Clinical Research on Mobile Medical Used for the Standardized Management of Gestational Diabetes: a Randomized Control Trail
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 400
- Primary Endpoint
- glycemic qualification rate
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Standard Clinic Prenatal Care (Control Group)
pregnancy's prenatal care appointment would be changed to once every two weeks when diagnosed with GDM. Doctors generally ask GDM women record their daily diet, exercise, weight, BG and blood pressure for at least three days between two visits and give lifestyle guidance according to the records. If they fail to show diaries, doctors would ask them come back with record next week. If BG control is poor, medicine intervention would be considered.
m-health group (Intervention Group)
participants were managed continuously through WeChat group chat.
Intervention: m-health management (Behavioral)
Outcomes
Primary Outcomes
glycemic qualification rate
Time Frame: 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 Outcomes
- pregnancy outcome(delivery)