Dataset Information

Improvements in Glycemic Control Achieved by Altering the t_max Setting in the iLet^® Bionic Pancreas When Using Fast-Acting Insulin Aspart: A Randomized Trial.

ABSTRACT:

Introduction

We investigated the safety of, and glucose control by, the insulin-only configuration of the iLet^® bionic pancreas delivering fast-acting insulin aspart (faster aspart), using the same insulin-dosing algorithm but different time to maximal serum drug concentration (t_max) settings, in adults with type 1 diabetes.

Methods

We performed a single-center, single-blinded, crossover (two 7-day treatment periods) escalation trial over three sequential cohorts. Participants from each cohort were randomized to a default t_max setting (t₆₅ [t_max = 65 min]) followed by a non-default t_max setting (t₅₀ [t_max = 50 min; cohort 1], t₄₀ [t_max = 40 min; cohort 2], t₃₀ [t_max = 30 min; cohort 3]), or vice versa, all with faster aspart. Each cohort randomized eight new participants if escalation-stopping criteria were not met in the previous cohort.

Results

Overall, 24 participants were randomized into three cohorts. Two participants discontinued treatment, one due to reported 'low blood glucose' during the first treatment period of cohort 3 (t₃₀). Mean time in low sensor glucose (< 54 mg/dl, primary endpoint) was < 1.0% for all t_max settings. Mean sensor glucose in cohorts 1 and 2 was significantly lower at non-default versus default t_max settings, with comparable insulin dosing. The mean time sensor glucose was in range (70-180 mg/dl) was > 70% for all cohorts, except the default t_max setting in cohort 1. No severe hypoglycemic episodes were reported. Furthermore, there were no clinically significant differences in adverse events between the groups.

Conclusion

There were no safety concerns with faster aspart in the iLet at non-default t_max settings. Improvements were observed in mean sensor glucose without increases in low sensor glucose at non-default t_max settings.

Trial registration

ClinicalTrials.gov, NCT03816761.

SUBMITTER: Russell SJ

PROVIDER: S-EPMC8266971 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe safety and effectiveness of automated glycemic management have not been tested in multiday studies under unrestricted outpatient conditions.MethodsIn two random-order, crossover studies with similar but distinct designs, we compared glycemic control with a wearable, bihormonal, automated, "bionic" pancreas (bionic-pancreas period) with glycemic control with an insulin pump (control period) for 5 days in 20 adults and 32 adolescents with type 1 diabetes mellitus. The automatically adaptive algorithm of the bionic pancreas received data from a continuous glucose monitor to control subcutaneous delivery of insulin and glucagon.ResultsAmong the adults, the mean plasma glucose level over the 5-day bionic-pancreas period was 138 mg per deciliter (7.7 mmol per liter), and the mean percentage of time with a low glucose level (<70 mg per deciliter [3.9 mmol per liter]) was 4.8%. After 1 day of automatic adaptation by the bionic pancreas, the mean (±SD) glucose level on continuous monitoring was lower than the mean level during the control period (133±13 vs. 159±30 mg per deciliter [7.4±0.7 vs. 8.8±1.7 mmol per liter], P<0.001) and the percentage of time with a low glucose reading was lower (4.1% vs. 7.3%, P=0.01). Among the adolescents, the mean plasma glucose level was also lower during the bionic-pancreas period than during the control period (138±18 vs. 157±27 mg per deciliter [7.7±1.0 vs. 8.7±1.5 mmol per liter], P=0.004), but the percentage of time with a low plasma glucose reading was similar during the two periods (6.1% and 7.6%, respectively; P=0.23). The mean frequency of interventions for hypoglycemia among the adolescents was lower during the bionic-pancreas period than during the control period (one per 1.6 days vs. one per 0.8 days, P<0.001).ConclusionsAs compared with an insulin pump, a wearable, automated, bihormonal, bionic pancreas improved mean glycemic levels, with less frequent hypoglycemic episodes, among both adults and adolescents with type 1 diabetes mellitus. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; ClinicalTrials.gov numbers, NCT01762059 and NCT01833988.).

Project description:BackgroundCurrently available semiautomated insulin-delivery systems require individualized insulin regimens for the initialization of therapy and meal doses based on carbohydrate counting for routine operation. In contrast, the bionic pancreas is initialized only on the basis of body weight, makes all dose decisions and delivers insulin autonomously, and uses meal announcements without carbohydrate counting.MethodsIn this 13-week, multicenter, randomized trial, we randomly assigned in a 2:1 ratio persons at least 6 years of age with type 1 diabetes either to receive bionic pancreas treatment with insulin aspart or insulin lispro or to receive standard care (defined as any insulin-delivery method with unblinded, real-time continuous glucose monitoring). The primary outcome was the glycated hemoglobin level at 13 weeks. The key secondary outcome was the percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter; the prespecified noninferiority limit for this outcome was 1 percentage point. Safety was also assessed.ResultsA total of 219 participants 6 to 79 years of age were assigned to the bionic-pancreas group, and 107 to the standard-care group. The glycated hemoglobin level decreased from 7.9% to 7.3% in the bionic-pancreas group and did not change (was at 7.7% at both time points) in the standard-care group (mean adjusted difference at 13 weeks, -0.5 percentage points; 95% confidence interval [CI], -0.6 to -0.3; P<0.001). The percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter did not differ significantly between the two groups (13-week adjusted difference, 0.0 percentage points; 95% CI, -0.1 to 0.04; P<0.001 for noninferiority). The rate of severe hypoglycemia was 17.7 events per 100 participant-years in the bionic-pancreas group and 10.8 events per 100 participant-years in the standard-care group (P = 0.39). No episodes of diabetic ketoacidosis occurred in either group.ConclusionsIn this 13-week, randomized trial involving adults and children with type 1 diabetes, use of a bionic pancreas was associated with a greater reduction than standard care in the glycated hemoglobin level. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; ClinicalTrials.gov number, NCT04200313.).

Dataset Information

Improvements in Glycemic Control Achieved by Altering the t_max Setting in the iLet^® Bionic Pancreas When Using Fast-Acting Insulin Aspart: A Randomized Trial.

Introduction

Methods

Results

Conclusion

Trial registration

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Dataset Information

Improvements in Glycemic Control Achieved by Altering the tmax Setting in the iLet® Bionic Pancreas When Using Fast-Acting Insulin Aspart: A Randomized Trial.

Introduction

Methods

Results

Conclusion

Trial registration

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Improvements in Glycemic Control Achieved by Altering the t_max Setting in the iLet^® Bionic Pancreas When Using Fast-Acting Insulin Aspart: A Randomized Trial.