NCT07173959

Digital Therapy for Individualized Intervention and Management of Gestational Diabetes Mellitus

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Existing studies have shown that the management combined with digital health technology can increase the qualified rate of blood glucose in pregnant women with gestational diabetes mellitus (GDM), and the earlier the intervention, the better the effect of blood glucose control. Previously, there was a lack of relevant research on digital therapeutics for the systematic management of gestational diabetes in China. A data-driven digital therapy product for gestational diabetes (doctor's end + patient's end) was established. This product integrates functions such as information recording, risk assessment, evaluation and suggestion, prescription issuance, and knowledge popularization. It aims to provide personalized blood glucose regulation plans for pregnant women with gestational diabetes and enhance the health awareness and self-management ability of families with gestational diabetes.

Conditions

• Gestational Diabetes Mellitus (GDM)

Interventions

Type	Name	Description
DEVICE	GDM digital Therapy mini-program	The main functions of digital therapy products include personalized recipe recommendations, exercise and diet records and personalized analysis, blood sugar and weight monitoring, and the generation of weekly and monthly electronic comprehensive reports. The content of the electronic comprehensive reports includes the weight gain, blood sugar status, examination indicators, mood, and the proportion of diet and exercise of pregnant women in line with the system's recommendations during this period of time.
DEVICE	Pregnancy record and education mini-program	This mini-program looks the same as digital therapy products but only has the functions of education and record-keeping

Timeline

• Start date: 2025-10-08
• Primary completion: 2026-05-31
• Completion: 2026-12-31
• First posted: 2025-09-15
• Last updated: 2025-09-15