Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2023 Oct;25(10):705-717.
doi: 10.1089/dia.2023.0238. Epub 2023 Sep 5.

Psychosocial Impact of the Insulin-Only iLet Bionic Pancreas for Adults, Youth, and Caregivers of Youth with Type 1 Diabetes

Jill Weissberg-Benchell  1 , Anthony T Vesco  1 , Jenna Shapiro  1 , Peter Calhoun  2 , Edward R Damiano  3   4 , Steven J Russell  4 , Zoey Li  2 , Firas H El-Khatib  4 , Katrina J Ruedy  2 , Courtney A Balliro  4 , Roy W Beck  2
Affiliations
Randomized Controlled Trial

Psychosocial Impact of the Insulin-Only iLet Bionic Pancreas for Adults, Youth, and Caregivers of Youth with Type 1 Diabetes

Jill Weissberg-Benchell et al. Diabetes Technol Ther. 2023 Oct.

Abstract

Objective: To evaluate the psychosocial impact and user experience for the insulin-only configuration of iLet bionic pancreas (BP) in persons 6-83 years years of age with type 1 diabetes. Research Design and Methods: In this multicenter, randomized controlled, 13-week trial, 275 adults (221 randomly assigned to the BP group and 54 to the standard of care [SC] group) and 165 youth and their caregivers (112 randomly assigned to the BP group and 53 to the SC group) completed psychosocial questionnaires at baseline, mid-study, and the end of the trial. Results: In all age groups, most participants would recommend using the BP, including those with previous experience using automated insulin delivery devices. Similarly, the vast majority of participants reported a high level of perceived benefits and a low number of perceived burdens. Adult participants reported significant decreases in the fear of hypoglycemia and in diabetes-specific emotional distress, as well as improvements in their perceived well-being. Conclusion: Findings demonstrate acceptability, reduced burden, and positive psychosocial outcomes for adults. Children and teenagers also report high acceptability and reduced burden, but less clear improvements in psychosocial outcomes. Clinical Trial Registration Number: NCT04200313.

Keywords: Automated insulin delivery; Bionic pancreas; Patient-reported outcomes; Psychosocial; Type 1 diabetes.

PubMed Disclaimer

Conflict of interest statement

J.W.-B. reports consulting payments from Beta Bionics. A.T.V. has no personal financial disclosures. J.S. has no personal financial disclosure. P.C. is a former Dexcom employee, and his current employer has received consulting payments on his behalf from vTv Therapeutics, Beta Bionics, Dexcom, and Diasome. E.R.D. has issued patents and pending patents on aspects of bionic pancreas, and is an employee, the Executive Chair of the Board of Directors, and shareholder of Beta Bionics. S.J.R. has issued patents and pending patents on aspects of 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 that was bought out by Medtronic, has received consulting fees from Beta Bionics, Novo Nordisk, Senseonics, and Flexion Therapeutics, has received grant support from Zealand Pharma, Novo Nordisk, and Beta Bionics, and has received in-kind support in the form of technical support and/or donation of materials from Zealand Pharma, Ascencia, Senseonics, Adocia, and Tandem Diabetes. Z.L. has no personal financial disclosure, but reports that her employer has received grant support from Beta Bionics, Dexcom, and Tandem Diabetes Care. F.H.E.-K. has issued patents and pending patents on aspects of bionic pancreas and is an employee and shareholder of Beta Bionics. K.J.R. has no personal financial disclosure, but reports that her employer has received grant support from Beta Bionics, Dexcom, and Tandem Diabetes Care. C.A.B. reports receiving consulting payments from Beta Bionics, Novo Nordisk, and Zealand Pharma. R.W.B. reports no personal financial disclosure, but reports that his institution has received funding on his behalf as follows: grant funding and study supplies from Tandem Diabetes Care, Beta Bionics, 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.

References

    1. Bekiari E, Kitsios K, Thabit H, et al. . Artificial pancreas treatment for outpatients with type 1 diabetes: Systematic review and meta-analysis. BMJ 2018;361:k1310; doi: 10.1136/bmj.k1310 - DOI - PMC - PubMed
    1. Adams RN, Tanenbaum ML, Hanes SJ, et al. . Psychosocial and human factors during a trial of a AIDAID system for type 1 diabetes management. Diabetes Technol Ther 2018;20(10):648–653; doi: 10.1089/dia.2018.0174 - DOI - PubMed
    1. Bisio A, Brown SA, McFadden R, et al. . Sleep and diabetes-specific psycho-behavioral outcomes of a new automated insulin delivery system in young children with type 1 diabetes and their parents. Pediatr Diabetes 2021;22(3):495–502; doi: 10.1111/pedi.13164 - DOI - PubMed
    1. Bisio A, Gonder-Frederick L, McFadden R, et al. . The impact of a recently approved automated insulin delivery system on glycemic, sleep, and psychosocial outcomes in older adults with type 1 diabetes: A pilot study. J Diabetes Sci Technol 2022;16(3):663–669; doi: 10.1177/1932296820986879 - DOI - PMC - PubMed
    1. Kudva YC, Laffel LM, Brown SA, et al. . Patient-reported outcomes in a randomized trial of closed-loop control: The pivotal international diabetes closed-loop trial. Diabetes Technol Ther 2021;23(10):673–683; doi: 10.1089/dia.2021.0089 - DOI - PMC - PubMed

Publication types

Associated data