4.4 Article

The Insulin-Only Bionic Pancreas Pivotal Trial Extension Study: A Multi-Center Single-Arm Evaluation of the Insulin-Only Configuration of the Bionic Pancreas in Adults and Youth with Type 1 Diabetes

期刊

DIABETES TECHNOLOGY & THERAPEUTICS
卷 24, 期 10, 页码 726-736

出版社

MARY ANN LIEBERT, INC
DOI: 10.1089/dia.2022.0341

关键词

bionic pancreas; type 1 diabetes; adults; pediatrics; artificial pancreas; evaluation; automated insulin delivery

资金

  1. National Institute of Diabetes and Digestive and Kidney Diseases [1UC4DK108612-01]
  2. Beta Bionics, Inc.
  3. Novo Nordisk

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This study evaluated the effectiveness of transitioning from standard-of-care management to insulin-only configuration of the iLet bionic pancreas in patients with type 1 diabetes. The results showed that glycemic control improved, with a decrease in HbA1c levels and an increase in time spent within the target range.
Objective: To evaluate a transition from standard-of-care (SC) management of type 1 diabetes (any insulin delivery method including hybrid closed-loop systems plus real-time continuous glucose monitoring [CGM]) to use of the insulin-only configuration of the iLet((R)) bionic pancreas (BP) in 90 adults and children (age 6-71 years). Research Design and Methods: After the SC group completed the randomized controlled trial (RCT) portion of the Insulin-Only BP Pivotal Trial, 90 of the 107 participants participated in a 13-week study using the BP. The key outcomes were change from baseline in HbA1c and CGM metrics after 13 weeks on the BP. Results: Using the BP, mean HbA1c decreased from 7.7%1.0% (6110.9mmol/mol) at baseline to 7.1%+/- 0.6% (54 +/- 6.6mmol/mol) at 13 weeks (mean change -0.55%+/- 0.72% [-6 +/- 7.9mmol/mol], P<0.001), time in range 70-180mg/dL increased by 12.0%+/- 12.5% (from 53%+/- 17% to 65%+/- 9%, P<0.001), and mean glucose decreased by -18 +/- 23mg/dL (from 182 +/- 32 to 164 +/- 15mg/dL, P<0.001). The higher the baseline HbA1c level, the greater the change in HbA1c. Results were similar in the adult (N=42) and pediatric (N=48) cohorts. Time <70mg/dL decreased from baseline over the 13 weeks by -0.50%+/- 1.86% (P=0.02), and time <54mg/dL was similar (change from baseline -0.08%+/- 0.59%, P=0.24). Two severe hypoglycemia events (in same participant) and one diabetic ketoacidosis event occurred. Conclusions: Glycemic control improved after adult and pediatric participants in the SC arm in the Insulin-Only BP Pivotal Trial transitioned to use of the BP. Improvement using the BP was of similar magnitude to that observed during the RCT.

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