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Randomized Controlled Trial
. 2023 Jun 1;46(6):1185-1190.
doi: 10.2337/dc22-1478.

The Insulin-Only Bionic Pancreas Improves Glycemic Control in Non-Hispanic White and Minority Adults and Children With Type 1 Diabetes

Luz E Castellanos  1 , Steven J Russell  2 , Edward R Damiano  2   3 , Roy W Beck  4 , Viral N Shah  5 , Ryan Bailey  4 , Peter Calhoun  4 , Keisha Bird  6 , Nelly Mauras  6 ; Bionic Pancreas Research Group
Collaborators, Affiliations
Randomized Controlled Trial

The Insulin-Only Bionic Pancreas Improves Glycemic Control in Non-Hispanic White and Minority Adults and Children With Type 1 Diabetes

Luz E Castellanos et al. Diabetes Care. .

Abstract

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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Conflict of interest statement

Duality of Interest. This study received funding support from Beta Bionics, Inc. S.J.R. has issued patents and pending patents on aspects of the bionic pancreas that are assigned to Massachusetts General Hospital and licensed to Beta Bionics; has received honoraria and/or travel expenses for lectures from Novo Nordisk, Roche, and Ascensia; serves on the scientific advisory boards of Unomedical; served on scientific advisory board and had stock in Companion Medical, which was bought out by Medtronic; has received consulting fees from Beta Bionics, Inc., Novo Nordisk, Senseonics, and Flexion Therapeutics; has received grant support from Zealand Pharma, Novo Nordisk, and Beta Bionics, Inc.; and has received in-kind support in the form of technical support and/or donation of materials from Zealand Pharma, Ascensia, Senseonics, Adocia, and Tandem Diabetes. While this manuscript was under review, S.J.R. became an employee of Beta Bionics, Inc. E.R.D has issued patents and pending patents on aspects of the bionic pancreas and is an employee, is the Executive Chair of the Board of Directors, and a shareholder of Beta Bionics, Inc. V.N.S.’s employer, University of Colorado, received research support from Novo Nordisk, Eli Lilly, Insulet, Dexcom, Tandem Diabetes Care, Jaeb Center for Health Research, the National Institutes of Health, and JDRF. V.N.S. also received honoraria through CU Medicine from Medscape and LifeScan for advisory boards and from Dexcom and Insulet for consulting and speaking. P.C. is a former Dexcom employee and his current employer has received consulting payments on his behalf from vTv Therapeutics, Beta Bionics, Inc., Dexcom, and Diasome. R.W.B. reports that his institution has received funding on his behalf as follows: grant funding and study supplies from Tandem Diabetes Care, Beta Bionics, Inc., and Dexcom; study supplies from Medtronic, Ascencia, and Roche; consulting fees and study supplies from Eli Lilly and Novo Nordisk; and consulting fees from Insulet, Bigfoot Biomedical, vTv Therapeutics, and Diasome. N.M. has received research grant support through her institution from Novo Nordisk and grant funding and study supplies from Medtronic and LifeScan, and through subcontracts with the Jaeb coordinating center from Beta Bionics, Inc., Eli Lilly, Ascencia, and Dexcom. No other potential conflicts of interest relevant to this article were reported.

Figures

None
Graphical abstract
Figure 1
Figure 1
HbA1c change from baseline by race/ethnicity and treatment group. A: Overall change in HbA1c from baseline to week 13 in White and Minority participants. B: Change in HbA1c from baseline to week 13 in White and Minority participants with baseline HbA1c <8%. C: Change in HbA1c from baseline to week 13 in White and Minority participants with baseline HbA1c ≥8%. Black dots indicate the mean values, horizontal bars in the boxes indicate the medians, and the bottom and top of each box represent the 25th and 75th percentiles, respectively.
Figure 2
Figure 2
Distribution of HbA1c at baseline and follow-up by race and treatment. HbA1c data are shown at baseline and at 13 weeks for White and Minority participants in the BP groups (A and B) and SC groups (C and D). The curves represent the distribution of HbA1c at baseline and week 13, with higher density values (measured from the area under the curve) representing a greater proportion of individuals with a given HbA1c. The vertical lines represent the mean values, which are indicated numerically at the top of each line.
See this image and copyright information in PMC

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