Observational Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Diabetes. Mar 15, 2024; 15(3): 455-462
Published online Mar 15, 2024. doi: 10.4239/wjd.v15.i3.455
Evaluation of hybrid closed-loop insulin delivery system in type 1 diabetes in real-world clinical practice: One-year observational study
Ahmed Eldib, Shilton Dhaver, Karim Kibaa, Astrid Atakov-Castillo, Tareq Salah, Marwa Al-Badri, Abdelrahman Khater, Ryan McCarragher, Omnia Elenani, Elena Toschi, Osama Hamdy
Ahmed Eldib, Shilton Dhaver, Karim Kibaa, Astrid Atakov-Castillo, Tareq Salah, Marwa Al-Badri, Abdelrahman Khater, Ryan McCarragher, Omnia Elenani, Elena Toschi, Osama Hamdy, Department of Clinical, Behavioral & Outcomes Research, Joslin Diabetes Center, Boston, MA 02215, United States
Ahmed Eldib, Karim Kibaa, Tareq Salah, Marwa Al-Badri, Abdelrahman Khater, Elena Toschi, Osama Hamdy, Department of Medicine, Harvard Medical School, Boston, MA 02115, United States
Author contributions: Eldib A, Dhaver S, Kibaa K and Hamdy O have full access to all study data and take responsibility for data integrity and accuracy of data analysis; Eldib A designed the study, collected data, conducted the statistical analysis, and prepared the manuscript; Dhaver S and Kibaa K collected data, conducted the statistical analysis, and prepared the manuscript; Atakov-Castillo A collected data and reviewed the manuscript; Al-Badri M, Salah T, Khater A, McCarragher R, Elenani O prepared, reviewed, and edited the manuscript; Toschi E and Hamdy O designed and supervised the study, reviewed, and edited the manuscript; all authors approved the final version of the manuscript.
Institutional review board statement: The study was reviewed and approved by the Committee on Human Studies at the Joslin Diabetes Center (Approval No. 2017-14).
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: Eldib A, Dhaver S, Kibaa K, Atakov-Castillo A, Salah T, Al-Badri M, Khater A, McCarragher R, Elenani O, Toschi E: Nothing to disclose. Hamdy O: Consultant to Abbott Nutrition, Sanofi Aventis; his employer Joslin Diabetes Center receives research grants from Novo-Nordisk, Eli-Lilly, Gilead Sciences, and National Dairy Council; on SAB of Twin Health; and is a shareholder of Healthimation Inc.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at tareq.salah@joslin.harvard.edu. No additional data are available.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Tareq Salah, MD, Research Fellow, Department of Clinical, Behavioral & Outcomes Research, Joslin Diabetes Center, 1 Joslin Place, Boston, MA 02215, United States. tareq.salah@joslin.harvard.edu
Received: October 26, 2023
Peer-review started: October 26, 2023
First decision: November 30, 2023
Revised: December 8, 2023
Accepted: January 15, 2024
Article in press: January 15, 2024
Published online: March 15, 2024
Processing time: 140 Days and 13.8 Hours
Abstract
BACKGROUND

In 2016, the Food and Drug Administration approved the first hybrid closed-loop (HCL) insulin delivery system for adults with type 1 diabetes (T1D). There is limited information on the impact of using HCL systems on patient-reported outcomes (PROs) in patients with T1D in real-world clinical practice. In this independent study, we evaluated glycemic parameters and PROs over one year of continuous use of Medtronic’s 670G HCL in real-world clinical practice.

AIM

To assess the effects of hybrid closed loop system on glycemic control and quality of life in adults with T1D.

METHODS

We evaluated 71 patients with T1D (mean age: 45.5 ± 12.1 years; 59% females; body weight: 83.8 ± 18.7 kg, body mass index: 28.7 ± 5.6 kg/m2, A1C: 7.6% ± 0.8%) who were treated with HCL at Joslin Clinic from 2017 to 2019. We measured A1C and percent of glucose time-in-range (%TIR) at baseline and 12 months. We measured percent time in auto mode (%TiAM) for the last two weeks preceding the final visit and assessed PROs through several validated quality-of-life surveys related to general health and diabetes management.

RESULTS

At 12 mo, A1C decreased by 0.3% ± 0.1% (P = 0.001) and %TIR increased by 8.1% ± 2.5% (P = 0.002). The average %TiAM was only 64.3% ± 32.8% and was not associated with A1C, %TIR or PROs. PROs, provided at baseline and at the end of the study, showed that the physical functioning submodule of 36Item Short-Form Health Survey increased significantly by 22.9% (P < 0.001). Hypoglycemia fear survey/worry scale decreased significantly by 24.9% (P < 0.000); Problem Areas In Diabetes reduced significantly by -17.2% (P = 0.002). The emotional burden submodules of dietary diversity score reduced significantly by -44.7% (P = 0.001). Furthermore, analysis of Clarke questionnaire showed no increase in awareness of hypoglycemic episodes. WHO-5 showed no improvements in subject’s wellbeing among participants after starting the 670G HCL system. Finally, analysis of Pittsburgh Sleep Quality Index showed no difference in sleep quality, sleep latency, or duration of sleep from baseline to 12 mo.

CONCLUSION

The use of HCL in real-world clinical practice for one year was associated with significant improvements in A1C, %TIR, physical functioning, hypoglycemia fear, emotional distress, and emotional burden related to diabetes management. However, these changes were not associated with time in auto mode.

Keywords: Artificial pancreas; Continuous blood glucose monitor; Type 1 diabetes; Hybrid closed-loop insulin delivery; Quality of life

Core Tip: There has been a growing emphasis on patient-centered healthcare and there are limited data on the impact of hybrid-closed-loop systems on quality-of-life measures. In this study, we aimed to evaluate the glycemic control and quality of life measures in patients with type 1 diabetes in a real-world clinical practice who used hybrid closed loop systems showed improvements in A1C, percent time in optimal glucose range, emotional burden and distress due to diabetes, physical functioning, and fear of hypoglycemia.