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
ARTICLE HIGHLIGHTS
Research background

Technology has been playing an increasing role in the management of diabetes. The introduction of hybrid closed-loop (HCL) systems and continuous glucose monitors (CGM) was a revolutionary step toward better glycemic control. However, there is limited data on the impact of HCL on patient-reported outcomes (PROs).

Research motivation

Data on the impact of HCL systems on quality-of-life measures are limited. Knowledge and understanding of this information are of particular importance due to growing emphasis on patient-centered healthcare. This study from a specialized diabetes center may help future research to improve diabetes technology used for insulin delivery.

Research objectives

In this independent prospective observational study, we evaluated clinical and PROs among patients with T1D who used HCL system in real-world clinical practice over one year.

Research methods

Participants with T1D who were treated with HCL at Joslin Clinic from 2017 to 2019 were evaluated. We measured A1C and percent of glucose time-in-range (%TIR) at baseline and 12 months. We measured percent time in auto mode or 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.

Research results

At 12 months, A1C decreased by 0.3% ± 0.1% and %TIR increased by 8.1% ± 2.5%. The physical functioning submodule of 36Item Short-Form Health Survey increased significantly by 22.9%. Hypoglycemia fear survey/worry scale decreased significantly by 24.9%; Problem Areas In Diabetes reduced significantly by -17.2%. The emotional burden submodules of dietary diversity score reduced significantly by -44.7%.

Research conclusions

The implementation of HCL in care of T1D in real-world clinical practice for one year is associated with significant improvements in A1C, %TIR, physical functioning, hypoglycemia fear, emotional distress, and emotional burden related to diabetes management.

Research perspectives

Future research should focus on better understanding the effects of HCL system on the patients with diabetes. Larger cohorts are needed for the validation of these results and clinical care should take these outcomes into considerations when deciding on appropriate management for patients.