Hypoglycemia and Hyperglycemia According to Type of Diabetes: Observations During Fully Closed-Loop Insulin Delivery in Adults With Type 1 and Type 2 Diabetes.

BACKGROUND: CamAPS HX fully closed-loop (FCL) system, with no user input required at mealtimes, has been shown to be safe and effective in adults with type 1 and type 2 diabetes. We assessed whether time spent in hypoglycemia and hyperglycemia during FCL insulin delivery in adults varied by type of diabetes over the 24-hour period. METHODS: We retrospectively analyzed eight weeks of data from 52 participants (adults with type 1 diabetes and adults with insulin-treated type 2 diabetes) recruited to two single-center randomized controlled studies using FCL insulin delivery during unrestricted-living conditions. Key outcomes were time spent in hypoglycemia <70 mg/dL and marked hyperglycemia >300 mg/dL by type of diabetes. RESULTS: The median percentage of time spent in hypoglycemia <70 mg/dL over the 24-hour period was lower for those with type 2 diabetes than for those with type 1 diabetes (median [interquartile range (IQR)] 0.43% [0.20-0.77] vs 0.86%, [0.54-1.46]; mean difference 0.46 percentage points [95% CI 0.23-0.70]; P < .001). Median percentage time in marked hyperglycemia >300 mg/dL was lower for those with type 2 diabetes than for those with type 1 diabetes (median [IQR] 1.8% [0.6-3.5] vs 9.3% [6.9-11.8]; mean difference 7.8 percentage points [95% CI 5.5-10.0]; P < .001). CONCLUSIONS: Using the FCL system, hypoglycemia and marked hyperglycemia exposure were lower in type 2 diabetes than in type 1 diabetes.

Hybrid Closed-Loop with Faster Insulin Aspart Compared with Standard Insulin Aspart in Very Young Children with Type 1 Diabetes: A Double-Blind, Multicenter, Randomized, Crossover Study.

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 3.9-10.0 mmol/L. We randomized 25 participants: mean (±standard deviation) age 5.1 ± 1.3 years, baseline HbA1c 55 ± 9 mmol/mol. Time in range was not significantly different between interventions (64% ± 9% vs. 65% ± 9% for HCL with Fiasp vs. IAsp; mean difference -0.33% [95% confidence interval: -2.13 to 1.47; P = 0.71]). There was no significant difference in time with glucose <3.9 mmol/L. No post-randomization severe hypoglycemia or diabetic ketoacidosis events occurred. Use of Fiasp with CamAPS FX HCL demonstrated no significant difference in glycemic outcomes compared with IAsp in very young children with T1D. Clinical trials registration: NCT04759144.

Fully automated closed-loop insulin delivery in adults with type 2 diabetes: an open-label, single-center, randomized crossover trial.

In adults with type 2 diabetes, the benefits of fully closed-loop insulin delivery, which does not require meal bolusing, are unclear. In an open-label, single-center, randomized crossover study, 26 adults with type 2 diabetes (7 women and 19 men; (mean ± s.d.) age, 59 ± 11 years; baseline glycated hemoglobin (HbA1c), 75 ± 15 mmol mol-1 (9.0% ± 1.4%)) underwent two 8-week periods to compare the CamAPS HX fully closed-loop app with standard insulin therapy and a masked glucose sensor (control) in random order, with a 2-week to 4-week washout between periods. The primary endpoint was proportion of time in target glucose range (3.9-10.0 mmol l-1). Analysis was by intention to treat. Thirty participants were recruited between 16 December 2020 and 24 November 2021, of whom 28 were randomized to two groups (14 to closed-loop therapy first and 14 to control therapy first). Proportion of time in target glucose range (mean ± s.d.) was 66.3% ± 14.9% with closed-loop therapy versus 32.3% ± 24.7% with control therapy (mean difference, 35.3 percentage points; 95% confidence interval (CI), 28.0-42.6 percentage points; P < 0.001). Time > 10.0 mmol l-1 was 33.2% ± 14.8% with closed-loop therapy versus 67.0% ± 25.2% with control therapy (mean difference, -35.2 percentage points; 95% CI, -42.8 to -27.5 percentage points; P < 0.001). Mean glucose was lower during the closed-loop therapy period than during the control therapy period (9.2 ± 1.2 mmol l-1 versus 12.6 ± 3.0 mmol l-1, respectively; mean difference, -3.6 mmol l-1; 95% CI, -4.6 to -2.5 mmol l-1; P < 0.001). HbA1c was lower following closed-loop therapy (57 ± 9 mmol mol-1 (7.3% ± 0.8%)) than following control therapy (72 ± 13 mmol mol-1 (8.7% ± 1.2%); mean difference, -15 mmol mol-1; 95% CI, -11 to -20 mmol l-1 (mean difference, -1.4%; 95% CI, -1.0 to -1.8%); P < 0.001). Time < 3.9 mmol l-1 was similar between treatments (a median of 0.44% (interquartile range, 0.19-0.81%) during the closed-loop therapy period versus a median of 0.08% (interquartile range, 0.00-1.05%) during the control therapy period; P = 0.43). No severe hypoglycemia events occurred in either period. One treatment-related serious adverse event occurred during the closed-loop therapy period. Fully closed-loop insulin delivery improved glucose control without increasing hypoglycemia compared with standard insulin therapy and may represent a safe and efficacious method to improve outcomes in adults with type 2 diabetes. This study is registered with ClinicalTrials.gov (NCT04701424).