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

NCT ID: NCT04424238

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-15
• Study Completion Date: 2020-06-30

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.

Conditions

GDM; Blood Glucose; Compliance, Patient; Diet Habit

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

m-health group (Intervention Group)

participants were managed continuously through WeChat group chat.

Group Type: EXPERIMENTAL

m-health management

Intervention Type: BEHAVIORAL

Patients in intervention group received additional WeChat group management when conducted standard clinic prenatal care.

Interventions

m-health management

Patients in intervention group received additional WeChat group management when conducted standard clinic prenatal care.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liangkun Ma

Role: STUDY_CHAIR

Chinese Academy of Medical Science & Peking Union Medical College Hospital

Other Identifiers

JS-1012

Identifier Type: -

Identifier Source: org_study_id