Gestational diabetes mellitus
Conditions
Interventions
Clinical standard care group based on finger-prick testing for self-mornitoring:Patients allocated to standard care will receive a finger-stick testing toolkit certified as medical device. They will u
Experimental group based on continuous blood glucose meters for self-monitoring:In the experimental care group, the patient will be provided a CGM toolkit certified as a medical device. The patient wi
Sponsors
Department of Public Health, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Pregnant women aged 18-45 years; Normal singleton pregnant women < 35 weeks and 0 days of pregnancy; Diagnosis of GDM by 75 g oral glucose tolerance test during 24-28 weeks of gestation; Pregnant women who do not require immediate insulin therapy after the diagnosis of GDM are monitored 2 hours after a meal and one week after confirmation.
Exclusion criteria
Exclusion criteria: Pregnant women with a history of diabetes mellitus; Pregnant women with cardiopulmonary disease or exercise restriction contraindicated by exercise intervention, gastrointestinal disease contraindicated by nutritional intervention, psychiatric illness requiring treatment, other serious illness contraindicated by lifestyle intervention; Pregnant women who do not have compliance as assessed by the Principal Investigator or Clinical Coordinator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mbined proportion of caesarean section (C-section) deliveries, shoulder dystocia occurrences and macrosomia incidences at delivery; | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c;Change in blood glucose;Fasting blood glucose;Preprandial blood glucose;Postprandial blood glucose;Time from recruitment to initiation of treatment (in weeks);Maternal body weight;Maternal BMI;Gestational age;Incidence of gestational hypertension or preeclampsia;Neonatal body weight;Incidence of neonatal hypoglycemia;Admission to the neonatal ICU; | — |
Countries
China
Contacts
Public ContactYangYang
Department of Public Health, Shanghai Jiaotong University School of Medicine
Outcome results
None listed