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Published Online: 26 September 2018

Psychosocial and Human Factors During a Trial of a Hybrid Closed Loop System for Type 1 Diabetes Management

Publication: Diabetes Technology & Therapeutics
Volume 20, Issue Number 10

Abstract

Background: Hybrid closed loop (HCL) systems are designed to automate insulin delivery to improve type 1 diabetes (T1D) outcomes and reduce user burden and distress. Because the systems only automate some aspects of diabetes care, psychosocial and human factors remain an important consideration in their use. Thus, we examined whether psychosocial and human factors (i.e., distress related to diabetes management, fear of hypoglycemia, and technology attitudes) would (1) change after using the system and (2) predict glycemic outcomes during the trial.
Subjects and Methods: Fourteen adults and 15 adolescents with T1D participated in a multisite clinical trial of an investigational version of the MiniMed™ 670G system (Medtronic, Northridge, CA) over 4 to 5 days in a semisupervised outpatient setting. Users completed surveys assessing psychosocial and human factors before beginning the HCL system and at the conclusion of the study. t-Tests and regression analyses were conducted to examine whether these factors changed following trial exposure to the HCL system and predicted glycemic outcomes during the trial.
Results: Diabetes management distress decreased and diabetes technology attitudes became more positive over the trial period. Fear of hypoglycemia did not change over the trial period. There was a trend toward greater pretrial management distress predicting less time in range during the trial, controlling for time in range before the trial.
Conclusions: Results suggest that this system is promising for enhancing technology attitudes and reducing management distress. Psychosocial factors, such as management distress, may negatively impact glycemic outcomes and should be a priority area for further investigation.

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Published In

cover image Diabetes Technology & Therapeutics
Diabetes Technology & Therapeutics
Volume 20Issue Number 10October 2018
Pages: 648 - 653
PubMed: 30239219

History

Published in print: October 2018
Published online: 26 September 2018
Published ahead of print: 21 September 2018

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Affiliations

Rebecca N. Adams
Department of Pediatrics, Stanford University School of Medicine, Palo Alto, California.
Molly L. Tanenbaum
Department of Pediatrics, Stanford University School of Medicine, Palo Alto, California.
Sarah J. Hanes
Department of Pediatrics, Stanford University School of Medicine, Palo Alto, California.
Jodie M. Ambrosino
Yale University School of Medicine, New Haven, Connecticut.
Trang T. Ly
Department of Pediatrics, Stanford University School of Medicine, Palo Alto, California.
School of Paediatrics and Child Health, The University of Western Australia, Crawley, Western Australia.
David M. Maahs
Department of Pediatrics, Stanford University School of Medicine, Palo Alto, California.
Diana Naranjo
Department of Pediatrics, Stanford University School of Medicine, Palo Alto, California.
Natalie Walders-Abramson
Barbara Davis Center for Childhood Diabetes, University of Colorado, Aurora, Colorado.
Stuart A. Weinzimer
Yale University School of Medicine, New Haven, Connecticut.
Bruce A. Buckingham
Department of Pediatrics, Stanford University School of Medicine, Palo Alto, California.
Korey K. Hood [email protected]
Department of Pediatrics, Stanford University School of Medicine, Palo Alto, California.

Notes

Material in this article was previously presented at the 2018 Society for Behavioral Medicine meeting in New Orleans, LA.
Protocol information is available on ClinicalTrials.gov: NCT02280863 and IDE: G140086.
Address correspondence to:Korey K. Hood, PhDDepartment of PediatricsStanford University School of Medicine780 Welch Road, MC 5776Palo Alto, CA 94304 [email protected]

Author Disclosure Statement

S.A.W. is a speaker for Medtronic and his institution has received research funding from Medtronic. He is a speaker for Tandem and Insulet and has served on advisory boards for Sanofi and Zealand Pharmaceuticals. D.M.M. is on the advisory board for Insulet and his institution has received research funding from Medtronic and DexCom. B.A.B. is on medical advisory boards for Sanofi, Novo-Nordisk, BD, UnoMedical, and Medtronic and has received research grant and/or material support from Medtronic, DexCom, LifeScan, Roche, Bayer, UnoMedical, and Tandem. T.T.L. has received honoraria from Medtronic. K.K.H. has served as a consultant to Bigfoot Biomedical and received research support from DexCom. R.N.A., M.L.T., S.J.H., J.M.A, N.W., and D.N. report no potential conflicts of interest relevant to this article.

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