Impact of Commercially-Available Hybrid Closed-Loop Systems on Sleep Outcomes in Youths and Adults With Type 1 Diabetes: A Systematic Review and Meta-Analysis

Abstract

Introduction

Closed-loop insulin delivery systems, including hybrid closed-loop (HCL) technologies, are now considered the standard of care for individuals with type 1 diabetes (T1D) and are increasingly adopted by both adults and younger populations. Beyond improving glycemic outcomes, their potential impact on patient-reported outcomes such as sleep has gained increasing attention. However, evidence regarding their effects on sleep quality and duration in individuals with T1D and their caregivers remains inconsistent.

Objectives

The objective of this study was to assess whether the use of commercially available hybrid closed-loop systems improves subjective sleep quality and objective sleep parameters in youths and adults with type 1 diabetes and in their caregivers compared with standard diabetes management.

Methods

This systematic review and meta-analysis included randomized and non-randomized studies in children, adolescents, and adults with T1D and their caregivers, evaluating commercially available hybrid closed-loop (HCL) systems. The primary outcome was the PSQI; secondary outcomes included actigraphy-derived parameters (TST, TIB, SE, SOL, NWAK, WASO). Analyses were performed separately by study design and population using a random-effects model (REML; Hartung-Knapp adjustment with IQWiG6 ad hoc correction); risk of bias was assessed with RoB 2 and ROBINS-I, and certainty of evidence with GRADE.

Results

For the PSQI, RCTs showed no statistically significant effect of HCL in subjects (6 studies, n=573; MD −0.30 [95% CI −0.92; 0.32]) or caregivers (3 studies, n=216; MD −1.39 [95% CI −3.66; 0.88]), despite a trend toward improvement in both groups. Non-randomized pre-post studies, encompassing a larger pooled sample, suggested a statistically significant improvement in sleep quality in both subjects (11 comparisons, n=672; MD −0.40 [95% CI −0.63; −0.17]) and caregivers (7 comparisons, n=372; MD −1.05 [95% CI −1.54; −0.56]).

Conclusions

Overall, the PSQI findings are directionally favorable to HCL, but the strength of inference differs by study design. The lack of a statistically significant effect in RCTs suggests that any benefit on perceived sleep quality is likely modest and still uncertain. By contrast, non-randomized pre-post studies show a clearer signal, though these results should be interpreted cautiously given their vulnerability to confounding, selection bias, and regression to the mean. The caregiver effect appears more pronounced than the subject effect, possibly reflecting a reduction in nocturnal diabetes-related burden, but this remains hypothesis-generating rather than definitive.