Automated Insulin Delivery Research Articles

Development of a Diabetes Navigator Toolkit to Support Diabetes Technology Uptake: The IMPACT Toolkit

Advanced diabetes technologies (ADTs), including continuous glucose monitoring devices, insulin pumps, and automated insulin delivery systems, improve glycemic control in type 1 diabetes but are underutilized, particularly in minority and underserved populations. This article reports on a qualitative study to develop a diabetes toolkit. Participants identified barriers to the use of ADTs and proposed solutions to these barriers, which were then incorporated into a diabetes toolkit designed for use by a diabetes navigator or other diabetes care team members seeking to improve the uptake and sustained use of ADTs.

Efficacy and Safety of Automated Insulin Delivery Systems in Patients with Type 1 Diabetes Mellitus: A Systematic Review and Meta-Analysis.

Automated insulin delivery (AID) systems studies are upsurging, half of which were published in the last 5 years. We aimed to evaluate the efficacy and safety of AID systems in patients with type 1 diabetes mellitus (T1DM). We searched PubMed, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov until August 31, 2023. Randomized clinical trials that compared AID systems with other insulin-based treatments in patients with T1DM were considered eligible. Studies characteristics and glycemic metrics was extracted by three researchers independently. Sixty-five trials (3,623 patients) were included. The percentage of time in range (TIR) was 11.74% (95% confidence interval [CI], 9.37 to 14.12; P<0.001) higher with AID systems compared with control treatments. Patients on AID systems had more pronounced improvement of time below range when diabetes duration was more than 20 years (??.80% vs. ??.86%, P=0.031) and baseline glycosylated hemoglobin lower than 7.5% (??.93% vs. ??.87%, P=0.033). Dual-hormone full closed-loop systems revealed a greater improvement in TIR compared with hybrid closed-loop systems (??9.64% vs. ??0.87%). Notably, glycemia risk index (GRI) (??.74; 95% CI, ??.34 to ??.14; P<0.01) was also improved with AID therapy. AID systems showed significant advantages compared to other insulin-based treatments in improving glucose control represented by TIR and GRI in patients with T1DM, with more favorable effect in euglycemia by dual-hormone full closedloop systems as well as less hypoglycemia for patients who are within target for glycemic control and have longer diabetes duration.

Diabetes Device Satisfaction Among Adolescents Living With Type 1 Diabetes and Their Parents.

Diabetes technologies are valuable tools to reduce burden and enhance glycemic control, especially during adolescence. The current study sought to understand the factors associated with parent and adolescent diabetes device satisfaction. This study used cross-sectional data from 175 adolescents living with type 1 diabetes and 176 parents. Adolescent ages ranged from 12 to 19 (Mage=14.7, SD=1.89) and were balanced by gender (48% male). Kendall's W examined concordance between parent and adolescent satisfaction and bivariate correlations and paired t-tests identified correlates of satisfaction. There was low concordance (Kendall's W = 0.13) between parent and adolescent device satisfaction. Automated insulin delivery (AID) use (vs non-use) was related to higher satisfaction for adolescents (4.52 [0.71] vs 4.20 [0.87], P = .008) and parents (4.25 [0.82] vs 3.71 [0.90], P < .001). Pump use was not significantly related. Parent satisfaction was correlated with hemoglobin A1c (HbA1c; R = -0.301, P < .001), percent time-in-range (R = 0.214, P = .007), and percent time-above-range (R = -0.193, P = .015). Adolescent satisfaction was unrelated to glycemic measures. Adolescent and parent satisfaction were both related to better psychosocial functioning. Significant associations between AID use, psychosocial functioning, and glycemic control and device satisfaction remained after accounting for one another. Demographic correlates were non-significant. Adolescents and their parents have discrepant levels of satisfaction with devices. Although both adolescent and parent satisfaction are linked to use of automated technology and better psychosocial functioning, only parent satisfaction is associated with glycemia. This pattern suggests adolescents and parents hold varying priorities when it comes to device use. Acknowledging and addressing these differences may enhance the uptake and continued use of devices.

Time in tight range: A key metric for optimal glucose control in the era of advanced diabetes technologies and therapeutics.

Compared to glycated haemoglobin A1c (HbA1c), the rapidly developing continuous glucose monitoring (CGM) technology provides more detailed information about glycemic control. Amongst the new glucose metrics derived from CGM, time in target range of 3.9-10.0 mmol/L (time in range, TIR) has been widely used for the assessment of glucose control. In recent years, the rise of new technologies and therapies including advanced hybrid closed-loop automated insulin delivery systems and new hypoglycemic drugs has made it possible to achieve better glycemic control. In this context, the concept of time in tight range (TITR), defined as the percentage of time spent in target glucose range of 3.9-7.8 mmol/L, has gained increasing attention. Whilst TITR is highly correlated with TIR, there are still differences between the two metrics. These differences make TITR a more appropriate indicator in certain situations, such as when glucose levels are close to normal or when tighter glycemic control is required. This review summarizes recent studies related to TITR.

The Cross-sectional Relationship Between Use of Automatic Insulin Delivery Systems and Eating Styles Among Older Adults With Type 1 Diabetes: An Exploratory Analysis.

The number of older adults with type 1 diabetes (T1D) is increasing. Use of automated insulin delivery (AID) may influence nutrition and eating behaviors. We explored how three eating styles (restrained, external, emotional) differ between older adults with T1D who use and do not use AID. We administered a one-time electronic survey from September to November 2023 to adults ≥65 years with T1D receiving care through a university-affiliated hospital system. Clinical and demographic information was collected from medical records. Eating styles were characterized with the Dutch Eating Behavior Questionnaire. Our sample (n = 77, 95% non-Hispanic white) had mean (SD) age: 71.8 (4.1) years, diabetes duration: 33 (18) years, hemoglobin A1c (HbA1c): 6.83 (1.12%), and body mass index (BMI): 27.3 (4.7) kg/m2. Respondents reported variable eating styles, with the highest median scores for external and restrained eating and lower scores for emotional eating. Older adults using AID systems had higher median scores for emotional and external eating, and more varied restrained eating scores compared to those not using AID systems. Weak correlations were found between eating styles and HbA1c (restrained: r = -0.14; external: r = 0.08; emotional: r = 0.15), as well as between restrained (r = 0.09) and external (r = 0.04) eating with BMI, with a small correlation between emotional eating and BMI (r = 0.27). Eating styles may vary between older adult AID users and non-users. To our knowledge, this is the first study to characterize eating styles in this population, though generalizability is limited by a non-diverse and small sample with high technology use overall (eg, continuous glucose monitoring, insulin pumps).

Consensus Report on Glucagon-Like Peptide-1 Receptor Agonists as Adjunctive Treatment for Individuals With Type 1 Diabetes Using an Automated Insulin Delivery System.

With increasing prevalence of obesity and cardiovascular diseases, there is a growing interest in the use of glucagon-like peptide-1 receptor agonists (GLP-1RAs) as an adjunct therapy in type 1 diabetes (T1D). The GLP-1RAs are currently not approved by the US Food and Drug Administration for the treatment of T1D in the absence of randomized controlled trials documenting efficacy and safety of these agents in this population. The Diabetes Technology Society convened a series of three consensus meetings of clinicians and researchers with expertise in diabetes technology, GLP-1RA therapy, and T1D management. The project was aimed at synthesizing current literature and providing conclusions on the use of GLP-1RA therapy as an adjunct to automated insulin delivery (AID) systems in adults with T1D. The expert panel members met virtually three times on January 17, 2024, and April 24, 2024, and August 14, 2024, to discuss topics ranging from physiology and outcomes of GLP-1RAs in T1D to limitations of current sensors, algorithms, and insulin for AID systems. The panelists also identified research gaps and future directions for research. The panelists voted to in favor of 31 recommendations. This report presents the consensus opinions of the participants that, in adults with T1D using AID systems, GLP-1RAs have the potential to (1) provide effective adjunct therapy and (2) improve glycemic and metabolic outcomes without increasing the risk of severe hypoglycemia or diabetic ketoacidosis.

Comparison of Computational Statistical Packages for the Analysis of Continuous Glucose Monitoring Data with a Reference Software, "Ambulatory Glucose Profile," in Type 1 Diabetes.

Objective: To compare the accuracy of commonly used continuous glucose monitoring (CGM) analysis programs with ambulatory glucose profile (AGP) and Dexcom Clarity (DC) in analyzing CGM metrics in patients with type 1 diabetes (T1D). Research Methods: CGM data up to 90 days from 152 adults using the same CGM and automated insulin delivery system with T1D were collected. Six of the 19 CGM analysis programs (CDGA, cgmanalysis, Glyculator, iglu, EasyGV, and GLU) were selected to compare with AGP and DC. Metrics were compared etween all tools with two one-sided t-tests equivalence testing. For the equivalence test, the acceptable range of deviation was set as ±2 mg/dL for mean glucose, ±2% for time in range (TIR), ±1% for time above range (TAR), time above range level 1 (TAR1), time above range level 2 (TAR2), and coefficient of variation (CV). Results: All packages were compared with each other for all CGM metrics, and most of them had statistically significant differences for at least some metrics. All tools were equivalent to AGP for mean glucose, TIR, TAR, TAR1, and TAR2 within ±2 mg/dL, ±2%, ±1%, ±1% and 1%, respectively. CDGA, Glyculator, cgmanalysis, and iglu were not equivalent to AGP for CV within ±1%. All tools were equivalent to DC for mean glucose, TIR, and TAR2 within ±2 mg/dL, ±2%, and ±1%, respectively. Glyculator was not equivalent for TAR1, TAR, and CV. CGDA, cgmanalysis, and iglu were not equivalent to DC for TAR1 and TAR. EasyGV and GLU were not equivalent for TAR within ±1%. Conclusions: CGM analysis programs reported CGM metrics statistically differently, but these differences may not be applicable in clinical practice. The equivalence test also confirmed that the differences are negligible for TIR and mean glucose, while they can be important for hyperglycemic ranges and CV. A standardization for CGM data handling and analysis is necessary for clinical studies reporting CGM-generated outcomes.

Automated insulin delivery systems in elderly patients with brittle type 2 diabetes

PurposeGeriatric diabetes is complicated by the frailty of this population, and hypoglycemia with insulin is not uncommon in these patients. Automated Insulin Delivery (AID) systems may provide better glycemic control in elderly patients with brittle type 2 diabetes. MethodsThirty-four patients (≥ 60 years) including cancer patients with brittle diabetes were switched to an AID system from multiple-dose insulin (MDI) treatment. HbA1c level, weight, total daily insulin requirement, and C-peptide, creatinine, and lipids were followed for at least six months. ResultsThere were 34 patients (14 male, 41.2 %) with a median age of 67 (IQR 63.0–75.5). Six patients (17.6 %) were on chemotherapy and/or steroids (Ch/S). The patients’ initial median HbA1c % was 9.3 (IQR 7.6–11.0), c-peptide level was 0.9 (IQR 0.5–2.2) ng/mL, and median total daily insulin dose was 41 IU (IQR 32–53).Six months after the patients were switched to an AID system their HbA1c % decreased to 7.1 (IQR 6.5–8.1), p < 0.001 and c-peptide increased to 1.21 (IQR 0.2–1.7) ng/mL, p = 0.878. Total insulin dose decreased with AID systems [32 IU (IQR 23.9–37.8)), p < 0.001].There was a decrease in median HbA1c % in patients on Ch/S [8.7 (IQR 7.0–11.5) to 6.9 (IQR 6.3–9.2)] however it didn’t reach statistical significance p = 0.225. Total insulin dose also decreased without statistical significance [33 IU (IQR 41–28) to 28 (IQR 23–35), p = 0.173].The mean time in range (TIR) percent of the patients with AID systems were as follows; <54 mg/dL was 0.5 %, 56–70 mg/dL was 1.3 %, 70–180 mg/dL was 64.8 %, >180 mg/dL was 26.7 % and > 250 mg/dL was 6.7 %. ConclusionAlthough AID systems are tested mostly in young type 1 patients our results show that elderly patients with brittle type 2 diabetes also benefit from an AID system. Even in very frail patients such as cancer patients, improvement can be seen.

Use of Automated Insulin Delivery in Pregnancies Complicated by Type 1 Diabetes.

Background: Diabetes during pregnancy is associated with significant maternal and foetal health risks. Insulin requirements also change during pregnancy. This necessitates careful and effective management of diabetes. Although commonly used in clinical practice, the US Food and Drug Administration (FDA)-approved algorithms for automated insulin delivery (AID) systems do not have pregnancy-specific glycaemic targets. This review aims to evaluate the safety and efficacy of AID systems in reaching glycaemic targets in pregnant women with type 1 diabetes (T1D). Methods: In this retrospective case review, six pregnant women with T1D used three types of AID systems. Two patients used Omnipod 5, two patients used Control-I Q and two patients used Do-I t-Yourself (DIY) Loop. Results: Across trimesters, the two patients using Omnipod 5 had an average time in range (TIR) of 68 and 82%. Patients using Control-I Q had an average TIR of 77 and 69%. Both the patients using DIY Loop had an average TIR of 85%. Hypoglycaemia occurrence was minimal. Additionally, four of the six patients had uncomplicated vaginal deliveries in their third trimester, and four of the six patients achieved guideline-r ecommended TIR targets. Birth complications for the other two patients were resolved shortly after birth. Throughout the pregnancies, insulin needs approximately doubled. Conclusions: AID systems can achieve near-desired glycaemic targets with minimal hypoglycaemia in pregnant women with T1D. Randomized controlled trials are needed to confirm these findings and to win FDA indications in pregnancy.

Challenges in Beta Cell Replacement for Type 1 Diabetes.

Type 1 diabetes (T1D) presents a significant global health challenge, characterized by immune-mediated destruction of pancreatic beta-cells. Achieving therapeutic goals such as prevention of immune destruction, preservation of beta-cell mass, and automated insulin delivery remains complex due to the disease's heterogeneity. This review explores the advancements and challenges in beta-cell replacement therapies, including pancreas and islet cell transplantation, stem cell-derived β-cell generation, and biotechnological innovations. Pancreas transplantation, especially simultaneous pancreas and kidney transplantation (SPK), has evolved significantly, offering insulin independence and improved quality of life despite surgical and immunological complications. Allogeneic islet transplantation, though less invasive, faces challenges such as donor scarcity, immunosuppressive therapy, and variable long-term success. Innovations in stem cell therapy, particularly using human embryonic stem cells (hESCs) and induced pluripotent stem cells (iPSCs), promise an unlimited source of β-cells. However, translating these advances into clinical applications involves overcoming technical, biological, and ethical hurdles. Strategies such as immunomodulation, encapsulation, and genetic engineering are critical to enhancing the viability and integration of transplanted cells. This review provides a comprehensive overview of the scientific intricacies and potential of β-cell replacement therapies, emphasizing the need for continued research to address the remaining challenges and improve diabetes care outcomes.

Expert panel opinion on the optimal educational pathway for diabetes educators for training people with type 1 diabetes on the MiniMed™ 780G system: a Delphi consensus.

The MiniMed™ 780G system is an advanced insulin pump system incorporating an AHCL (Advanced Hybrid Close Loop) algorithm that automatically adjusts insulin delivery based on glucose levels. All guidelines recommend the use of Automated Insulin Delivery therapy for people with type 1 diabetes (PWT1D) and they highlight that a specifically trained and expert team should provide training on HCL systems for PWT1D, but none of the publications detail the curriculum profile that diabetes educators should have. This paper aims to establish a consensus on the optimal educational pathway for diabetes educators on the MiniMed™ 780G system. An Expert Panel (EP) of 11 key opinion educators in diabetes technology in the EMEA area was assembled. Using the Delphi method, a consensus questionnaire based on the literature research was created, discussed and validated by the EP members. An agreement level of ≥ 75% was considered a strong consensus. EP members had on average 16.3 years of clinical experience and followed at least 50 PWT1D using the MiniMed™ 780G system. All EP members agreed that a structured educational pathway to train diabetes educators in the use of the MiniMed™ 780G system is needed. 100% of the EP members agreed that the pathway should include a mentorship programme and in-field training; 90% agreed on using face-to-face training with the support of e-learning modules. The EP members believed that minimum competency standards for diabetes educators around the principles of diabetes care and education are needed. The educational pathway created by the EP showed that skills are needed at an advanced level and that mentorship in developing these skills is critical. This pathway is vital for supporting the implementation of diabetes technology into everyday life and can remove barriers and increase access to PWT1D.

Impact of Hypoglycemia on Glucose Variability over Time for Individuals with Open-Source Automated Insulin Delivery Systems

This study investigates glucose conditions preceding and following various hypoglycemia levels in individuals with type 1 diabetes using open-source automated insulin delivery (AID) systems. It also seeks to evaluate relationships between hypoglycemia and subsequent glycemic variability. Methods: Analysis of continuous glucose monitor (CGM) data from 122 adults with type 1 diabetes using open-source AID from the OpenAPS Data Commons was conducted. This study comprehensively analyzed the effects of hypoglycemia on glycemic variability, covering time periods before and after hypoglycemia. Results: Glucose variability normalization post-hypoglycemia can take up to 48 h, with severe hypoglycemia (41–50 mg/dL) linked to prolonged normalization. A cyclical pattern was observed where hypoglycemia predisposes individuals to further hypoglycemia, even with AID system use. A rise in glucose levels often precedes hypoglycemia, followed by an elevated mean time above range (TAR) post-hypoglycemia, indicating a ‘rebound’ effect. The experimental results are further validated on T1DEXI data (n = 222), originating from commercial AID systems. Different hypoglycemia categorization approaches did not show significant differences in glycemic variability outcomes. The level of hypoglycemia does influence the pattern of subsequent glucose fluctuations. Conclusion: Hypoglycemia, especially at lower levels, significantly impacts subsequent glycemic variability, even with the use of open-source AID systems. This should be studied further with a broader set of commercial AID systems to understand if these patterns are true of all types of AID systems. If these patterns occur in all types of AID systems, it underscores potential opportunities for enhancements in AID algorithms and highlights the importance of educating healthcare providers and people with diabetes about post-hypoglycemia glucose variability.

Efficacy and Safety of a Tubeless AID System Compared With Pump Therapy With CGM in the Treatment of Type 1 Diabetes in Adults With Suboptimal Glycemia: A Randomized, Parallel-Group Clinical Trial.

To examine the efficacy and safety of the tubeless Omnipod® 5 Automated Insulin Delivery (AID) System compared with pump therapy with a continuous glucose monitor (CGM) in adults with type 1 diabetes with suboptimal glycemic outcomes. In this 13-week multicenter, parallel-group, randomized controlled trial performed in the U.S. and France, adults aged 18-70 years with type 1 diabetes and HbA1c 7-11% (53-97 mmol/mol) were randomly assigned (2:1) to intervention (tubeless AID) or control (pump therapy with CGM) following a 2-week standard therapy period. The primary outcome was a treatment group comparison of time in range (TIR) (70-180 mg/dL) during the trial period. A total of 194 participants were randomized, with 132 assigned to the intervention and 62 to the control. TIR during the trial was 4.2h/day higher in the intervention compared with the control group (mean difference 17.5% [95% CI 14.0%, 21.1%]; P < 0.0001). The intervention group had a greater reduction in HbA1c from baseline compared with the control group (mean ± SD -1.24 ± 0.75% [-13.6 ± 8.2 mmol/mol] vs. -0.68 ± 0.93% [-7.4 ± 10.2 mmol/mol], respectively; P < 0.0001), accompanied by a significantly lower time <70 mg/dL (1.18 ± 0.86% vs. 1.75 ± 1.68%; P = 0.005) and >180 mg/dL (37.6 ± 11.4% vs. 54.5 ± 15.4%; P < 0.0001). All primary and secondary outcomes were met. No instances of diabetes-related ketoacidosis or severe hypoglycemia occurred in the intervention group. Use of the tubeless AID system led to improved glycemic outcomes compared with pump therapy with CGM among adults with type 1 diabetes, underscoring the clinical benefit of AID and bolstering recommendations to establish AID systems as preferred therapy for this population.

GLP-1 Receptor Agonists in Overweight and Obese Individuals With Type 1 Diabetes Using an Automated Insulin Delivery Device: A Real-World Study.

Automated insulin delivery (AID) systems have improved glycemic control in individuals with type 1 diabetes (T1D) but overweight and increased cardiovascular risk remain a challenge. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are associated with improved cardiometabolic profile but are currently not approved for the treatment of T1D. Individuals with T1D at Steno Diabetes Center Copenhagen, Denmark, treated with AID and off-label GLP-1 RA for at least six months between January 2017 and May 2024 were included in a retrospective chart review study. Nineteen individuals with (median [range]) age 42 (24-60) years were included. At GLP-1 RA initiation, hemoglobin A1c (HbA1c) was 7.3% (6.1%-8.7%), HbA1c 56 (43-72) mmol/mol, body weight 91.5 (78.0-115.0) kg, and body mass index 35.4 (27.0-42.0) kg/m2. Time in range was 74% (29%-82%), time above range 25% (18%-71%) while time below range was 1% (0%-5%). After six months of treatment, body weight changed -11% (-22% to -3%; P = .001) and total daily insulin dose changed -15.1 (-32.5 to -8.2) IU (P = .004). There were no significant changes in HbA1c or other glucose measures. One person developed ketoacidosis caused by infusion set failure, but none reported severe hypoglycemia. Glucagon-like peptide-1 receptor agonist as add-on therapy for six months in individuals with obesity and AID-treated T1D led to considerable weight loss and a reduction in insulin dose.

GLP-1 Receptor Agonists Models for Type 1 Diabetes: A Narrative Review.

Glucagon-like peptide 1 (GLP-1) is a hormone that promotes insulin secretion, delays gastric emptying, and inhibits glucagon secretion. The GLP-1 receptor agonists have been developed as adjunctive therapies for type 2 diabetes to improve glucose control. Recently, there has been an interest in introducing GLP-1 receptor agonists as adjunctive therapies in type 1 diabetes alongside automatic insulin delivery systems. The preclinical validation of these systems often relies on mathematical simulators that replicate the glucose dynamics of a person with diabetes. This review aims to explore mathematical models available in the literature to describe GLP-1 effects to be used in a type 1 diabetes simulator. Three databases were examined in the search for GLP-1 mathematical models. More than 1500 works were found after searching for specific keywords that were narrowed down to 39 works for full-text assessment. A total of 23 works were selected describing GLP-1 pharmacokinetics and pharmacodynamics. However, none of the found models was designed for type 1 diabetes. An analysis is included of the available models' features that could be translated into a GLP-1 receptor agonist model for type 1 diabetes. There is a gap in research in GLP-1 receptor agonists mathematical models for type 1 diabetes, which could be incorporated into type 1 diabetes simulators, providing a safe and inexpensive tool to carry out preclinical validations using these therapies.

Ketone Management in Pediatric Diabetes Centers in the USA: Current Practices and a Call for Improved Standardization

Introduction: Diabetic ketoacidosis (DKA) is the leading cause of mortality among youth with type 1 diabetes (T1D). Guidelines for DKA prevention exist; however, specific guidance about when to check ketones and how to manage youth using insulin pumps and automated insulin delivery (AID) systems is lacking. Methods: A 35-item online survey exploring clinical ketone management practices for youth with T1D in the USA was distributed to diabetes healthcare professionals (HCPs). Survey responses, including multiple-choice and Likert scale questions, were summarized and rates of agreement and disagreement (Likert scale 4, 5 vs. 1, 2, 3) are reported. Results: In total, 123 HCPs (51% physicians, 26% diabetes educators, 19% nurse practitioners) from 47 institutions completed the survey. Seventy percent worked at academic specialty centers. Ninety-seven percent reported >50% continuous glucose monitoring use in their clinic and 72% reported >50% insulin pump use. Although 79% reported having ketone management protocols, the level and duration of hyperglycemia at which ketone monitoring was advised ranged from >200 to 350 mg/dL and from 0 min to >6 h of duration. While 72% had distinct ketone management protocols for pump users, only 29% had specific protocols for AID. Sixty-two percent agreed that DKA due to infusion site failure was a significant problem in their practice, and 70% agreed there was a need to standardize ketone management guidelines. Conclusions: The preventable nature and high incidence of DKA highlight the need to build consensus for clinical ketone management and to develop tools to facilitate management, especially as the use of diabetes technologies continues to increase.

Glycaemic outcomes in adults with type 2 diabetes over 34 weeks with the Omnipod® 5 automated insulin delivery system.

The aim was to evaluate the effect of extended use of the Omnipod® 5 automated insulin delivery (AID) system in adults with type 2 diabetes and suboptimal glycaemic control. Following an 8-week single-arm, multicentre, outpatient trial of AID in adults with type 2 diabetes and baseline ≥ 64 mmol/mol, participants were given the opportunity to continue use of the AID system in a 26-week (~6 month) extension phase. The primary safety endpoints were percentage of time with sensor glucose ≥ 250 mg/dL and < 54 mg/dL. Additional glycaemic measures, including percentage of time in range (TIR) (70-180 mg/dL) and HbA1c, were evaluated. The use of non-insulin anti-hyperglycaemic medications was permitted throughout the entire study. During the initial 8-week study, participants (N = 22) achieved a decrease in percentage of time ≥ 250 mg/dL from 27.4% ± 21.0% to 10.5% ± 8.8% (p < 0.0001), which further decreased to 9.7% ± 9.2% during the extension phase (p = 0.0002 vs. standard therapy). Percentage of time < 54 mg/dL remained low from standard therapy through extension (median [interquartile range] 0.00% [0.00%, 0.06%] vs. 0.02% [0.00%, 0.05%], p > 0.05). HbA1c decreased by 1.6% ± 1.2% (15.5 ± 13.1 mmol/mol, p < 0.0001) and TIR increased by 22.4% ± 19.2% (p < 0.0001) from standard therapy through extension with no significant change in body mass index and without an observed increase in total daily insulin requirements. These longer-term findings of Omnipod 5 AID system use demonstrate the potential value of AID in helping people with type 2 diabetes reach glycaemic targets.

Experiences of People With Type 1 Diabetes Using the iLet Bionic Pancreas in Primary Care: A Qualitative Analysis

This qualitative substudy sought to identify and understand the experiences of primary care patients with type 1 diabetes using the iLet Bionic Pancreas (Beta Bionics, Inc.) during the first clinical trial testing the automated insulin delivery (AID) system in the primary care setting. Participants in that clinical trial completed a brief semi-structured interview after the trial’s completion during which they were asked questions related to their perceptions of and experiences with using the iLet AID system. Analysis of 16 interviews revealed five major themes, which highlighted the positive and beneficial impact of the system on psychological and behavioral aspects of diabetes management.

8475 Automated Insulin Delivery System with Concentrated Regular U500 Insulin in Cushing Syndrome

Abstract Disclosure: F. Erenler: None. J. Aurora: None. Background: Concentrated regular U-500 (U-500R) insulin is commonly used in patients with T2DM, who are highly insulin-resistant, requiring more than 200 units of insulin per day. Utilizing U-500R reduces the number of daily injections, decreases injection volume, and improves cost effectiveness. There has been a case report with U-500R in an automated insulin delivery (AID) system with successful results (1). To our knowledge there is no data on AID system use in Cushing patients with T2DM using U-500R. We present a case of a patient with Cushing Syndrome (CS) with poor BG control using &amp;gt;250 units/day of SC U-500R with improved BG control after switching to Omnipod 5 AID system. Clinical Case: A 57 y.o. male initially presented with hypogonadotropic hypogonadism and subsequently diagnosed with ACTH-dependent CS, which is complicated by obesity, uncontrolled T2DM, lower extremity wounds, and DVTs. He was diagnosed with CS with multiple abnormal 1 mg dexamethasone suppression tests (DST) (max AM cortisol 5.9 mcg/dL; RR &amp;lt;1.8 mcg/dL, dexamethasone level 300), elevated urine free cortisol (UFC) (max UFC/Cr 77.6 mcg/mg/L; RR: 5-64 mcg/24-hr) and elevated salivary cortisol (max cortisol 0.2 mcg/dL; RR: &amp;lt;0.09 mcg/dL). He had suppressed cortisol with 8 mg DST. An MRI sella showed left-sided hypoechoic 0.9 cm mass. Desmopressin (DDAVP) stimulation test and Ga-68 DOTATATE-PET scan were negative. As a result of his abnormal MRI sella and elevated cortisol, he underwent transsphenoidal surgery of the left pituitary. Pathology was non-diagnostic for a pituitary adenoma. Post-op 24-hr UFC and 1 mg DST levels remained high. DDAVP stimulation test and Ga-68 DOTATATE-PET were repeated post-op and were negative. Due to complications of CS, he was initially treated with cabergoline, but switched to osilodrostat due to intolerances. He is currently on 2 mg BID dose and 24-hr UFC has been normal since then (UFC 20 mcg/L, Cr 0.67 mg, UFC/Cr 12 mcg/mg/L). He continued to have uncontrolled hyperglycemia despite normalization of UFC. On his CGM data, he was in target range (70-180 mg/dL) 5% of the time despite using U-500R 95 units SC TID. Given his severe hyperglycemia and insulin resistance, he was switched to an AID system with U-500R and his time in target range improved over 60% after a month of use and his total daily dose of insulin decreased to less than 200 units. Conclusion: U-500R proved to be safe and effective with Omnipod 5 AID. To our knowledge, this is the first reported patient with CS using U-500R with Omnipod 5 AID. In patients without CS, the AID algorithm continuously kept BG well below the set target, especially overnight. Notably, our patient did not have this overnight hypoglycemia trend, which should be expected with his disease. We are hoping to increase the awareness of U-500R with AID systems, especially for patients with incurable CS. Reference:1.Aurora J Jr, Saraswat A. J Endocr Soc. 2023;7(Suppl 1):bvad114.873. Presentation: 6/3/2024

Real-world efficacy and safety of open-source automated insulin delivery for people with type 1 diabetes mellitus: Experience from mainland China

BackgroundOpen-source automated insulin delivery systems are increasingly adopted yet predominantly discussed outside of Asia. This study aimed to describe efficacy and safety of android artificial pancreas (AAPS) in people with type 1 diabetes mellitus (T1DM) from mainland China. MethodsThis real-world study recruited people who initiated AAPS for ≥ 3 months between 2019 and 2024. Key outcomes included glycated hemoglobin A1c (HbA1c) and metrics from continuous glucose monitoring, rates of diabetic ketoacidosis (DKA) and severe hypoglycemia. Findings292 (male, 46·9 %) participants aged 25·7 (14·7, 35·0) years were included, with 183 (62·7 %) and 68 (23·3 %) using AAPS for 6 and 12 months. Prior-AAPS HbA1c was 7·6 ± 1·7 % with 44·5 % achieving < 7·0 %. After 3 months, mean HbA1c improved by −1·5 ± 2·0 % to 6·3 ± 0·8 % (P < 0.01), with 82·9 % achieving < 7.0 %. Time in range 3·9-10·0 mmol/L (TIR) improved to 78·8 ± 12·9 %, with 80·5 % achieving > 70 %, followed by time below 3·9 mmol/L of 3·9 (2·1, 6·1) %. After 12 months, HbA1c and TIR remained similar at 6·4 ± 1·0 % and 77·9 ± 12·2 %. No DKA and severe hypoglycemia was observed. InterpretationReal-world data from mainland China highlights current uptake of open-source AAPS with potential glycemic benefits. No safety signals are seen. More support to enhance access and utilization of all AID systems in this region is warranted.