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Multicenter, randomized trial of a bionic pancreas in type 1 diabetes

Open access
Bionic Pancreas Research Group·2022·New England Journal of Medicine
DOI 10.1056/nejmoa2205225PMC PMC10028490
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Abstract

BACKGROUND: Currently 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. METHODS: In 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. RESULTS: A 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. CONCLUSIONS: In 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.).

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  • With some AID systems, use of a simplified meal announcement method may be an alternative for prandial insulin dosing.

    “With some AID systems, use of a simplified meal announcement method may be an alternative for prandial insulin dosing (31,63).”

    From 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025 (2025) · cites this paper as [31]

  • AID use in pivotal trials consistently improved A1C.

    “with consistent improvement in A1C, increase in TIR, especially overnight, as well as reduction of time spent in hypoglycemia (207-219).”

    From 7. Diabetes Technology: Standards of Care in Diabetes—2025 (2025) · cites this paper as [215]

  • Across pivotal trials, AID systems in people aged 2 years and older, including older adults, were superior to standard insulin delivery/manual mode or SAP/usual care.

    “all AID system pivotal trials that examined individuals 2 years old or older, including older adults, have consistently demonstrated superiority to either standard insulin delivery (or manual mode for the single-arm studies) or SAP and/or usual care (for the randomized trials)”

    From 7. Diabetes Technology: Standards of Care in Diabetes—2025 (2025) · cites this paper as [215]

  • AID use in pivotal trials consistently increased TIR, especially overnight.

    “with consistent improvement in A1C, increase in TIR, especially overnight, as well as reduction of time spent in hypoglycemia (207-219).”

    From 7. Diabetes Technology: Standards of Care in Diabetes—2025 (2025) · cites this paper as [215]

  • AID use in pivotal trials reduced time spent in hypoglycemia.

    “with consistent improvement in A1C, increase in TIR, especially overnight, as well as reduction of time spent in hypoglycemia (207-219).”

    From 7. Diabetes Technology: Standards of Care in Diabetes—2025 (2025) · cites this paper as [215]

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Authors
Bionic Pancreas Research Group
Affiliations
Boston University (US)
Corresponding author
Bionic Pancreas Research Group
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2022-09-29
Volume
387
Issue
13
Pages
1161-1172
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa2205225
PMC
PMC10028490
OpenAlex
W4297519371
Cited by
216
References
10
Citations by year
2026: 41 · 2025: 63 · 2024: 55 · 2023: 50 · 2022: 7
FWCI
32.40
Type
journal article
Language
en
Open access
Licence
www.nejmgroup.org/legal/terms-of-use.htm (vor)
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
  • Digital Commons@Becker (Washington University School of Medicine) (submittedVersion)
  • eScholarship (California Digital Library) (submittedVersion)
Funders
  • National Institute of Diabetes and Digestive and Kidney Diseases (1UC4DK108612-01)
  • Beta Bionics, Inc
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
Keywords
bionic pancreas, type 1 diabetes, artificial pancreas, HbA1c, hypoglycemia, continuous glucose monitoring, insulin aspart, insulin lispro, non-inferiority, HbA1c reduction, diabetic ketoacidosis
MeSH terms
Adolescent, Adult, Aged, Bionics, Blood Glucose, Child, Diabetes Mellitus, Type 1, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Middle Aged, Blood Glucose Self-Monitoring, Young Adult, Insulin Aspart, Insulin Lispro

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