Automated Insulin Delivery Research Articles

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

Time in range and mean glucose cut-off points for reduction of fetal outcomes in pregnant women with type 1 diabetes using automated insulin delivery systems

AimIn pregnant women with Type 1 Diabetes (T1D), achieving a lower recommended time in range (TIRp,63–140 mg/dl) could have an impact on fetal outcomes. To determine the TIRp and mean glucose cut-off point associated with better fetal outcomes in pregnant women using automated insulin delivery (AID) systems. MethodsA prospective cohort of pregnant women with T1D, using AID systems and followed-up in Latin America was analyzed. Optimal TIRp and mean glucose cut-off points for predicting large for gestational age (LGA) were determined using the Liu method. Fetal outcomes were evaluated for the identified cut-off point and the one recommended by guidelines (TIRp > 70 %). ResultsSixty-two patients were included (mean age 31.9 ± 5.9 years, HbA1c 7.57 %±1.29 %, TIRp 59.8 %±14.6 %). 27.5 % on advanced hybrid closed loop systems (AHCL). LGA (50 vs 17.9 %,p = 0.010) and hyperbilirubinemia (45 % vs 11.8 %,p = 0.016) were more common in patients with TIRp < 59.1 %. Optimal cut-off of TIRp in the second trimester for predicting LGA was < 59.1 % (sensitivity 75 %, specificity 61 %) with an AUC of 0.68(CI 0.48–0.88). Optimal cut-off for mean glucose was 133 mg/dL (sensitivity 69 %, specificity 70 %) with an AUC of 0.70(CI 0.51–0.88) in the same trimester. Better metabolic control during the third trimester was seen in the AHCL users compared to other devices. ConclusionsTIRp > 59.1 % and mean glucose < 133 mg/dl in the second trimester, is associated with lower fetal outcomes of large for gestational age. One of the strategies that would improve TIRp is the early use of AHCL systems. Further studies are needed before a strong recommendation can be made.

Advances in diabetes technology within the digital diabetes ecosystem.

Ongoing innovations in glucose monitoring, insulin delivery, and telehealth technologies have created a digital diabetes ecosystem populated by connected tools and technologies that have been shown to improve clinical outcomes, lower costs, and reduce the burden of diabetes. Advances in connected continuous glucose monitoring devices, insulin pumps, and insulin pens have led to the development of automated insulin delivery systems that modulate insulin infusion based on sensor glucose data. Similar integrations of continuous glucose monitoring and connected blood glucose meter data into "smart" pens have lessened the guesswork of intensive insulin management for individuals who prefer traditional injection therapy. A growing number of health apps that can be accessed through smartphones and wearable devices provide information and advice that support individuals in adopting healthier lifestyles. The differences in features and functionality give users the ability to select the devices that best meet their unique requirements and preferences. This article reviews the most current digital diabetes technologies and discusses how the connectivity of these tools can create an overarching architecture of feedback mechanisms that monitor an individual's health status, motivate and enhance adherence to self-management, and provide advice and decision-support tools to clinicians as well as other members of the health care team to make living with diabetes more manageable.

12-Month Time in Tight Range Improvement with Advanced Hybrid-Closed Loop System in Adults with Type1 Diabetes.

Time in tight range (TITR) is an emerging and valuable metric for assessing normoglycemia. The latest advancement in automated insulin delivery (AID) systems, the advanced hybrid closed-loop (AHCL) systems, are particularly noteworthy for managing type1 diabetes (T1D) and enhancing glycemic control. In a real-world clinical setting, we carried out a retrospective evaluation of TITR in 42 adult subjects with T1D using the AHCL Minimed™ 780G system over a 12-month period. Within just 14days of activating the automatic mode, the AHCL Minimed™ 780G system showed rapid improvement in TITR, and in the other continuous glucose monitoring (CGM) metrics. This improvement persisted over 12months, achieving the proposed 45-50% range for effective glycemic control. The AHCL Minimed™ 780G system significantly enhances TITR, demonstrating continuous improvement throughout a 12-month follow-up period.

Children and adolescent with suboptimal control of type 1 diabetes improve during the first 2 years on automated insulin delivery system.

This study investigates the influence of the automated insulin delivery system (AID) on glycaemic control in children and adolescents with type 1 diabetes (T1D) who do not reach optimal glycaemic control with traditional treatment options. All the patients aged 7 to 16 years with T1D who initiated the AID system between 24 October 2020 and 5 January 2022 in the Helsinki University Hospital and had haemoglobin A1C (HbA1c) levels above 53 mmol/mol/7.0% (N = 79) were included. Time in tight range (TITR), time in range (TIR), HbA1c, mean sensor glucose (SG) value, time below range (TBR) and SG coefficient of variance (CV) were measured at 0, 3, 12 and 24 months. The changes in the outcome measures between the time points were included in the analyses, and statistically significant level was p-value <0.01. After the initiation of AID, glycaemic control improved, and the effect lasted throughout the study period. Between 0 and 3 months, TITR and TIR increased (mean 11.7% [10.6], mean 18.1% [standard deviation [SD] 13.7], p < 0.001), whereas HbA1c and mean SG values decreased significantly (-8.3 mmol/mol [8.7]/-2.9% [2.9], p < 0.001, -1.8 mmol/L [1.7], p < 0.001). These effects were sustainable and were still visible at 12 and 24 months. Glycaemic control in patients not reaching treatment goals improved significantly after the initiation of the AID system, and the favourable effect lasted throughout the follow-up. AID treatment could be an option for also those paediatric patients with T1D who do not have good skills in diabetes management.

A Position Statement on Diabetes with β-Cell Failure

Diabetes mellitus is a heterogeneous disease that encompasses a wide range of conditions, from mild cases to severe conditions where survival depends on insulin therapy. The Korean Diabetes Association Task Force Team for Diabetes with β-Cell Failure has established the term to classify severe refractory disease with β-cell failure. Individuals with β-cell failure are at high risk of diabetes-related complications. We propose that diabetes with β-cell failure can be diagnosed when individuals treated with multiple daily insulin injections or insulin pumps meet at least one of the following criteria: fasting C-peptide ≤ 0.6 ng/mL, non-fasting C-peptide ≤ 1.8 ng/mL, 24-hour urine C-peptide &lt; 30 μg/day, or spot urine C-peptide/creatinine ratio ≤ 0.6 nmol/mmol. Among cases of diabetes with β-cell failure, β-cell failure with absolute insulin deficiency can be diagnosed when at least one of the following criteria is met: fasting C-peptide &lt; 0.24 ng/mL, non-fasting C-peptide &lt; 0.6 ng/mL, or spot urine C-peptide/ creatinine ratio &lt; 0.2 nmol/mmol. Multiple daily insulin injections with long-acting insulin analogs and rapid-acting insulin analogs or insulin pumps are required for treatment of diabetes with β-cell failure. Continuous glucose monitoring and an automated insulin delivery system, sensor-augmented pump, or smart insulin pen, along with structured education, are necessary. We call for improvements in the relevant systems to ensure that such treatments can be provided.

An evaluation of how exercise position statement guidelines are being used in the real world in type 1 diabetes: Findings from the type 1 diabetes exercise initiative (T1DEXI)

AimsPosition statement guidelines should help people with type 1 diabetes (T1D) improve glucose outcomes during exercise. MethodsIn a 4-week observational study, continuous glucose, insulin, and nutrient data were collected from 561 adults with T1D. Glucose outcomes were calculated during exercise, post-exercise, and overnight, and were compared for sessions when participants used versus did not use exercise guidelines for open-loop (OL) and automated insulin delivery (AID) therapy. ResultsGuidelines requiring behaviour modification were rarely used while guidelines not requiring modification were often used. The guideline recommending reduced meal insulin before exercise was associated with lower time <3.9 mmol/L during exercise (−2.2 %, P=0.02) for OL but not significant for AID (−1.4 %, P=0.27). Compared to exercise with low glucose (<3.9 mmol/L) in prior 24-hours, sessions without recent low glucose had lower time <3.9 mmol/L during exercise (−1.2 %, P<0.001). The AID guideline for no carbohydrates before exercise when CGM is flat, or increasing, was not associated with improved glycaemia. ConclusionsFree-living datasets may be used to evaluate usage and benefit of position statement guidelines. Evidence suggests OL participants who reduced meal insulin prior to exercise and did not have low glucose in the prior 24 h had less time below range.

Automated Insulin Delivery for Young People with Type 1 Diabetes and Elevated A1c

BackgroundAutomated insulin delivery is the treatment of choice in adults with type 1 diabetes. Data are needed on the efficacy and safety of automated insulin delivery for children and youth with diabetes and elevated glycated hemoglobin levels.MethodsIn this multicenter, open-label randomized controlled trial, we assigned patients with type 1 diabetes in a 1:1 ratio either to use an automated insulin delivery system (MiniMed 780G) or to receive usual diabetes care of multiple daily injections or non-automated pump therapy (control). The patients were children and youth (defined as 7 to 25 years of age) with elevated glycemia (glycated hemoglobin ≥8.5% with no upper limit). The primary outcome was the baseline-adjusted between-group difference in glycated hemoglobin at 13 weeks.ResultsA total of 80 patients underwent randomization (37 to automated insulin delivery and 43 to control) and all patients completed the trial. At 13 weeks, the mean (±SD) glycated hemoglobin decreased from 10.5±1.9% to 8.1±1.8% in the automated insulin delivery group but remained relatively consistent in the control group, changing from 10.4±1.6% to 10.6±1.8% (baseline-adjusted between-group difference, −2.5 percentage points; 95% confidence interval [CI], −3.1 to −1.8; P<0.001). Patients in the automated insulin delivery group spent on average 8.4 hours more in the target glucose range of 70 to 180 mg/dl than those in the control group. One severe hypoglycemia event and two diabetic ketoacidosis events occurred in the control group, with no such events in the automated insulin delivery group.ConclusionsIn this trial of 80 children and youth with elevated glycated hemoglobin, automated insulin delivery significantly reduced glycated hemoglobin compared with usual diabetes care, without resulting in severe hypoglycemia or diabetic ketoacidosis events. (Funded by Lions Clubs New Zealand District 202F and others; Australian New Zealand Clinical Trials Registry number, ACTRN12622001454763.)

Effect of automated insulin delivery systems on person-reported outcomes in people with diabetes: a systematic review and meta-analysis

Conclusive evidence on the benefits of automated insulin delivery (AID) systems on person-reported outcomes (PROs) is missing. In this systematic review and meta-analysis, four databases (PubMed, PsycINFO, Cochrane, and GoogleScholar) were searched from inception up to August 7th, 2024. All types of studies were included if studies reported on PROs in people with diabetes using an AID system. All types of control groups in randomised controlled trials (RCT) were included. Summary data were extracted by three reviewers. Main outcomes focused on diabetes distress, fear of hypoglycaemia and quality of life. Meta-analyses were conducted for RCTs and observational studies separately. When five or more studies could be pooled, random-effects meta-analysis was used, otherwise common-effects meta-analysis was used. Risk of bias was evaluated with Cochrane tools. This study was registered with PROSPERO, CRD42022352502. A total of 62 studies (n=9253) were included reporting on 45 different questionnaires. Twenty-seven studies were RCTs and 25 were observational studies. RCT meta-analyses showed reduced diabetes distress (standardised mean difference [95% CI]:-0.159 [-0.309,-0.010], I2=23.0%), reduced fear of hypoglycaemia (-0.339 [-0.566,-0.111], I2=42.6%), and improved hypoglycaemia unawareness (-0.231 [-0.424,-0.037], I2=0.0%), quality of life in adults (0.347 [0.134, 0.560], I2=0.0%) and children/adolescents (0.249 [0.050, 0.448], I2=0.0%). Observational meta-analyses corroborated improvements in diabetes distress (-0.217 [-0.403,-0.031], I2=68.5%), fear of hypoglycaemia (-0.445 [-0.540,-0.349], I2=0.0%), hypoglycaemia unawareness (-0.212 [-0.419,-0.004], I2=0.0%), and showed improved sleep quality (-0.158 [-0.255,-0.061], I2=0.0%). We found low to moderate effect sizes indicating that AID therapy is associated with reduced burden and improved well-being in people with diabetes. Evidence comes from both RCTs and observational studies. However, for some PROs only a limited number of studies could be pooled with a large heterogeneity in questionnaires used. More research is needed with a more uniformed assessment of PROs to demonstrate the added value of AID therapy on psychosocial outcomes. None.

Real-world performance of the omnipod® 5 automated insulin delivery system in &gt;6,600 children, adolescents, and young adults with type 1 diabetes in the united kingdom

Real-world performance of the omnipod^® 5 automated insulin delivery system in &gt;6,600 children, adolescents, and young adults with type 1 diabetes in the united kingdom

Automating insulin delivery through pump and continuous glucose monitoring connectivity: Maximizing opportunities to improve outcomes.

The development of automated insulin delivery (AID) systems, which connect continuous glucose monitoring (CGM) systems with algorithmic insulin delivery from an insulin pump (continuous subcutaneous insulin infusion, [CSII]), has led to improved glycaemia and quality of life benefits in those with insulin-treated diabetes. This review summarizes the benefits gained by the connectivity between insulin pumps and CGM devices. It details the technical requirements and advances that have enabled this, and highlights the clinical and user benefits of such systems. Clinical trials and real-world outcomes from the use of AID systems in people with type 1 diabetes (T1D)will be the focus of this article; outcomes in people with type 2 diabetes (T2D) and other diabetes subtypes will also be discussed. We also detail the limitations of current technological approaches for connectivity between insulin pumps and CGM devices. While recognizing the barriers, we discuss opportunities for the future.

The Supporting Emerging Adults With Diabetes (SEAD) Program: An Adult-Based Real-World Clinical Model That Improves Hospitalizations, Diabetes Technology Uptake, and Glycemic Outcomes in Underserved Young Adults With Type 1 Diabetes.

Underserved young adults (YA) with type 1 diabetes (T1D) experience the worst outcomes across the life span. We developed and integrated the Supporting Emerging Adults with Diabetes (SEAD) program into routine endocrinology care to address unmet social and medical challenges. This study was designed as a longitudinal cohort study, with prospective data collection over 4 years on YA in SEAD compared with usual endocrine care. We used propensity-weighted analysis to account for differences in baseline characteristics, and multivariate regression and Cox proportional hazard models to evaluate change in outcomes over time. Primary outcomes included incidence of hospitalizations, diabetes technology uptake, and annual change in HbA1c levels. We included 497 YA with T1D in SEAD (n = 332) and usual endocrine care (n = 165); mean age 25 years, 27% non-Hispanic Black, 46% Hispanic, 49% public insurance, mean HbA1c 9.2%. Comparing YA in SEAD versus usual care, 1) incidence of hospitalizations was reduced by 64% for baseline HbA1c >9% (HR 0.36 [0.13, 0.98]) and 74% for publicly insured (HR 0.26 [0.07, 0.90]); 2) automated insulin delivery uptake was 1.5-times higher (HR 1.51 [0.83, 2.77]); and 3) HbA1c improvement was greater (SEAD, -0.37% per year [-0.59, -0.15]; usual care, -0.26% per year [-0.58, 0.05]). SEAD meaningfully improves clinical outcomes in underserved YA with T1D, especially for publicly insured and high baseline HbA1c levels. Early intervention for at-risk YA with T1D as they enter adult care could reduce inequity in short and long-term outcomes.

SARS-CoV-2 booster vaccination does not worsen glycemia in people with type 1 diabetes using insulin pumps: an observational study.

Despite an increased risk for adverse outcomes from SARS-CoV-2 infection among individuals with type 1 diabetes (T1D), vaccine hesitancy persists due to safety concerns including dysglycemia. The impact of booster vaccination on individuals using automated insulin delivery (AID) systems remains unclear. We used continuous glucose monitoring (CGM) data from 53 individuals with T1D using insulin pump therapy who received their third and/or fourth COVID-19 vaccination. CGM data from the 14 days before and 3 and 7 days after each vaccination were compared. The primary outcome was glucose time in range (TIR) (70-180mg/dL) 3 and 7 days post-vaccination compared with the 14 days prior. Secondary outcomes included other CGM metrics such as time below range (< 70mg/dL), time above range (> 180mg/dL), mean glucose, co-efficient of variation and average total daily insulin. The cohort comprised 53 adults (64% women, 64% AID), totaling 74 vaccination periods (84% Pfizer-BioNTech boosters), mean ± SD age 40.0 ± 15.9 years, duration of diabetes 26.0 ± 15.4 years. There was no significant difference between pre-vaccination TIR (61.0%±18.5) versus 3 (60.5%±22.8) and 7 days post-vaccination (60.2%±21.8; p = 0.79). Level 1 hypoglycemia, time in range 54-69mg/dL, was lower 3 (1.1%±1.7) and 7 days post-vaccination (1.1%±1.6), compared with 14 days pre-vaccination (1.4%±1.4; p = 0.021). The study provides evidence that SARS-CoV-2 booster vaccination does not acutely worsen glycemia in people with T1D receiving insulin pump therapy.