Diabetes Technology & Therapeutics

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Background It is unclear whether hybrid closed-loop therapy (HCL) attenuates the metabolic impact of missed or suboptimal meal insulin bolus compared with sensor-augmented pump therapy (SAP) in children with type 1 diabetes in free-living conditions. Methods This is an ancillary study from a multicenter randomized controlled trial that compared 24/7 HCL to evening and night (E/N) HCL for 36 weeks in children between 6 and 12 years old. In the present study, the 60 children from the E/N arm underwent a SAP phase, an evening and night (E/N) HCL for 18 weeks, then a 24/7 phase for 18 weeks, extended for 36 more weeks...

We evaluated the use of hybrid closed-loop (HCL) insulin delivery with faster insulin aspart (Fiasp) in very young children with type 1 diabetes (T1D). In a double-blind, multicenter, randomized, crossover study, children aged 2-6 years with T1D underwent two 8-week periods of HCL using CamAPS FX with Fiasp and standard insulin aspart (IAsp), in random order. Primary endpoint was between-treatment difference in time in target range 3.9-10.0mmol/L. We randomized 25 participants: mean(±SD) age 5.1±1...

The bionic pancreas (BP) is initialized with body weight only and doses insulin autonomously without carbohydrate counting, instead using qualitative meal announcements. In case of device malfunction, the BP generates and continuously updates back-up insulin doses for injection or pump users, including long-acting insulin dose, a four-period basal insulin profile, short-acting meal doses, and a glucose correction factor. Following a 13-week trial in type 1 diabetes, participants using the BP (6-83 years) completed 2-4 days in which they were randomly assigned to their pre-study insulin regimen (N=147) or to follow BP-provided guidance (N=148)...

Background: In recent years, continuous glucose monitor (CGM) use is increasing in people without diabetes to promote healthy lifestyle. CGM metrics such as glucose management indicator (GMI), a statistical formula to estimate glycated hemoglobin (HbA1c) from sensor glucose, is commonly used to approximate HbA1c. This study was aimed to evaluate discordance between GMI and HbA1c in people without diabetes. Methods: Children and nonpregnant adults (age ≥6 years) without diabetes (laboratory HbA1c <5...

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Insulin infusion site (IIS) failures are a weakness in insulin pump therapy. We examined experience with IIS failures among US individuals with diabetes on insulin pump via survey distributed to the T1D Exchange Online Community. Demographic factors, IIS characteristics, and diabetes-related perceptions were assessed by logistic regression to determine odds of higher (≥1 per month) or lower (<1 per month) reported IIS failure frequency. IIS failures were common; 41.4% reported ≥1 per month...

Aim: To assess long-term efficacy and safety of open-source automated insulin delivery (AID) in children and adults (7-70 years) with type 1 diabetes. Methods: Both arms of a 24-week randomized controlled trial comparing open-source AID (OpenAPS algorithm within a modified version of AndroidAPS, preproduction DANA-i™ insulin pump, Dexcom G6 continuous glucose monitor) with sensor-augmented pump therapy (SAPT), entered a 24-week continuation phase where the SAPT arm (termed SAPT-AID) crossed over to join the open-source AID arm (termed AID-AID)...

OBJECTIVE We evaluated the safety and feasibility of open-source automated insulin delivery AndroidAPS, in adolescents and young adults with type 1 diabetes (T1D) and compared its efficacy in three different scenarios: Hybrid Closed Loop with premeal boluses (HCL), Meal Announcement only (MA) and Full Closed Loop (FCL). RESEARCH DESIGN AND METHODS In an open-label, prospective, randomized crossover trial (clinicaltrials.gov NCT04835350), 16 adolescents with T1D (10 females) with mean age 17 years (range 15-20), HbA1c 56 mmol/mol (range 43-75) and mean duration of diabetes 5...

OBJECTIVE: To explore the impact of missing data on the accuracy of continuous glucose monitoring (CGM) metrics collected over a 2-week period in a clinical trial. RESEARCH DESIGN AND METHODS: Simulations were conducted to examine the effect of various patterns of missingness on the accuracy of CGM metrics as compared to a 'complete' dataset. The proportion of missing data, the 'block size' in which the data were missing, and the missing mechanism were modified for each 'scenario'...

Background: Estimation of insulin sensitivity (SI ) and its daily variation are key for optimizing insulin therapy in patients with type 1 diabetes (T1D). We recently developed a method for SI estimation from continuous glucose monitoring (CGM) and continuous subcutaneous insulin infusion (CSII) data in adults with T1D (SI SP ) and validated it under restrained experimental conditions. Herein, we validate in vivo a new version of SI SP performing well in daily life unrestrained conditions. Methods: The new SI SP was tested in both simulated and real data...

BACKGROUND: The aim of this multicenter observational real-world study was to investigate glycemic outcomes in children and adolescents with type 1 diabetes over the first six-month use of MiniMed™ 780G. Secondary objective was to evaluate demographic and clinical factors that may be significantly associated with the achievement of therapeutic goals. METHODS: Demographic, anamnestic, and clinical data of study participants were collected at time of enrolment...

OBJECTIVE: Use of continuous glucose measurement (CGM) systems and continuous subcutaneous insulin infusion (CSII) devices adhering to the skin can lead to skin reactions. The objective was to determine the prevalence and consequences of skin reactions to CGM or CSII infusion sites in a large, unbiased population. RESEARCH DESIGN AND METHODS: This is a cross-sectional, multicenter study. All adult patients with diabetes seen in consultation over a period of 7 months and using or having used a system with skin adhesives in the last 10 years were included and filled out a self-assessment questionnaire...

Automated insulin delivery (AID) may benefit individuals with long-standing type 1 diabetes where frequent exposure to hypoglycemia impairs counterregulatory responses. This study assessed the effect of 18 months AID on hypoglycemia avoidance and glucose counterregulatory responses to insulin-induced hypoglycemia in long-standing type 1 diabetes complicated by impaired awareness of hypoglycemia. Ten participants mean±SD age 49±16 and diabetes duration 34±16 years were initiated on AID. Continuous glucose monitoring was paired with actigraphy to assess awake and sleep-associated hypoglycemia exposure every 3 months...

We identified characteristics associated with continuous glucose monitoring (CGM) use in women of reproductive age with type 1 diabetes (T1D) in the T1D Exchange clinic registry from 2015 to 2018. Among 6643 assessed women, the frequency of CGM increased from 2015 to 2018 (20.6% vs. 30.0%; adjusted odds ratios [aOR]: 1.72; confidence interval [95% CI]: 1.51-1.95) and was more likely with recent pregnancy (45.3% vs. 25.8%; aOR: 1.63; 95% CI: 1.23-2.16). Non-Hispanic Black and Hispanic race and ethnicity, younger age, lower educational attainment, lower income, and Medicaid insurance were associated with lower odds of CGM...

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In an in-patient switch study, 10 adults with type 1 diabetes (T1D) performed 45-minutes of moderate intensity exercise on two occasions : 1) when using their usual insulin pump (UP) and 2) after transitioning to automated insulin delivery (AID) treatment (MiniMedTM 780G). Consensus glucose management guidelines for performing exercise were applied. Plasma glucose (PG) concentrations measured over a 3-hour monitoring period were stratified into time spent below (TBR [<3.9 mmol/L]) within (TIR [3.9-10.0 mmol/L]) and above (TAR [>10...

OBJECTIVE: To explore clinical consequences and potential root causes of insulin pump-associated adverse events (AEs) reported in the Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. RESEARCH DESIGN AND METHODS: Qualitative template analysis of narrative data in a 20% stratified random sample (n = 2,429) of reported AEs that occurred during the first six months of 2020 involving five insulin pump models marketed at that time: (1) MiniMed 670G, (2) MiniMed 630G, (3) Omnipod, (4) Omnipod DASH, and (5) t:slim X2...

Aim To analyse evaluate the efficacy, safety and satisfaction of the closed-loop system Accu-Chek Insight with Diabeloop™ (DBLG1) in adults with type 1 diabetes (T1D) in real-world conditions. Methods Patients with T1D using DBLG1 for at least 3 months were included. Glucometric parameters were analysed at baseline, 1, 2 and 3 months after starting DBLG1. HbA1c was measured before and at 3 months. Technical issues and acute complications were recorded and patients completed a satisfaction questionnaire...