JMIR Publications

ABSTRACT

Background:

There is a strong association between sleep duration and glycemic control in type 2 diabetes (T2D) patients, but there is a lack of convincing evidence of a causal link. Improving sleep is seeing increasing emphasis in clinical T2D treatment guidance, and there is a need for effective sleep intervention methods that can scale up to affordably serve large populations through use of mobile health (mHealth).

Objective:

In this study, we aim to pilot an intervention approach that extends sleep duration via changing bedtime behavior to investigate its efficacy among short-sleeping (6 hours or less per night) T2D patients and establish robust evidence that extending sleep causes improved glycemic control.

Methods:

This is a randomized, single-blinded, multi-center study targeting 70 T2D patients from 9 institutions in Japan with a 12-week intervention. We apply the Theory of Planned Behavior (TPB) to develop a sleep extension intervention, BedTime, targeting TPB’s constructs of perceived and actual behavioral control. The pilot intervention combines wearable actigraphy devices with text messaging controlled by human operators. The intervention and control groups will record bedtime, sleep duration, and step count using an actigraphy device, with time-in-bed (TIB) assessed via sleep diaries. The intervention group will in addition receive weekly bedtime goals, receive daily feedback on their bedtime performance relative to those goals, identify personal barriers to an earlier bedtime, and choose strategies to overcome these barriers. The 12-week intervention period will be followed by a 12-week observational period to investigate the sustainability of the intervention’s effects. The primary outcome is between-group difference in the change of HbA1c at 12 weeks. The secondary outcomes include other health measures, measurements of sleep (bedtime, TIB, sleep duration, total sleep time, sleep quality), measurements of other behavior changes, and assessments of the usability of the intervention approach. The trial began on February 8, 2024, and is intended to conclude in February 2025.

Results:

As of June 5, 2024, we have recruited 36 patients. We expect the trial to conclude by November 26, 2024, with the follow-up observation period concluding by February 18, 2025.

Conclusions:

This trial will provide important evidence on the causal link between increased sleep duration and improved glycemic control in short-sleeping T2D patients. It will also test the efficacy of our bedtime behavior change intervention in improving sleep duration by piloting using human operators, with the goal of future implementation via an mHealth smartphone application. If this study proves the intervention to be effective, it could be a key step towards the development and deployment of sleep-focused mHealth as part of the standard treatment received by T2D patients in Japan. Clinical Trial: jRCT1030230650