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

Clinical Research on Mobile Medical Used for the Standardized Management of Gestational Diabetes: a Randomized Control Trail

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04424238
Enrollment
400
Registered
2020-06-09
Start date
2016-03-15
Completion date
2020-06-30
Last updated
2020-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Glucose, Compliance, Patient, Diet Habit, GDM

Keywords

GDM, CGM, m-health, diet modification, blood glucose, compliance

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.

Interventions

BEHAVIORALm-health management

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

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
glycemic qualification rateFrom enrollment to 42 days postpartumGlycemic 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

MeasureTime frameDescription
pregnancy outcomedeliverydelivery mode, premature rupture of the membranes, preterm birth, birthweight and postpartum hemorrhage

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026