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Multicenter Study
. 2022 Aug:190:109998.
doi: 10.1016/j.diabres.2022.109998. Epub 2022 Jul 16.

How introduction of automated insulin delivery systems may influence psychosocial outcomes in adults with type 1 diabetes: Findings from the first investigation with the Omnipod® 5 System

William H Polonsky  1 , Korey K Hood  2 , Carol J Levy  3 , Sarah A MacLeish  4 , Irl B Hirsch  5 , Sue A Brown  6 , Bruce W Bode  7 , Anders L Carlson  8 , Viral N Shah  9 , Ruth S Weinstock  10 , Anuj Bhargava  11 , Thomas C Jones  12 , Grazia Aleppo  13 , Sanjeev N Mehta  14 , Lori M Laffel  14 , Gregory P Forlenza  9 , Jennifer L Sherr  15 , Lauren M Huyett  16 , Todd E Vienneau  16 , Trang T Ly  17 ; Omnipod 5 Research Group
Affiliations
Multicenter Study

How introduction of automated insulin delivery systems may influence psychosocial outcomes in adults with type 1 diabetes: Findings from the first investigation with the Omnipod® 5 System

William H Polonsky et al. Diabetes Res Clin Pract. 2022 Aug.

Abstract

Aims: To evaluate psychosocial outcomes for adults with type 1 diabetes (T1D) using the tubeless Omnipod® 5 Automated Insulin Delivery (AID) System.

Methods: A single-arm, multicenter (across the United States), prospective safety and efficacy study of the tubeless AID system included 115 adults with T1D. Participants aged 18-70 years completed questionnaires assessing psychosocial outcomes - diabetes distress (T1-DDS), hypoglycemic confidence (HCS), well-being (WHO-5), sleep quality (PSQI), insulin delivery satisfaction (IDSS), diabetes treatment satisfaction (DTSQ), and system usability (SUS) - before and after 3 months of AID use. Associations among participant characteristics, psychosocial measures and glycemic outcomes were evaluated using linear regression analyses.

Results: Adults using the tubeless AID system demonstrated improvements in diabetes-specific psychosocial measures, including diabetes distress, hypoglycemic confidence, insulin delivery satisfaction, diabetes treatment satisfaction, and system usability after 3 months (all P < 0.001). No changes in general well-being or sleep quality were observed. The psychosocial outcomes assessed were not consistently associated with baseline participant characteristics (i.e., age, sex, diabetes duration, glycemic outcomes including percent time in range 70-180 mg/dL, percent time below range < 70 mg/dL, hemoglobin A1c, or insulin regimen).

Conclusions: Use of the Omnipod 5 AID system was associated with significant improvements in diabetes-related psychosocial outcomes for adults with T1D.

Clinical trials registration number: NCT04196140.

Keywords: Automated insulin delivery; Closed-loop system; Psychosocial outcomes; Type 1 diabetes.

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Conflict of interest statement

Declaration of Competing Interest

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: WHP reports consulting fees from Dexcom, Abbott, and Insulet as well as grants from Dexcom and Abbott.

KKH reports consulting fees from Cecelia Health, Havas, and Cercacor.

CJL reports research support from Insulet for the conduct of this study as well as from Dexcom, Tandem Diabetes Care, and Abbott Diabetes which have been paid to her institution and has received an honoraria for serving on an advisory board for Dexcom.

SAM reports personal fees from Insulet, during the conduct of the study.

IBH reports research support from Medtronic Diabetes, Insulet, and Beta Bionics; and personal fees from Abbott Diabetes Care, Roche, GWave, and Bigfoot.

SAB reports research support from Insulet during the conduct of the study; research support from Dexcom, Tandem Diabetes Care, Roche Diagnostics, and Tolerion, outside the submitted work.

BWB reports research support from Insulet, during the conduct of the study, as well as research support from Abbott, Advance, Diasome, Dexcom, Janssen, Lilly, Medtronic, Novo Nordisk, Provention Bio, Sanofi, Sanvita, Senseonics, REMD Biotherapeutics, Xeris, vTv Therapeutics. BWB reports consultant and speaking fees from Boehringer Ingelheim, Insulet, Lilly, Mannkind, Medtronic, Novo Nordisk, Sanofi, Senseonics, Xeris and Zealand.

ALC reports grants from Insulet, during the conduct of the study; grants from Dexcom, grants and other from Medtronic, grants from Abbott Diabetes, grants and other from Sanofi, grants and other from Eli Lilly, other from UnitedHealth, grants from Novo Nordisk, outside the submitted work.

VNS reports grants from Dexcom, Insulet, Eli Lilly, NovoNordisk, Mylan GmBH, vTv Therapeutics, and Abbott, grants and other from Sanofi, other from Medscape LLC, outside the submitted work.

RSW reports grants from Insulet, during the conduct of the study; grants from Eli Lilly and Co, grants from Medtronic, grants from Tolerion Inc., grants from Diasome Pharmaceuticals, grants from Boehringer Ingelheim, grants from Kowa, and grant from NovoNordisk, outside the submitted work.

AB reports grant support to his employer Iowa Diabetes Research, as well as research grants from the following: Abbott Diabetes Care, AbbVie Inc., Boehringer Ingelheim Pharmaceuticals, Boston Therapeutics Inc., Covance Inc., Dexcom, Eli Lilly, Gan & Lee Pharmaceuticals, Insulet Corporation, Janssen Research & Development, LLC, Kowa Pharmaceuticals America Inc., Lexicom, Madrigal Pharmaceuticals Inc., Medtronic, Merck & Co. Inc., Mylan N.V., Novo Nordisk, Poxel, Quintiles, Rhythm Pharmaceuticals, Sanofi, Senseonics, Teijin America Inc., Tolerion Inc., Viking Therapeutics, and vTv Therapeutics LLC.

TCJ reports grant support from Insulet to his employer, East Coast Institute, for research pertaining to and outside of the submitted work.

GA reports research support from Astra-Zeneca, Dexcom, Eli Lilly, Insulet, Novo Nordisk; has served as a consultant for Dexcom and Insulet Corporation.

SNM reports grants from Insulet Corporation, outside the submitted work.

LML reports grants from Insulet, during the conduct of the study; personal fees from Eli Lilly, personal fees from Roche, personal fees from Insulet, personal fees from Dexcom, personal fees from Boehringer Ingelheim, personal fees from Janssen, personal fees from Medtronic, personal fees from Provention, personal fees from Dompe, outside the submitted work.

GPF reports grants and personal fees from Insulet, during the conduct of the study; grants and personal fees from Medtronic, grants and personal fees from Dexcom, grants from Abbott, grants and personal fees from Tandem, grants and personal fees from Lilly, grants and personal fees from Beta Bionics, outside the submitted work.

JLS reports research support from Insulet, during the conduct of the study, as well as research support from Medtronic and NIDDK. She has served on advisory boards for Bigfoot Biomedical, Cecelia Health, Insulet, Medtronic Diabetes, and Vertex. Consulting work has been done for Cecelia Health, Eli Lilly, Lexicon, Insulet, Medtronic, and Sanofi.

LMH is a full-time employee of and owns stock in Insulet Corporation.

TEV is a full-time employee of and owns stock in Insulet Corporation.

TTL is a full-time employee of and owns stock in Insulet Corporation.

References

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