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Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks and destroys the insulin-producing beta cells in the pancreas. As a result, the body is unable to produce sufficient insulin, and individuals with...
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Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes.

, Steven J Russell1, Roy W Beck1

  • 1The authors' affiliations are as follows: the Diabetes Research Center, Massachusetts General Hospital (S.J.R., C.A.B., J.S.S., L.E.C., M.A.H., M.T., M.S.P., M.Y.S.), and Boston University (E.R.D.), Boston, and Beta Bionics, Concord (E.R.D., F.H.E.-K.) - all in Massachusetts; the Jaeb Center for Health Research, Tampa (R.W.B., K.J.R., Z.L., P.C.), and Nemours Children's Health Jacksonville, Jacksonville (N.M., M. Benson, K. Bird, K.E., J. Permuy) - both in Florida; the Barbara Davis Center for Diabetes, University of Colorado, Aurora (R.P.W., G.F., R.S., L.H.M., E.C., V.N.S., S.P.); Stanford University School of Medicine, Palo Alto (B.B., R.L., L.E., M.S.H., M. Basina), Children's Hospital of Orange County, Orange (M.D., A. Bhangoo, N.F., H.K., F.S.), and the University of California, San Diego, La Jolla (J. Pettus, S.B.) - all in California; Cleveland Clinic, Cleveland (K.Z., B.H., L.O.); University of Texas Southwestern Medical Center, Dallas (P.R., P.C.W., A. Choudhary, J. Penn), and University of Texas Health Science Center, San Antonio (J.L., R.J., M.R., E.E., C.K., R.F.-P.); the University of Washington, Seattle (I.B.H., S.T.); the Naomi Berrie Diabetes Center, Columbia University, New York (R.G., K.M.W., N.L.); the University of North Carolina, Chapel Hill (J.B.B., M.S.K., K. Bergamo, K.R.K., J.M.D., S. Machineni, L.A.Y., J.C.D.); the Henry Ford Health System, Detroit (D.K., A. Bhan, J.K.J.); Emory University, Atlanta (A.M., K.C., E.F.); Washington University in St. Louis, St. Louis (J.B.M., M.S., J.M.S., S.A., A. Cedeno); Children's National Hospital, Washington, DC (F.C., S. Meighan, A.D.); and the Pritzker Department of Psychiatry and Behavioral Health, Ann and Robert Lurie Children's Hospital, Chicago (J.W.-B.).

The New England Journal of Medicine
|September 28, 2022
PubMed
Summary

The bionic pancreas significantly lowered glycated hemoglobin levels in type 1 diabetes patients compared to standard care. This automated system simplifies insulin delivery without carbohydrate counting, improving glycemic control.

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Area of Science:

  • Endocrinology
  • Biomedical Engineering
  • Diabetes Technology

Background:

  • Current semi-automated insulin delivery systems require complex individualized regimens and carbohydrate counting.
  • The bionic pancreas offers autonomous insulin delivery, initialized by body weight and using meal announcements without carbohydrate counting.

Purpose of the Study:

  • To evaluate the efficacy and safety of the bionic pancreas compared to standard care in individuals with type 1 diabetes.
  • To assess the impact on glycated hemoglobin levels and time spent below a critical glucose threshold.

Main Methods:

  • A 13-week, multicenter, randomized trial comparing the bionic pancreas to standard care in participants aged 6 years and older with type 1 diabetes.
  • Primary outcome: glycated hemoglobin (HbA1c) at 13 weeks. Secondary outcome: time with glucose levels below 54 mg/dL.

Main Results:

  • The bionic pancreas group showed a significant reduction in HbA1c from 7.9% to 7.3% (mean difference -0.5%), versus no change in the standard care group (7.7%).
  • Time below 54 mg/dL did not significantly differ between groups, meeting noninferiority criteria.
  • Severe hypoglycemia rates were 17.7 events/100 participant-years for the bionic pancreas and 10.8 for standard care (P=0.39). No diabetic ketoacidosis occurred.

Conclusions:

  • The bionic pancreas demonstrated superior efficacy in reducing HbA1c levels compared to standard care in a diverse population with type 1 diabetes.
  • The system provides an autonomous, user-friendly alternative for diabetes management, simplifying insulin dosing.
  • Further research may explore long-term outcomes and safety profiles of automated insulin delivery systems.