TY  - JOUR
AU  - Ban, Yuki
AU  - Waki, Kayo
AU  - Nakada, Ryohei
AU  - Isogawa, Akihiro
AU  - Miyoshi, Kengo
AU  - Waki, Hironori
AU  - Kato, Shunsuke
AU  - Sawaki, Hideaki
AU  - Murata, Takashi
AU  - Hirota, Yushi
AU  - Saito, Shuichiro
AU  - Nishikage, Seiji
AU  - Tone, Atsuhito
AU  - Seno, Mayumi
AU  - Toyoda, Masao
AU  - Kajino, Shinichi
AU  - Yokota, Kazuki
AU  - Tsurutani, Yuya
AU  - Yamauchi, Toshimasa
AU  - Nangaku, Masaomi
AU  - Ohe, Kazuhiko
PY  - 2025
DA  - 2025/4/14
TI  - Efficacy of a Personalized Mobile Health Intervention (BedTime) to Increase Sleep Duration Among Short-Sleeping Patients With Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial
JO  - JMIR Res Protoc
SP  - e64023
VL  - 14
KW  - digital therapeutics
KW  - behavior change
KW  - Theory of Planned Behavior
KW  - sleep duration
KW  - type 2 diabetes
KW  - randomized controlled trial
AB  - Background: A strong association exists between sleep duration and glycemic control in patients with type 2 diabetes (T2D), yet convincing evidence of a causal link remains lacking. Improving sleep is increasingly emphasized in clinical T2D treatment guidance, highlighting the need for effective, scalable sleep interventions that can affordably serve large populations through mobile health (mHealth). Objective: This study aims to pilot an intervention that extends sleep duration by modifying bedtime behavior, assessing its efficacy among short-sleeping (≤6 hours per night) patients with T2D, and establishing robust evidence that extending sleep improves glycemic control. Methods: This randomized, single-blinded, multicenter study targets 70 patients with T2D from 9 institutions in Japan over a 12-week intervention period. The sleep extension intervention, BedTime, is developed using the Theory of Planned Behavior (TPB) and focuses on TPB’s constructs of perceived and actual behavioral control (ABC). The pilot intervention combines wearable actigraphy devices with SMS text messaging managed by human operators. Both the intervention and control groups will use an actigraphy device to record bedtime, sleep duration, and step count, while time in bed (TIB) will be assessed via sleep diaries. In addition, the intervention group will receive weekly bedtime goals, daily feedback on their bedtime performance relative to those goals, identify personal barriers to an earlier bedtime, and select strategies to overcome these barriers. The 12-week intervention period will be followed by a 12-week observational period to assess the sustainability of the intervention’s effects. The primary outcome is the between-group difference in the change in hemoglobin A1c (HbA1c) at 12 weeks. Secondary outcomes include other health measures, sleep metrics (bedtime, TIB, sleep duration, total sleep time, and sleep quality), behavioral changes, and assessments of the intervention’s usability. The trial commenced on February 8, 2024, and is expected to conclude in February 2025. Results: Patient recruitment ended on August 29, 2024, with 70 participants enrolled. The intervention period concluded on December 6, 2024, and the observation period ended on February 26, 2025, with 70 participants completing the observation period. The data analysis is currently underway, and results are expected to be published in July 2025. Conclusions: This trial will provide important evidence on the causal link between increased sleep duration and improved glycemic control in short-sleeping patients with T2D. It will also evaluate the efficacy of our bedtime behavior change intervention in extending sleep duration, initially piloted with human operators, with the goal of future implementation via an mHealth smartphone app. If proven effective, this intervention could be a key step toward integrating sleep-focused mHealth into the standard treatment for patients with T2D in Japan. Trial Registration: Japan Registry of Clinical Trials jRCT1030230650; https://jrct.niph.go.jp/latest-detail/jRCT1030230650 International Registered Report Identifier (IRRID): DERR1-10.2196/64023 
SN  - 1929-0748
UR  - https://www.researchprotocols.org/2025/1/e64023
UR  - https://doi.org/10.2196/64023
DO  - 10.2196/64023
ID  - info:doi/10.2196/64023
ER  -