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
Clinical Trial
. 2022 May;16(3):663-669.
doi: 10.1177/1932296820986879. Epub 2021 Jan 15.

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

Alessandro Bisio  1 , Linda Gonder-Frederick  1   2 , Ryan McFadden  1 , Daniel Cherñavvsky  1 , Mary Voelmle  1   3 , Michael Pajewski  1 , Pearl Yu  4 , Heather Bonner  4 , Sue A Brown  1   3
Affiliations
Clinical Trial

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

Alessandro Bisio et al. J Diabetes Sci Technol. 2022 May.

Abstract

Background: Older adults with type 1 diabetes (≥65 years) are often under-represented in clinical trials of automated insulin delivery (AID) systems. We sought to test the efficacy of a recently FDA-approved AID system in this population.

Methods: Participants with type 1 diabetes used sensor-augmented pump (SAP) therapy for four weeks and then used an AID system (Control-IQ) for four weeks. In addition to glucose control variables, patient-reported outcomes (PRO) were assessed with questionnaires and sleep parameters were assessed by actigraphy.

Results: Fifteen older adults (mean age 68.7 ± 3.3, HbA1c of 7.0 ± 0.8) completed the pilot trial. Glycemic outcomes improved during AID compared to SAP. During AID use, mean glucose was 146.0 mg/dL; mean percent time in range (TIR, 70-180 mg/dL) was 79.6%; median time below 70 mg/dL was 1.1%. The AID system was in use 92.6% ± 7.0% of the time. Compared to SAP, while participants were on AID the TIR increased significantly (+10%, P = .002) accompanied by a reduction in both time above 180 mg/dL (-6.9%, P = .005) and below 70 mg/dl (-0.4%, P = .053). Diabetes-related distress decreased significantly while using AID (P = .028), but sleep parameters remained unchanged.

Conclusions: Use of this AID system in older adults improved glycemic control with high scores in ease of use, trust, and usability. Participants reported an improvement in diabetes distress with AID use. There were no significant changes in sleep.

Keywords: artificial pancreas; automated insulin delivery; closed-loop control; continuous glucose monitoring; continuous subcutaneous insulin infusion; sensor-augmented pump therapy.

PubMed Disclaimer

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: This study was funded by a grant from the Virginia Research Investment Fund and received study supplies from Tandem Diabetes Care and Dexcom.

SAB reports grants from Virginia Research Investment Fund, non-financial support from Tandem Diabetes Care, non-financial support from Dexcom during the conduct of the study; grants and non-financial support from Tandem Diabetes Care, non-financial support from Dexcom, non-financial support from Roche Diagnostics, grants from Insulet, grants from Tolerion, outside the submitted work.

RM and AB report grants from Virginia Research Investment Fund, non-financial support from Dexcom Inc., non-financial support from Tandem Diabetes Care, during the conduct of the study.

MV reports grants from DexCom Medtronic, Insulet, and Tolerion outside the submitted work.

DRC was a part-time assistant professor of the UVA-CDT when the trial was in progress; now he is a full-time Dexcom employee affiliated with the UVA-CDT as an adjunct professor. DRC reports grants from State Council of Higher Education for Virginia (Virginia Research Investment Fund), during the conduct of the study.

LGF reports grants from Virginia Research Investment Fund, non-financial support from Dexcom Inc., non-financial support from Tandem Diabetes Care, during the conduct of the study. LGF has been licensed by the University of Virginia to form an LLC in partnership with the university to distribute and change licensing costs for the use of the Hypoglycemia Fear Survey in studies conducted by for-profit entities including pharmaceutical companies. However, there were no licensing fees involved for the use of the survey in this study. The survey is always available to use free of costs to non-profit entities.

PY, HB, and MP have nothing to disclose.

Figures

Figure 1.
Figure 1.
Study Design.
See this image and copyright information in PMC

References

    1. Vaportzis E, Clausen MG, Gow AJ. Older adults perceptions of technology and barriers to interacting with tablet computers: a focus group study. Front Psychol. 2017;8:1-11. - PMC - PubMed
    1. Fischer SH, David D, Crotty BH, Dierks M, Safran C. Acceptance and use of health information technology by community-dwelling elders. Int J Med Inform. 2014;83(9):624-635. - PMC - PubMed
    1. Volčanšek Š, Lunder M, Jane A. Acceptability of continuous glucose monitoring in elderly diabetes patients using multiple daily insulin injections. Diabetes Technol Ther. 2019;21(10):557-565. - PubMed
    1. Olson KE, O’Brien MA, Rogers WA, Charness N. Diffusion of technology: frequency of use for younger and older adults. Ageing Int. 2011;36(1):123-145. - PMC - PubMed
    1. Bergenstal RM, Garg S, Weinzimer SA, et al.. Safety of a hybrid closed-loop insulin delivery system in patientswith type 1 diabetes. JAMA. 2016;316(13):1407-1408. - PubMed

Publication types