Digital Therapy for Individualized Intervention and Management of Gestational Diabetes Mellitus

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Not yet enrolling

Conditions: Gestational Diabetes Mellitus (GDM)

Treatments: Device: GDM digital Therapy mini-program; Device: Pregnancy record and education mini-program

Study type: Interventional

Funder types: Other

Identifiers

NCT07173959

K8156

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups, including a placebo group

intervention group

Experimental group

Description:

This group of pregnant women received nutritional intervention and feedback provided by a digital therapy product (mini-program) relying on an AI system on the basis of routine obstetric care

Treatment:

Device: GDM digital Therapy mini-program

control group

Placebo Comparator group

Description:

Pregnant women randomly assigned to the control group used a mini-program that looked the same as digital therapy products but only had educational and recording functions on the basis of routine obstetric care

Treatment:

Device: Pregnancy record and education mini-program