Gestational Diabetes Mellitus (GDM)
Conditions
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.
Interventions
DEVICEGDM 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.
DEVICEPregnancy 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
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of achieving blood glucose targets | From enrollment to the end of treatment at 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Weight gain during pregnancy | From enrollment to the end of treatment at 16 weeks |
| The incidence of adverse pregnancy outcomes | During childbirth |
Contacts
Primary ContactLiangkun Ma
Outcome results
None listed