Fasted Exercise Training Reduces Nocturnal Hypoglycemia in Overweight Adults With Type 1 Diabetes Using Automated Insulin Delivery

Introduction: Youth with type 1 diabetes (T1D) often do not achieve A1c target. This is especially problematic among Non-Hispanic Black (NHB) patients who may have less access to advanced technologies. To gain insight into ways to mitigate the disparity in glycemic outcome for high risk patients, we conducted a field trial of AID use among NHB youth with suboptimal A1c. Methods: Self-identified NHB youth with T1D, aged 10-17, A1c 8-10%, ≥2 clinic visits in past year, no DKA for 6 mon, naive to AID, willing parent, access to video conferencing were invited to participate. Participants (pts) were instructed in use of Medtronic 670G Advanced Hybrid Closed Loop pump, by a CDCES nurse. The same nurse maintained at least once a week contact/support with the family for the first 4 wks. Thereafter, pts could elect to continue AID, plus have 1-on-1 enhanced availability of nurse support as needed/desired via video conference, phone or in person for another 5 mon, in addition to clinic follow up at 3 and 6 mon. The same nurse would initiate contact at least once a month if no contact had been made by the family. Results: A total of 8 pts initially enrolled. One pt dropped out in the first wk. Remaining pts successfully initiated AID and agreed to continue beyond the first mon. One pt was discontinued after 3 mon due to inability to utilize AID safely. Three pts achieved lower A1c, 2 having A1c<8. While 4 pts had higher A1c compared to pre-AID. Overall group A1c and MBG during AID were similar to baseline. Factors potentially contributing to lack of improvement were reluctance to initiate/seek nurse contact, missing meal boluses, difficulty keeping system in automated mode. Conclusions: Most pts preferred AID to prior insulin delivery mode and safely used it. However, access to AID and increased availability of staff support were not sufficient to improve overall glycemic control for this group. Innovations to increase pt support and facilitate AID use appear necessary to optimize glycemic outcome for high risk patients. Disclosure B. McConaughey: None. S. Chalew: None.

Disclosure: M.C. Cruz Akabane: None. M. Yang Yu: None. H. Coelho: None. P. Romeiro: None. L.C. Hespanhol: None. T.L. Correa: None. V.L. De Menezes: None. Introduction: Patients with type 1 diabetes mellitus (T1DM) may experience a heightened fear of hypoglycemia, increasing risk of management and psychological complications. Automated Insulin delivery (AID) has shown improvements in glucose control in pregnant women with T1DM. However, its impact on patients’ concerns about hypoglycemia during gestation remains unclear. This study aimed to evaluate the impact of AID on patient-reported fear of hypoglycemia in pregnant and puerperal women. Methods: PubMed, Embase, and Cochrane Central databases were systematically searched in December 2023 for randomized controlled trials (RCTs) that compared AID to other standard therapies (ST) (sensor-augmented pump, multiple daily insulin injections, continuous glucose monitoring, and predictive low-glucose suspend) in adult pregnant or puerperal women with T1DM and reported the outcomes of (1) Hypoglycemia Fear Survey-II (HFS-II) total; (2) HFS-II worry scale; and (3) HFS-II behavior scale. A systematic review and meta-analysis of the findings were performed. Statistical analysis was performed using R version 4.3.2. Heterogeneity was examined with the Cochran Q test and I² statistics. Results: We included 5 RCTs (4 with pregnant women and 1 including puerperal women) in the final analysis, with a total of 150 participants, of whom 74 (49.34%) were on AID and 76 (50.66%) on ST. The mean age of the AID group was 32.2 (σ±0.8) years, while the ST was 31.74 (σ±0.99). The mean time since diagnosis of T1DM was 20.7 years (σ±1.98) in AID patients and 20.7 (σ±2.95) in ST. The mean gestational age at baseline in AID patients was 11.7 weeks (σ±2.19) and 11.5 weeks (σ±2.26) in ST. The follow-up period ranged between 4 and 12 weeks. The AID group had a baseline HFS-II behavior subscale mean score of 25.2 (σ±2.5), while ST had a mean of 24.9 (σ±2.61). AID patients presented a significant reduction of HFS-II behavior subscale score compared to ST (MD -1.84; 95% CI -3.29, -0.38; p= 0.01; I² = 0%). HFS-II worry scale score (MD -0.75; 95% CI -2.89, 1.38; p= 0.48; I² = 0%) and HFS-II total score (MD -0.19; 95% CI -2.72, 2.34; p= 0.77; I² = 0%) were not significantly different between groups. Conclusion: The significantly higher decrease in HFS-II behavior score while using AID suggests that this technology diminishes the fear of hypoglycemia, possibly enhancing pregnancy and puerperium behavior patterns in patients with T1DM. Nevertheless, there was no significant difference in improvement in the HFS-II total or worry subscale. AID seems to decrease the psychological burden of treatment, potentially improving patients’ quality of life and adherence to management plans. Keywords: Type 1 Diabetes, Hypoglycemia, Pregnancy Presentation: 6/2/2024

Automated Insulin Delivery (AID) systems have transformed diabetes management, offering more precise control over blood glucose levels by automating insulin administration. This systematic review aims to assess the effectiveness of AID systems on glycemic outcomes in the Gulf region, focusing on glycemic variability, hypoglycemia, patient satisfaction, and long-term health impacts. This systematic review followed PRISMA guidelines to evaluate the impact of Automated Insulin Delivery (AID) systems on glycemic control among diabetic patients in the Gulf region. We searched major databases, including PubMed and Embase, using a tailored strategy focused on relevant geographic and intervention terms. Studies published from 2020 onward were included, with strict eligibility criteria ensuring high-quality, region-specific data. Two reviewers independently screened studies, extracted data, and assessed risk of bias. Meta-analysis was conducted where feasible, supplemented by narrative synthesis for heterogeneous data. Subgroup and sensitivity analyses further examined outcomes by diabetes type, age, and AID system type. This review analyzed 20 studies across Gulf countries, including Saudi Arabia, Kuwait, and the UAE, to assess insulin delivery systems for diabetes management during Ramadan fasting. Advanced technologies like continuous subcutaneous insulin infusion (CSII) and automated insulin delivery (AID) systems consistently outperformed traditional methods in glycemic control, hypoglycemia prevention, fasting adaptation, and patient satisfaction. CSII reduced HbA1c by 1.3% compared to MDI, and AID ensured 89% fasting continuity. Hypoglycemia rates were 7% with CSII versus 15% with MDI. Remote-controlled pumps achieved higher satisfaction (87%) than MDI (63%). The findings underscore integrating advanced technologies into diabetes care for optimal outcomes. Advanced insulin delivery systems, including CSII and AID, demonstrate superior efficacy in glycemic control, hypoglycemia prevention, fasting adaptation, and patient satisfaction during Ramadan. These technologies significantly enhance diabetes management outcomes, emphasizing their integration into routine care. Future research should validate these findings through larger, multicenter trials across diverse populations.

Automated insulin delivery (AID) systems have improved outpatient glycemic control, reduced hypoglycemia, and enhanced quality of life for many people with diabetes. Interest is growing in translating these systems to inpatient care, where conventional insulin regimens are frequently associated with glycemic excursions and highly variable insulin requirements. We conducted a narrative review of peer-reviewed studies evaluating inpatient use of AID systems, including both hospital-initiated AID and continuation of personal outpatient AID devices during hospitalization, across medical and surgical populations. As outpatient adoption of AID systems increases, hospital clinicians are encountering patients using these technologies more frequently during admission. Available studies of both hospital-initiated AID and continued personal AID use during hospitalization suggest feasibility and safety, with improvements in time in range and no clear increase in hypoglycemia, although large-scale data remain limited. Broader implementation is constrained by important operational and regulatory barriers, including limited electronic health record integration, lack of device interoperability, regulatory clearance, and the absence of standardized institutional policies. As inpatient exposure to AID systems continues to expand, hospitals must develop infrastructure and operational policies to support safe use of personal devices and to evaluate hospital-initiated AID for patients with difficult-to-manage hyperglycemia. This review summarizes current evidence and highlights key challenges to integrating AID systems into routine inpatient diabetes care.

Use of commercially available automated insulin delivery systems in pregnant people with type 1 diabetes.

AimsThe use of automated insulin delivery (AID) systems is associated with improved glycaemic control in individuals with type 1 diabetes (T1DM). However, AID systems are more expensive than other treatment modalities for T1DM. The aim of this study was to evaluate the long‐term cost‐effectiveness of AID compared to continuous subcutaneous insulin infusion (CSII) combined with continuous glucose monitoring (CGM) in individuals with T1DM at Kuopio University Hospital, Finland.Materials and MethodsThe study included 336 individuals (mean age: 26.7 years, SD: 15.9 years), with a mean duration of diabetes of 16.6 years. Outcomes were projected in the base case of 50 years using the IQVIA CORE Diabetes Model (v10.0). Clinical data were sourced from electronic health records (EHRs), including changes in glycated haemoglobin (HbA1c) and events of hypoglycaemia and ketoacidosis. Costs were expressed in 2023 Euros (EUR).ResultsThe AID system was associated with an improvement in quality‐adjusted life expectancy of 2.3 quality‐adjusted life‐years (QALYs) compared to CSII plus CGM. These benefits came from the delayed and reduced incidence of diabetes‐related complications. The mean HbA1c improvement was 12.1 ± 11.7 mmol/mol (3.3% ± 3.2%) in the AID group. Direct costs were estimated to be 26 076 EUR higher for AID than for CSII plus CGM, and AID was associated with an incremental cost‐effectiveness ratio (ICER) of 11 184 EUR per QALY gained.ConclusionsBased on the results of this first cost‐effectiveness study conducted in Finland, a willingness‐to‐pay (WTP) threshold of 50 000 EUR per QALY gained suggests that AID is more cost‐effective than CSII plus CGM for the treatment of T1DM in a real‐world setting.

IntroductionThis study evaluated 6-month effectiveness and safety of automated insulin delivery (AID) in comparison with multiple daily injections (MDI) in pediatric and adult type 1 diabetes (T1D).Materials and methodsIndividuals with T1D, aged 2–80 years, were enrolled across 32 international centers (in the United States, Europe, Canada, and New Zealand) and randomized 1:1 to AID intervention (MiniMed™ 670G or 770G system) or MDI with or without continuous glucose monitoring. Primary endpoints were change in mean HbA1c for participants with a baseline HbA1c >8.0% (Group 1) and percentage of time spent below 70 mg/dL (%TBR <70 mg/dL [<3.9 mmol/L]) for participants with baseline HbA1c ≤8.0% (Group 2), to show superiority of AID intervention versus MDI. Safety endpoints including rates of severe hypoglycemia and diabetic ketoacidosis (DKA), and difference in diabetes treatment satisfaction score were assessed.ResultsFor Group 1, N = 56 participants (aged 29.4 ± 17.0 years) were randomized to AID intervention and N = 54 participants (aged 36.8 ± 19.6 years) were randomized to MDI. For Group 2, N = 73 (aged 37.4 ± 21.0 years) and N = 69 (aged 39.2 ± 19.3 years), respectively, were randomized to AID and MDI. Change in HbA1c (mean [95% CI] difference of −0.7% [−1.1, −0.3], P = 0.0002) and difference in %TBR <70 mg/dL (4.8% [−6.4, −3.1], P<0.001) favored AID intervention versus MDI. Rates of severe hypoglycemia (AID: 1.82/100 patient-years) and DKA (MDI: 3.52/100 patient-years) were low and met preestablished success criteria for safety.DiscussionThis large, international, multicenter randomized controlled trial demonstrates safety of the MiniMed™ 670G/770G systems. AID significantly improved HbA1c and time spent in hypoglycemia when compared with MDI, in both youth and adults living with T1D.Clinical trial registrationhttps://clinicaltrials.gov/, identifier NCT02748018.

BackgroundOpen-source automated insulin delivery (AID) systems are used by many patients with type 1 diabetes. Data are needed on the efficacy and safety of an open-source AID system.MethodsIn this multicenter, open-label, randomized, controlled trial, we assigned patients with type 1 diabetes in a 1:1 ratio to use an open-source AID system or a sensor-augmented insulin pump (control). The patients included both children (defined as 7 to 15 years of age) and adults (defined as 16 to 70 years of age). The AID system was a modified version of AndroidAPS 2.8 (with a standard OpenAPS 0.7.0 algorithm) paired with a preproduction DANA-i insulin pump and Dexcom G6 CGM, which has an Android smartphone application as the user interface. The primary outcome was the percentage of time in the target glucose range of 70 to 180 mg per deciliter (3.9 to 10.0 mmol per liter) between days 155 and 168 (the final 2 weeks of the trial).ResultsA total of 97 patients (48 children and 49 adults) underwent randomization (44 to open-source AID and 53 to the control group). At 24 weeks, the mean (±SD) time in the target range increased from 61.2±12.3% to 71.2±12.1% in the AID group and decreased from 57.7±14.3% to 54.5±16.0% in the control group (adjusted difference, 14 percentage points; 95% confidence interval, 9.2 to 18.8; P<0.001), with no treatment effect according to age (P=0.56). Patients in the AID group spent 3 hours 21 minutes more in the target range per day than those in the control group. No severe hypoglycemia or diabetic ketoacidosis occurred in either group. Two patients in the AID group withdrew from the trial owing to connectivity issues.ConclusionsIn children and adults with type 1 diabetes, the use of an open-source AID system resulted in a significantly higher percentage of time in the target glucose range than the use of a sensor-augmented insulin pump at 24 weeks. (Supported by the Health Research Council of New Zealand; Australian New Zealand Clinical Trials Registry number, ACTRN12620000034932.)

Background: The use of automated insulin delivery (AID) devices is now widespread in the management of type 1 diabetes (T1D), being used for younger and older children, adolescents, and adults. The integration of insulin pumps with continuous glucose monitors and smart management software in AID systems has significantly improved glycemic management compared to the separate application of each diabetes technology. The efficacy of AID systems has been demonstrated in randomized controlled trials (RCTs), but it is their application in real-world studies that fully demonstrates their impact for people with T1D. Summary: Available AID systems differ in how they are initiated and how they calculate and deliver insulin, which dictates the parameters that can be adjusted for each system. Here, we discuss how each system can be best optimized for each individual user, taking into account their activities of daily life, including mealtimes and physical activity, with a focus on commercially available systems for pediatrics (Medtronic MiniMed 780 G, Tandem Control-IQ, Omnipod 5, CamDiab CamAPS, and Beta Bionics iLet. Another FDA-cleared AID is the Tidepool Loop, which, although not yet in real-world on-label use, is currently utilized in its open-source format). We also look at the essential process of initiating AID therapy with these devices and how to navigate the important first steps, once the decision to start using an AID system has been made. Key Messages: AID systems should be considered for all individuals with T1D who wish to use them, with a strong emphasis on ensuring equitable access to this technology. Achieving success with AID requires comprehensive guidance, education, and support with a focus on core diabetes management principles. These systems are relatively easy to initiate, from any prior therapy and at any time, including shortly after diagnosis, using personalized, and appropriately proactive settings. Effective meal management remains crucial for achieving optimal glycemic control, while regular follow-up and timely adjustments to AID settings are essential for maintaining their effectiveness over time.

Efficacy of Treatment of Nonsevere Hypoglycemia in Adults With Type 1 Diabetes Using Oral Carbohydrates During Automated Insulin Delivery With and Without Glucagon

Introduction and Objective: A recent trial of the Omnipod® 5 AID System showed improvement in glycemic outcomes following AID initiation in a cohort of adults with insulin-treated T2D. However, limited real-world data exist on AID use and bolus behaviors in this population. This analysis evaluated real-world outcomes with Omnipod 5 use in the management of T2D. Methods: A retrospective analysis of CGM and insulin data from Omnipod 5 users with T2D in the US aged ≥18y with sufficient CGM data (≥90 days of data, ≥75% of days with ≥220 readings) was conducted for those who self-reported baseline A1C and primarily used the 110 or 120 mg/dL targets. Outcomes were stratified by baseline A1C and bolus frequency. Results: A total of 12,327 users (median age 59y; prior therapy: 44% MDI) met inclusion criteria. Users had spent a median of one year on device at the time of analysis, with 94% of time in Automated Mode. Time in range (70-180 mg/dL) and glucose management indicator by baseline A1C and bolus frequency are shown in the Figure. Among these users, time &amp;lt;70 mg/dL was low (median 0.26%). Conclusion: These findings from a large-scale real-world dataset of long-term (~1 year) AID use are similar to those reported in the pivotal trial of Omnipod 5 in T2D and provide evidence that people with T2D requiring insulin can consistently use AID long-term and achieve glycemic benefits even with elevated baseline A1C. Disclosure S.M. Oser: Research Support; Abbott. Other Relationship; American Diabetes Association, Association of Diabetes Care &amp; Education Specialists. Advisory Panel; Ascensia Diabetes Care. Research Support; Dexcom, Inc., Insulet Corporation, Leona M. and Harry B. Helmsley Charitable Trust. Advisory Panel; National Committee for Quality Assurance. Consultant; Sequel Med Tech. A.L. Peters: Advisory Panel; Medscape. Consultant; Vertex Pharmaceuticals Incorporated. Research Support; Insulet Corporation, Abbott. Other Relationship; Omada Health. F.J. Pasquel: Consultant; Insulet Corporation. Research Support; Novo Nordisk, Dexcom, Inc., Ideal Medical Technologies, Tandem Diabetes Care, Inc, Insulet Corporation. Consultant; Dexcom, Inc. G. Aleppo: Consultant; Dexcom, Inc., Insulet Corporation. Research Support; Insulet Corporation, Fractyl Health, Inc., MannKind Corporation, Tandem Diabetes Care, Inc, WellDoc, EMMES, AbbVie Inc, Bayer Pharmaceuticals, Inc. E. Miller: Advisory Panel; Abbott, Abbott Diagnostics. Other Relationship; American Diabetes Association. Speaker's Bureau; Bayer Pharmaceuticals, Inc, Boehringer-Ingelheim, Corcept Therapeutics, Eli Lilly and Company. Advisory Panel; Insulet Corporation, embecta. Speaker's Bureau; Novo Nordisk. Research Support; Abbott. L.M. Huyett: Employee; Insulet Corporation. Stock/Shareholder; Insulet Corporation. K. Miller: Employee; Insulet Corporation. L. Conroy: Employee; Insulet Corporation. Stock/Shareholder; Insulet Corporation. J.J. Mendez: Employee; Insulet Corporation. Stock/Shareholder; Insulet Corporation. T.T. Ly: Employee; Insulet Corporation. Stock/Shareholder; Insulet Corporation. Funding This study was funded by Insulet Corporation.

Prevent hypoglycaemia when using automated insulin delivery systems in type 1 diabetes requires near normal glycaemic variability

With the growing demand for livers in the field of transplantation, interest in normothermic ex situ machine perfusion (NMP) has increased in recent years. This may open the door for novel therapeutic interventions such as repair of suboptimal grafts. For successful long-term NMP of livers, blood glucose (BG) levels need to be maintained in a close to physiological range. We present an "automated insulin delivery" (AID) system integrated into an NMP system, which automatically adjusts insulin infusion rates based on continuous BG measurements in a closed loop manner during ex situ pig and human liver perfusion. An online glucose sensor for continuous glucose monitoring was integrated and evaluated in blood. A model based and a proportional controller were implemented and compared in their ability to maintain BG within the physiological range. The continuous glucose sensor is capable of measuring BG directly in human and pig blood for multiple days with an average error of 0.6mmol/L. There was no significant difference in the performance of the two controllers in terms of their ability to keep BG in the physiological range. With the integrated AID, BG was controlled within the physiological range on average in 80% and 76% of the perfusion time for human and pig livers, respectively. The presented work offers a method and shows the feasibility to maintain BG in the physiological range for multiple (up to ten) days during ex situ liver perfusion with the help of an automated AID. Maintaining BG within the physiological range is required to enable long-term ex situ liver perfusion.

The physical and psychological benefits of exercise are particularly pertinent to people with type 1 diabetes (T1D). The variability in subcutaneous insulin absorption and the delay in offset and onset in glucose lowering action impose limitations, given the rapidly varying insulin requirements with exercise. Simultaneously, there are challenges to glucose monitoring. Consequently, those with T1D are less likely to exercise because of concerns regarding glucose instability. While glucose control with exercise can be enhanced using automated insulin delivery (AID), all commercially available AID systems remain limited by the pharmacokinetics of subcutaneous insulin delivery. Although glycemic responses may vary with exercises of differing intensities and durations, the principles providing the foundation for guidelines include minimization of insulin on board before exercise commencement, judicious and timely carbohydrate supplementation, and when possible, a reduction in insulin delivered in anticipation of planned exercise. There is an increasing body of evidence in support of superior glucose control with AID over manual insulin dosing in people in T1D who wish to exercise. The MiniMed™ 780G AID system varies basal insulin delivery with superimposed automated correction boluses. It incorporates a temporary (elevated glucose) target of 8.3 mmol/L (150 mg/dL) and when it is functioning, the autocorrection boluses are stopped. As the device has recently become commercially available, there are limited data assessing glucose control with the MiniMed™ 780G under exercise conditions. Importantly, when exercise was planned and implemented within consensus guidelines, %time in range and %time below range targets were met. A practical approach to exercising with the device is provided with illustrative case studies. While there are limitations to spontaneity imposed on any AID device due to the pharmacokinetics associated with the subcutaneous delivery of current insulin formulations, the MiniMed™ 780G system provides people with T1D an excellent option for exercising safely if the appropriate strategies are implemented.

The introduction of automated insulin delivery (AID) systems represents a significant advancement in diabetes care, offering substantial benefits in outpatient settings. Although clinical studies suggest that these systems can also help improve glycemic control in acutely ill patients, several barriers remain for the actual implementation and use of these technologies in clinical practice. Three main contexts for inpatient use are addressed, including: (a) continuation of personal AID systems, (b) initiation of AID during hospitalization, and (c) initiation of AID systems at discharge. A research road map with immediate to long-term actions is presented. Initially, it calls for clinical studies assessing in-hospital efficacy, safety, and utility, addressing specific patient needs and health care operational impacts. Midterm, it focuses on practical integration, simplifying AID use, ensuring electronic health record compatibility, clarifying regulatory uncertainties, and supporting health care professionals and patients. Long-term goals include system optimizations and policy advocacy for in-hospital AID use.