The insulin-only bionic pancreas improves glycemic control in non-Hispanic White and minority adults and children with type 1 diabetes
Open accessAbstract
OBJECTIVE: We evaluated the performance of the iLet bionic pancreas (BP) in non-Hispanic White individuals (here referred to as “Whites”) and in Black, Hispanic, and other individuals (here collectively referred to as “Minorities”). RESEARCH DESIGN AND METHODS: A multicenter, randomized controlled trial evaluated glycemic management with the BP versus standard of care (SC) in 161 adult and 165 pediatric participants with type 1 diabetes over 13 weeks. RESULTS: In Whites (n = 240), the mean baseline-adjusted difference in 13-week HbA1c between the BP and SC groups was −0.45% (95% CI −0.61 to −0.29 [−4.9 mmol/mol; −6.6 to −3.1]; P < 0.001), while this difference among Minorities (n = 84) was −0.53% (−0.83 to −0.24 [−6.0 mmol/mol; −9.2 to −2.8]; P < 0.001). In Whites, the mean baseline-adjusted difference in time in range between the BP and SC groups was 10% (95% CI 7–12; P < 0.001) and in Minorities was 14% (10–18; P < 0.001). CONCLUSIONS: The BP improves glycemic control in both Whites and Minorities and offers promise in decreasing health care disparities.
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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 [214]
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 [214]
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 [214]
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 [214]
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- Authors
- Castellanos, L. E., Russell, S. J., Damiano, E. R., Beck, R. W., Shah, V. N., Bailey, R., Calhoun, P., Bird, K., Mauras, N., Bionic Pancreas Research Group, Wadwa, R. P., Forlenza, G., Slover, R., Messer, L., Cobry, E., Shah, V., Polsky, S., Jost, E., Berget, C., Towers, L., Lange, S., Escobar, E., Beatson, C., Walker, S., Karami, A., Boranian, E., Buckingham, B., Lal, R., Ekhlaspour, L., Hughes, M. S., Basina, M., Hsu, L., Hatipoglu, B., Zhou, K., Olansky, L., Surckla, A., Lomeli, L., Isaacs, D., Knapp, S., Debs, A., Tomaro, T., Blanchette, J., Russell, S., Sherwood, J., Castellanos, L., Hillard, M., Tuffaha, M., Putman, M., Sands, M., Balliro, C., Greaux, E., Steiner, B., Gaston, S., Bartholomew, R., Martin, K., Daniels, M., Bhangoo, A., Forghani, N., Kashmiri, H., Sutton, F., Speer, H., Erickson, M., Thompson, S., McDaniel, A., Raskin, P., Strowig, S., Jordan, L., White, P., Choudhary, A., Penn, J., Henson, M., Molina, Y., Nwosu, C., Kumar, V., Burris, A., Jernigan, K., Mann, B., Lynch, J., Jafri, R., Rayas, M., Escaname, E., Kerr, C., Favela-Prezas, R., Olivarri, S., Pettus, J., Boeder, S., May, T., Armstrong, A., Giovanetti, E., Hirsch, I., Trikudanathan, S., Sanborn, N., Averkiou, X., Goland, R., Williams, K., Leibel, N., Hyatt, J., Pollak, S., Robinson, E., Casciano, E., Alvarez, A., Zagoren, E., Johnson, J., Sharma, S., Buse, J., Kirkman, M. S., Bergamo, K., Klein, K., Dostou, J., Machineni, S., Young, L., Diner, J., Kass, A., Purrington, V., Fraser, R., Uehling, J., Kruger, D., Bhan, A., Jones, J. K., Cushman, T., Hunter, H., Corker, N., Mukhashen, S., Mauras, N., Benson, M., Bird, K., Englert, K., Permuy, J., Ponthieux, K., Tarko, A., Muir, A., Ham, J. N., Cossen, K., Felner, E., Antich, A., Sanchez, W., Anzai, M., Lucas, K., Simpson, C., McGill, J., Salam, M., Silverstein, J., Adamson, S., Cedeno, A., Clifton, M. J., Schweiger, T., Bell, T., Cogen, F., Meighan, S., Dauber, A., Castro, M., McCarthy, T., Boucher, K., Jenkins, H., Weissberg-Benchell, J., Ruedy, K., Beck, R., Borgman, S., Bradshaw, S., Miller, P., Li, Z., Calhoun, P., Marek, M., Pritchard, R., Dolzhenko, E., Damiano, E. R., El-Khatib, F. H., Gabrielson, D., Idzorek, J., Elstrom-Park, A., Arreaza-Rubin, G., Eggerman, T., Green, N., Belle, S. H., Castle, J., Green, J., Legault, L., Willi, S. M., & Wysham, C.
- Affiliations
- 1Massachusetts General Hospital, Boston, MA
- 2Beta Bionics, Concord, MA
- 4Jaeb Center for Health Research, Tampa, FL
- 5Barbara Davis Center for Diabetes, University of Colorado, Aurora, CO
- Jaeb Center for Health Research (US)
- ORCID
- Russell, Steven J.
- Bailey, Ryan
- Wadwa, R. Paul
- Messer, Laurel
- Cobry, Erin
- Polsky, Sarit
- Jost, Emily
- Berget, Cari
- Lange, Samantha
- Beatson, Christie
- Buckingham, Bruce
- Lal, Rayhan
- Ekhlaspour, Laya
- Hughes, Michael S.
- Basina, Marina
- Zhou, Keren
- Lomeli, Laura
- Isaacs, Diana
- Blanchette, Julia
- Sherwood, Jordan
- Putman, Melissa
- Bartholomew, Rachel
- Daniels, Mark
- Bhangoo, Amrit
- White, Perrin
- Choudhary, Abha
- Jafri, Rabab
- Rayas, Maria
- Pettus, Jeremy
- Boeder, Schafer
- Hirsch, Irl
- Trikudanathan, Subbulaxmi
- Williams, Kristen
- Robinson, Elizabeth
- Buse, John
- Kirkman, M. Sue
- Klein, Klara
- Young, Laura
- Kruger, Davida
- Bhan, Arti
- Benson, Matthew
- Englert, Kimberly
- Muir, Andrew
- Ham, J. Nina
- Cossen, Kristina
- Felner, Eric
- McGill, Janet
- Salam, Maamoun
- Silverstein, Julie
- Adamson, Samantha
- Cogen, Fran
- Meighan, Seema
- Dauber, Andrew
- Weissberg-Benchell, Jill
- Li, Zoey
- Dolzhenko, Elizaveta
- Castle, Jessica
- Green, Jennifer
- Legault, Laurent
- Willi, Steven M.
- Wysham, Carol
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2023-03-31
- Volume
- 46
- Issue
- 6
- Pages
- 1185-1190
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- PMC
- PMC10234742
- OpenAlex
- W4362460280
- Cited by
- 11
- References
- 20
- Citations by year
- 2026: 3 · 2025: 3 · 2024: 1 · 2023: 4
- FWCI
- 2.26
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Diabetes Care (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Funders
- National Institute of Diabetes and Digestive and Kidney Diseases (1UC4DK108612-01)
- Beta Bionics, Inc
- Novo Nordisk
- Eli Lilly
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Surgery › Pancreatic function and diabetes
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Keywords
- type 1 diabetes, bionic pancreas, glycemic control, HbA1c, time in range, racial and ethnic minorities, health care disparities, type 1 diabetes in children, adults with type 1 diabetes
- MeSH terms
- Glycemic Control, Adult, Artificial Organs, Bionics, Blood Glucose, Child, Diabetes Mellitus, Type 1, Humans, Insulin, Minority Groups, Pancreas, White People
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