Digital Therapy for Individualized Intervention and Management of Gestational Diabetes Mellitus

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.

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Key information

Conditions

Gestational Diabetes Mellitus (GDM) Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GDM digital Therapy mini-program

Device

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.

Pregnancy record and education mini-program

Device

This mini-program looks the same as digital therapy products but only has the functions of education and record-keeping

Primary outcomes

The rate of achieving blood glucose targets

Time frame: From enrollment to the end of treatment at 16 weeks

Secondary outcomes

Weight gain during pregnancy

Time frame: From enrollment to the end of treatment at 16 weeks
The incidence of adverse pregnancy outcomes

Time frame: During childbirth

Study contacts

Contact information is provided by the study sponsor or research team.

Liangkun Ma

CONTACT

[email protected]

+8613021961166

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Sep 15, 2025
Registry last updated: Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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