Clinical trial NCT04424238: the Effect of Mobile Medical Used for the Standardized Management of Gestational Diabetes
Official title: Clinical Research on Mobile Medical Used for the Standardized Management of Gestational Diabetes: a Randomized Control Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: GDM
Blood Glucose
Compliance, Patient
Diet Habit
Keywords: GDM
CGM
m-health
diet modification
blood glucose
compliance
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A multicenter, randomized controlled trial was conducted to investigate whether health education and life style management through WeChat group chat was more effective in controlling blood glucose (BG) than standard clinic prenatal care in women with GDM.

Detailed description: Most gestational diabetes mellitus (GDM) can be well controlled by health education and life style management, expecting a better pregnancy outcome. But standard clinic prenatal care which consist of clinic visit every two weeks may not give full play to the effects of GDM management. Telemedicine shows its potential to fill this gap. A multicenter, randomized controlled trial was designed to investigate whether health education and life style management through WeChat group chat was more effective in controlling blood glucose (BG) than standard clinic prenatal care in women with GDM. Women with GDM diagnosed by oral glucose tolerance test between 23-30+6 gestational weeks were randomized to a WeChat group chat-based blood glucose management group or routine clinic prenatal care. In PUMCH, investigators also equip CGM for m-health group allowing a more detailed BG information. The primary outcome was change of glycemic qualification rate during follow up period in both groups. The second outcome was pregnancy outcomes. Also, a case-control study is designed to compare the glucose control status between rice-richen meal and wheaten-richen meal, and all other macronutrients and micronutrients are all calculated and same between two groups, which may provide more clues for type of carbohydrate recommendation for Chinese women with GDM.

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 45 years.
* With singleton pregnancy
* Diagnosed as GDM by 75g oral glucose tolerance test (OGTT) and insulin treatment is not required assessed by multi-disciplinary consultation.
* Be able to use smart phone for chatting, read and write basic Chinese.
* Volunteer for research.

Exclusion Criteria:

* Pregnancies with diagnosed chronic disease
* Pregnancies with other pregnancy complications except GDM
* Pregnancies had recent trauma and treatment of glucocorticoids

Primary outcomes:
measure: glycemic qualification rate
timeFrame: From enrollment to 42 days postpartum
Secondary outcomes:
measure: pregnancy outcome
timeFrame: delivery
Other outcomes:
Locations:
Study officials:
affiliation: Chinese Academy of Medical Science & Peking Union Medical College Hospital
name: Liangkun Ma
role: STUDY_CHAIR
References: