Digital Therapy for Individualized Intervention and Management of Gestational Diabetes Mellitus

Not Applicable

Not yet recruiting

• Conditions: Gestational Diabetes Mellitus (GDM)

• Registration Number: NCT07173959
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-08
• Study First Submitted QC: 2025-09-08
• Last Update Submitted: 2025-09-08
• Study First Posted: 2025-09-15
• Last Update Posted: 2025-09-15
• Study Start: 2025-10-08
• Primary Completion: 2026-05-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

• 24 to 28 weeks of pregnancy GDM was diagnosed by OGTT test single pregnancy Be able to use smart phone APP to conduct intervention management based on digital therapy software program

Exclusion Criteria

• Suffering from type 1 or type 2 diabetes Other serious organic diseases With severe mental disorders Intervention management cannot be carried out as planned using digital therapeutics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The rate of achieving blood glucose targets	From enrollment to the end of treatment at 16 weeks

Secondary Outcome Measures

Name	Time	Method
Weight gain during pregnancy	From enrollment to the end of treatment at 16 weeks
The incidence of adverse pregnancy outcomes	During childbirth