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Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes
Open accessAbstract
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 (31,63).”
From 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025 (2025) · cites this paper as [31]
In the citing paper
“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]
In the citing paper
“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]
In the citing paper
“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]
In the citing paper
“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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Citations
Cites
State of Type 1 Diabetes Management and Outcomes from the T1D Exchange in 2016–2018
Foster, N. C., Beck, R. W., Miller, K. M., Clements, M. A., Rickels, M. R., DiMeglio, L. A., Maahs, D. M., Tamborlane, W. V., Bergenstal, R., Smith, E., et al. (2019) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2018.0384 · Cited by 1,907
Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes
Brown, S. A., Kovatchev, B. P., Raghinaru, D., Lum, J. W., Buckingham, B. A., Kudva, Y. C., Laffel, L. M., Levy, C. J., Pinsker, J. E., Wadwa, R. P., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1907863 · Cited by 1,030
A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes
Breton, M. D., Kanapka, L. G., Beck, R. W., Ekhlaspour, L., Forlenza, G. P., Cengiz, E., Schoelwer, M., Ruedy, K. J., Jost, E., Carria, L., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa2004736 · Cited by 455
Pettus, J., Zhou, F. L., Shepherd, L. C., Preblick, R., Hunt, P. R., Paranjape, S., Miller, K. M., & Edelman, S. V. (2019) · Diabetes Care · doi:10.2337/dc19-0830 · Cited by 162
Accuracy of Carbohydrate Counting in Adults
Meade, L. T., & Rushton, W. E. (2016) · Clinical Diabetes · doi:10.2337/diaclin.34.3.142 · Cited by 71
Current Status and Emerging Options for Automated Insulin Delivery Systems
Forlenza, G. P., & Lal, R. (2022) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2021.0514 · Cited by 70
Bionic Pancreas Research Group, Messer, L. H., Buckingham, B. A., Cogen, F., Daniels, M., Forlenza, G., Jafri, R. Z., Mauras, N., Muir, A., Wadwa, R. P., et al. (2022) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2022.0201.pub · Cited by 59
Bionic Pancreas Research Group, Beck, R. W., Russell, S. J., Damiano, E. R., El-Khatib, F. H., Ruedy, K. J., Balliro, C., Li, Z., & Calhoun, P. (2022) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2022.0167 · Cited by 40
Bionic Pancreas Research Group, Kruger, D., Kass, A., Lonier, J., Pettus, J., Raskin, P., Salam, M., Trikudanathan, S., Zhou, K., Russell, S. J., et al. (2022) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2022.0200 · Cited by 38
Self-citationKanapka, L. G., Lum, J. W., & Beck, R. W. (2022) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2021.0548 · Cited by 35
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9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025
American Diabetes Association Professional Practice Committee, ElSayed, N. A., McCoy, R. G., Aleppo, G., Bajaj, M., Balapattabi, K., Beverly, E. A., Briggs Early, K., Bruemmer, D., Echouffo-Tcheugui, J. B., et al. (2025) · Diabetes Care · doi:10.2337/dc25-s009 · Cited by 728
9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2024
American Diabetes Association Professional Practice Committee, ElSayed, N. A., Aleppo, G., Bannuru, R. R., Bruemmer, D., Collins, B. S., Ekhlaspour, L., Gaglia, J. L., Hilliard, M. E., Johnson, E. L., et al. (2024) · Diabetes Care · doi:10.2337/dc24-s009 · Cited by 662
7. Diabetes Technology: Standards of Care in Diabetes—2025
American Diabetes Association Professional Practice Committee, ElSayed, N. A., McCoy, R. G., Aleppo, G., Balapattabi, K., Beverly, E. A., Briggs Early, K., Bruemmer, D., Echouffo-Tcheugui, J. B., Ekhlaspour, L., et al. (2025) · Diabetes Care · doi:10.2337/dc25-s007 · Cited by 348
7. Diabetes Technology: Standards of Care in Diabetes—2024
American Diabetes Association Professional Practice Committee, ElSayed, N. A., Aleppo, G., Bannuru, R. R., Bruemmer, D., Collins, B. S., Ekhlaspour, L., Hilliard, M. E., Johnson, E. L., Khunti, K., et al. (2024) · Diabetes Care · doi:10.2337/dc24-s007 · Cited by 281
Quattrin, T., Mastrandrea, L. D., & Walker, L. S. K. (2023) · The Lancet · doi:10.1016/s0140-6736(23)00223-4 · Cited by 292
Metadata
- 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
- 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
- bronze
- doi.org
- 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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