the Effect of Mobile Medical Used for the Standardized Management of Gestational Diabetes

Not Applicable

• Conditions: GDM; Blood Glucose; Diet Habit; Compliance, Patient
• Interventions: Behavioral: m-health management

• Registration Number: NCT04424238
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study Start: 2016-03-15
• Status Verified: 2020-05
• Study First Submitted: 2020-06-05
• Study First Submitted QC: 2020-06-05
• Study First Posted: 2020-06-09
• Last Update Submitted: 2020-06-13
• Primary Completion: 2020-06-15
• Last Update Posted: 2020-06-16
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
m-health group (Intervention Group)	m-health management	participants were managed continuously through WeChat group chat.

Primary Outcome Measures

Name	Time	Method
glycemic qualification rate	From enrollment to 42 days postpartum	Glycemic qualification rate was calculated by the number of BG within the control range /30\*100%. BG control range were fasting BG (fasting and before-sleep BG)\<95 mg/dL (5.3 mmol/L) and two-hour postprandial BG (post-breakfast, post-lunch, post-dinner BG)\<120 mg/dL (6.7 mmol/L)

Secondary Outcome Measures

Name	Time	Method
pregnancy outcome	delivery	delivery mode, premature rupture of the membranes, preterm birth, birthweight and postpartum hemorrhage