rate in the 3 years before HCL initiation. HCL systems should be considered in patients with T1D and very poor metabolic control. ClinicalTrials registration no. NCT05282264.

Hybrid closed-loop insulin delivery system and postprandial glycemia

Hybrid closed-loop insulin delivery system and postprandial glycemia

Safety and performance of a hybrid closed-loop insulin delivery system with carbohydrate suggestion in adults with type 1 diabetes prone to hypoglycemia

AimsTo evaluate the safety and performance of a hybrid closed-loop (HCL) system with automatic carbohydrate suggestion in adults with type 1 diabetes (T1D) prone to hypoglycemia. MethodsA 32-hour in-hospital pilot study, including a night period, 4 meals and 2 vigorous unannounced 45-minute aerobic sessions, was conducted in 11 adults with T1D prone to hypoglycemia. The primary outcome was the percentage of time in range 70–180 mg/dL (TIR). Main secondary outcomes were time below range < 70 mg/dL (TBR < 70) and < 54 (TBR < 54). Data are presented as median (10th-90th percentile ranges). ResultsThe participants, 6 (54.5%) men, were 24 (22–48) years old, and had 22 (9–32) years of T1D duration. All of them regularly used an insulin pump and a continuous glucose monitoring system. The median TIR was 78.7% (75.6–91.2): 92.7% (68.2–100.0) during exercise and recovery period, 79.3% (34.9–100.0) during postprandial period, and 95.4% (66.4–100.0) during overnight period. The TBR < 70 and TBR < 54 were 0.0% (0.0–6.6) and 0.0% (0.0–1.2), respectively. A total of 4 (3–9) 15-g carbohydrate suggestions were administered per person. No severe acute complications occurred during the study. ConclusionsThe HCL system with automatic carbohydrate suggestion performed well and was safe in this population during challenging conditions in a hospital setting.

Real-World Glycemic Improvements with Hybrid Closed Loop Pumps in Youth with Type 1 Diabetes

Objective. The use of hybrid closed-loop insulin delivery systems, specifically the t:slim X2 insulin pump with Control IQ (CIQ), has demonstrated improvement in glycemic control in clinical trials and real-world settings. We sought to describe changes in glycemic control with use of CIQ in minority and nonminority youth. Research Design and Methods. This was a retrospective study of youth with type 1 diabetes (T1D) using CIQ over a 12-month period. Medical record data, pump data, and hemoglobin A1c (HbA1c) were collected from the visit prior to starting CIQ and at each clinic visit up to 12 months after starting CIQ. Continuous glucose monitor (CGM) data and HbA1c trajectory over time were compared to baseline and between minority and nonminority youth. Results. The study included 136 patients of whom 21 were minority youth (non-Hispanic Black and Hispanic), 50% were male, with median age of 13.3y, and median diabetes duration of 4.9y. After starting CIQ, baseline median HbA1c for the nonminority group decreased from 7.8% to 7.1% ( p &lt; 0.001 ), baseline median HbA1c for minority youth decreased from 9.8% to 7.8% ( p = 0.03 ), and the percentage of patients meeting target HbA1c &lt;7% increased from 26% to 45%. Both nonminority and minority youth had a significant increase in time in range and decrease of average CGM glucose ( p &lt; 0.05 ). Conclusions. HbA1c levels decreased in both minority and nonminority youth within 12 months of starting CIQ, and more patients reached the HbA1c target of less than 7%. Disparities in HbA1c between minority and nonminority youth remained and additional studies are warranted to improve this.

COMPARATIVE EFFECTIVENESS AND SAFETY OF METHODS OF INSULIN DELIVERY AND GLUCOSE MONITORING FOR DIABETES MELLITUS: A SYSTEMATIC REVIEW

Introduction: Achieving glycemic control remains difficult for patients with type 1 diabetes. We compared the efficacy of day-and-night hybrid closed-loop insulin delivery to sensor-augmented pump therapy in individuals 6 years and older with suboptimally controlled type 1 diabetes.&#x0D; The aim: This article compared effectiveness and safety of methods of insulin delivery and glucose monitoring for diabetes mellitus.&#x0D; Methods: By comparing itself to the standards set by the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) 2020, this study was able to show that it met all of the requirements. So, the experts were able to make sure that the study was as up-to-date as it was possible to be. For this search approach, publications that came out between 2013 and 2023 were taken into account. Several different online reference sources, like Pubmed and SagePub, were used to do this. It was decided not to take into account review pieces, works that had already been published, or works that were only half done.&#x0D; Result: In the PubMed database, the results of our search brought up 166 articles, whereas the results of our search on SagePub brought up 143 articles. The results of the search conducted for the last year of 2013 yielded a total 116 articles for PubMed and 89 articles for SagePub. In the end, we compiled a total of 23 papers, 15 of which came from PubMed and eight of which came from SagePub. We included six research that met the criteria.&#x0D; Conclusion: The use of a hybrid closed-loop insulin delivery system in free-living conditions for a period of twelve weeks led to clinically relevant improvements in glycaemic control while simultaneously reducing the risk of hypoglycemia in suboptimally controlled type 1 diabetes in adults, adolescents, and children aged six years and older.

Hybrid Closed Loop Therapy in Adults With Type 1 Diabetes and Above-Target HbA1c: A Real-World Observational Study.

We explored longitudinal changes associated with switching to hybrid closed loop (HCL) insulin delivery systems in adults with type 1 diabetes and elevated HbA1c levels despite the use of intermittently scanned continuous glucose monitoring (isCGM) and insulin pump therapy. We undertook a pragmatic, preplanned observational study of participants included in the National Health Service England closed loop pilot. Adults using isCGM and insulin pump across 31 diabetes centers in England with an HbA1c ≥8.5% who were willing to commence HCL therapy were included. Outcomes included change in HbA1c, sensor glucometrics, diabetes distress score, Gold score (hypoglycemia awareness), acute event rates, and user opinion of HCL. In total, 570 HCL users were included (median age 40 [IQR 29-50] years, 67% female, and 85% White). Mean baseline HbA1c was 9.4 ± 0.9% (78.9 ± 9.1 mmol/mol) with a median follow-up of 5.1 (IQR 3.9-6.6) months. Of 520 users continuing HCL at follow-up, mean adjusted HbA1c reduced by 1.7% (95% CI 1.5, 1.8; P < 0.0001) (18.1 mmol/mol [95% CI 16.6, 19.6]; P < 0.0001). Time in range (70-180 mg/dL) increased from 34.2 to 61.9% (P < 0.001). Individuals with HbA1c of ≤58 mmol/mol rose from 0 to 39.4% (P < 0.0001), and those achieving ≥70% glucose time in range and <4% time below range increased from 0.8 to 28.2% (P < 0.0001). Almost all participants rated HCL therapy as having a positive impact on quality of life (94.7% [540 of 570]). Use of HCL is associated with improvements in HbA1c, time in range, hypoglycemia, and diabetes-related distress and quality of life in people with type 1 diabetes in the real world.

282-OR: Closed-Loop Insulin Delivery Postpartum in Type 1 Diabetes

Background: Postpartum demands of caring for a newborn, breastfeeding, and sleep deprivation result in little time for self care of type 1 diabetes (T1D). Data are limited on the efficacy, safety and feasibility of closed loop insulin delivery postpartum. Methods: We performed an open label, controlled pilot trial randomizing women to hybrid closed loop insulin delivery Medtronic MiniMed™ 670G/770G in auto mode or sensor augmented insulin pump (SAP) therapy in the first 12 twelve postpartum weeks. The primary outcome was the percent time in target glucose range of 70-180 mg/dL (3.9-10.0 mmol/L). Mixed models analysis assessed between group differences in glucose measures from median start time of closed loop (8 days) to 12wks postpartum. Results: Twenty women were recruited. Two withdrew prior to randomization. The remaining 18 women completed 12 weeks of postpartum follow up in their assigned randomization group. Overall baseline mean age, duration of T1D and first pregnancy A1c was 32 years, 22 years and 6.9% respectively. Analyses adjusted for first pregnancy A1c and was intention to treat. Time in range did not differ between groups (79 ± 8.0% versus 80 ± 6.4% p =.079). Time below 70mg/dL (3.9 mmol/L) and 54mg/dL (3.0 mmol/L) was less for women randomized to closed loop versus SAP (1.6 ± .72 % vs 5.3 ± 3.3 % p &amp;lt;0.001 and .23 ± .16 % vs .95 ± .82 % p = 0.002 respectively). Time above 180 mg/dL (10 mmol/L) was not different between groups 19.5 ±8.7% vs 15.9 ±7.8% p = .823. Mean glucose was 146 ± 13 and 133 ± 14 mg/dL p &amp;lt;.001 for closed loop and SAP groups respectively. No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either group. Conclusions: Closed loop insulin delivery postpartum was associated with less hypoglycemia than SAP and slightly higher mean glucose. There were no safety concerns. Time in target glucose range was high, minimizing the potential for further improvement with closed loop. These findings are reassuring for the use of closed loop insulin delivery postpartum because of its’ potential to reduce hypoglycemia. Disclosure L.E.Donovan: Research Support; Dexcom, Inc., Medtronic, Tandem Diabetes Care, Inc., Inner Analytics. D.Feig: Advisory Panel; Novo Nordisk Canada Inc., Speaker's Bureau; Sanofi, Novo Nordisk Canada Inc. P.Lemieux: Other Relationship; Dexcom, Inc. H.R.Murphy: Advisory Panel; Medtronic, Research Support; Dexcom, Inc. R.C.Bell: None. R.J.Sigal: Research Support; Novo Nordisk. J.Ho: None. J.M.Yamamoto: None. Funding Calgary Health Trust

168-LB: A Randomized Crossover Trial Comparing Glucose Control between Different Exercise Types in Adolescents with Type 1 Diabetes Using a Hybrid Closed-Loop System

Background: Hybrid closed loop (HCL) systems may mitigate the glycemic impact of different exercise types in youth with type 1 Diabetes. Aims: Glucose was compared during and following moderate intensity exercise (MIE), high intensity interval exercise (HIE) and resistance exercise (RE) in adolescents using HCL insulin delivery. Methods: Adolescents using HCL (Medtronic Minimed 670G) undertook 40 min of MIE, HIE and RE in random order. A temporary glucose target was set 2 hours prior and during exercise with 15g carbohydrate given pre-exercise if glucose level was &amp;lt;126mg/dL. A standardized dinner was eaten 4 hours after exercise. The primary outcome was sensor glucose percentage time in range 70-180mg/dL (TIR) for 12 hours from exercise onset. Results: Twenty-eight participants (50% female); age [mean (SD)] 16.3(2.1) years; diabetes duration 9.4(4) years; HbA1c 7.3(0.6)% [56(7)mmol/mol], completed the study. In the 12 hrs following exercise onset the TIR for MIE was [median (IQR)] 76(60-92)%, HIE 87(78-96)% and RE 85(69-94)% (MIE v HIE; (p=0.015). Time &amp;gt;180mg/dL (TAR) was greater for MIE v HIE (18[3-25]% v 7[0-15]%; p=0.041). Time &amp;lt;70mg/dL (TBR) did not differ between MIE, HIE and RE [0 (0-7)%; 2(0-9)%; and 2(0-10)% respectively]. After the post-exercise meal (280-715mins), TIR for MIE was lower than HIE [86(76-96) v 67(49-87)%; p=0.003] and TAR was higher for MIE than HIE [5(0-19) v 28(0-41)%; p=0.012]. There was no significant difference between exercise types in TIR, TAR and TBR during exercise (0-40min) and before dinner (40-280mins). There was a total of 8 episodes of hypoglycemia (15mins &amp;lt;54mg/dL) each for MIE and RE and 5 for HIE. Conclusion: Glucose control in the post meal period following exercise differed between HIE and MIE but not RE. Hypoglycemia occurred across all exercise types. Disclosure R. Seckold: None. D. Morrison: None. J. Rafferty: None. S. R. Valkenborghs: None. B. Paldus: None. D. P. Zaharieva: Speaker's Bureau; American Diabetes Association. Research Support; Hemsley Charitable Trust, International Society for Pediatric and Adolescent Diabetes, Insulet Corporation. Advisory Panel; Dexcom, Inc. Speaker's Bureau; Ascensia Diabetes Care, Medtronic. M. C. Riddell: Stock/Shareholder; Supersapiens. Advisory Panel; Zealand Pharma A/S. Speaker's Bureau; Dexcom, Inc. Consultant; Lilly Diabetes. Speaker's Bureau; Novo Nordisk, Sanofi. Stock/Shareholder; Zucara Therapeutics. Advisory Panel; Zucara Therapeutics, Indigo Diabetes. Consultant; Eli Lilly and Company, Jaeb Center for Health Research. C. E. Smart: None. D. N. O'Neal: None. B. R. King: None. Funding JDRF (3-SRA-2018-532-M-B)

914-P: Veteran Experiences with Hybrid Closed-Loop (HCL) Insulin Delivery Systems in Type 1 Diabetes (T1D)

While HCL systems are increasingly recommended, data regarding veteran experiences are limited. We performed semi-structured interviews to characterize veteran experiences with HCL systems at the VA Ann Arbor Healthcare System. We used qualitative description methodology to elicit participant experiences with HCL and identify factors that could improve practice. Semi-structured interviews were conducted with veterans with T1D using an HCL device for at least 6 months. The interview guide was developed based on a modified Theory of Planned Behavior, examining the domains of attitudes/knowledge, network support, and perceived behavioral control. Inductive thematic analysis of interview transcripts was performed to understand factors that contribute to the overall HCL experience. Nine HCL users (mean age 68 years, mean A1c 7.4%, mean diabetes duration 30 years, 78% Medtronic HCL users, 22% Tandem HCL users) were interviewed. Participants reported that HCL systems ease self-management burden, increase lifestyle flexibility, and enhance the perception of safety. However, challenges in alarm fatigue exist. Participants were satisfied with their outpatient multidisciplinary network support but noted significant gaps in inpatient support for HCL use. Lastly, participants reported an improved sense of confidence in diabetes management using HCL systems. Key facilitators for successful HCL use were a desire to stay healthy for their spouse and to avoid long-term diabetes complications. Our findings confirm that HCL systems improve self-management and enhance safety in veterans as well, similar with prior reports in non-veterans with T1D. Veterans felt supported in using these systems as outpatients though challenges remain for HCL systems in the inpatient setting. Future studies should focus on improving network support for inpatient use of these devices. Disclosure S.Azzawi: None. M.Dejonckheere: None. H.Thompson: None. K.Hurren: None. V.A.Leone: None. R.Busui: Board Member; American Diabetes Association, Consultant; Averitas Pharma, Inc., Lexicon Pharmaceuticals, Inc., Nevro Corp., Novo Nordisk, Roche Diagnostics, Procter &amp; Gamble, Research Support; Novo Nordisk, Medtronic, National Institutes of Health. G.Piatt: None. J.M.Lee: Advisory Panel; GoodRx, Consultant; Tandem Diabetes Care, Inc. K.R.Mizokami-stout: None. Funding National Institute of Diabetes and Digestive and Kidney Diseases (P30DK020572-43S1)

Clinician Experiences With Hybrid Closed Loop Insulin Delivery Systems in Veterans With Type 1 Diabetes: Qualitative Study.

Hybrid closed loop (HCL) insulin pumps adjust insulin delivery based on input from a continuous glucose monitor. Several systems are FDA approved and associated with improved time in range, reduction in hemoglobin A1c, and decreased incidence of hypoglycemia. Major diabetes guidelines differ in their strength of recommendations regarding the use of HCL systems. Overall, limited information about the factors that influence HCL pump clinical decision-making is available, especially among endocrinology clinicians. The study objective is to describe the knowledge and attitudes, network support, and self-efficacy regarding HCL insulin delivery systems among endocrinology clinicians in one Veterans Affairs (VA) Healthcare System in the Midwest. Following a descriptive approach, this qualitative study used semistructured interviews and inductive thematic analysis. All endocrinologists, endocrinology fellows, and nurses in the endocrinology and metabolism department at one VA Healthcare System in the Midwest were invited to participate in one-on-one phone interviews. Thematic analysis explored clinician perspectives on HCL insulin pump systems. Participants (n=11) had experience within VA and university health care system endocrinology clinics. From their experiences, 4 themes were identified involving the evaluation and assessment of insulin pump candidates, prescribing challenges, clinical benefits of HCL pumps, and overall clinician confidence. Findings suggest that clinicians believe HCL systems have significant glycemic benefits but are not appropriate for all patients, especially those with cognitive impairment. HCL pump initiation is a multi-step process requiring an interdisciplinary team of health care clinicians to ensure patient and pump success. Furthermore, HCL systems improve clinician confidence in overall diabetes management.

Closed-loop insulin delivery in pregnant women with type 1 diabetes (CRISTAL): a multicentre randomized controlled trial – study protocol

BackgroundDespite increasing use of continuous glucose monitoring (CGM) and continuous subcutaneous insulin infusion (CSII, insulin pumps) in type 1 diabetes (T1D) in pregnancy, achieving recommended pregnancy glycaemic targets (3.5–7.8 mmol/L or 63–140 mg/dL) remains challenging. Consequently, the risk of adverse pregnancy outcomes remains high. Outside pregnancy, hybrid closed-loop (HCL) insulin delivery systems have led to a paradigm shift in the management of T1D, with 12% higher time in glucose target range (TIR) compared to conventional CSII. However, most commercially available HCL systems are currently not approved for use in pregnancy. This study aims to evaluate the efficacy, safety and cost-effectiveness of the MiniMed™ 780G HCL system (Medtronic) in T1D in pregnancy.MethodsIn this international, open-label, randomized controlled trial (RCT), we will compare the MiniMed™ 780G HCL system to standard of care (SoC) in T1D in pregnancy. Women aged 18–45 years with T1D diagnosis of at least one year, HbA1c ≤ 86 mmol/mol (≤ 10%), and confirmed singleton pregnancy up to 11 weeks 6 days will be eligible. After providing written informed consent, all participants will wear a similar CGM system (Guardian™ 3 or Guardian™ 4 CGM) during a 10-day run-in phase. After the run-in phase, participants will be randomised 1:1 to 780G HCL (intervention) or SoC [control, continuation of current T1D treatment with multiple daily injections (MDI) or CSII and any type of CGM] stratified according to centre, baseline HbA1c (< 53 vs. ≥ 53 mmol/mol or < 7 vs. ≥ 7%), and method of insulin delivery (MDI or CSII). The primary outcome will be the time spent within the pregnancy glucose target range, as measured by the CGM at four time points in pregnancy: 14–17, 20–23, 26–29, and 33–36 weeks. Prespecified secondary outcomes will be overnight TIR, time below range (TBR: <3.5 mmol/L or < 63 mg/dL), and overnight TBR. Other outcomes will be exploratory. The planned sample size is 92 participants. The study will end after postpartum discharge from hospital. Analyses will be performed according to intention-to-treat as well as per protocol.DiscussionThis large RCT will evaluate a widely used commercially available HCL system in T1D in pregnancy. Recruitment began in January 2021 and was completed in October 2022. Study completion is expected in May 2023.Trial registrationClinicalTrials.gov: NCT04520971. Registration date: August 20, 2020. https://clinicaltrials.gov/ct2/show/NCT04520971

Increasing Use of Diabetes Devices: What Do Health Care Professionals Need?

Despite evidence of improved diabetes outcomes with diabetes technology such as continuous glucose monitoring (CGM) systems, insulin pumps, and hybrid closed-loop (HCL) insulin delivery systems, these devices are underutilized in clinical practice for the management of insulin-requiring diabetes. This low uptake may be the result of health care providers' (HCPs') lack of confidence or time to prescribe and manage devices for people with diabetes. We administered a survey to HCPs in primary care, pediatric endocrinology, and adult endocrinology practices in the United States. Responding HCPs expressed a need for device-related insurance coverage tools and online data platforms with integration to electronic health record systems to improve diabetes technology uptake in these practice settings across the United States.