Continuous Glucose Monitoring, Gestational Diabetes
Conditions
Keywords
gestational diabetes, continuous glucose monitoring, glycemic Control
Brief summary
The purpose of this study is to determine if Continuous glucose monitoring improves glycemic control and pregnancy outcomes of Gestational Diabetes Mellitus
Detailed description
Gestational diabetes mellitus (GDM) is defined as any degree of glucose intolerance that is first identified during pregnancy, excluding diabetic patients diagnosed before pregnancy. The purpose of this study is to determine if Continuous glucose monitoring improves glycemic control and pregnancy outcomes of Gestational Diabetes Mellitus.
Interventions
DEVICEContinuous Glucose Monitoring System
Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) every 4 weeks since diagnosed with GDM，and the control grouponly once receive CGMS during the last month and have management adjusted based on the CGMS readings Other Name: iPro, Medtronic
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a open-label, randomized controlled trial. The investigators plan to recruit 154 women with gestational diabetes at 24-28 weeks gestation. 77 subjects (Group 1) will be selected to undergo CGM every 4 weeks and another 77 subjects will be recruited to undergo usual antenatal care ,and last month undergo CGMS (Group 2). The primary outcomes will be time in range of glycaemic control in the third trimester. The investigators also plan to assess changes to management made by the endocrinologist based on the additional information on glycemic control obtained from professional CGM use. The investigators also plan to compare hypoglycaemia and hyperglycaemia detection rates using the CGMS and fingerstick methods of glucose evaluation. Written and informed consent will be obtained in accordance with the principles of the Helsinki Declaration.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* women with gestational diabetes * 18-45 years old * 24-28 weeks gestation of pregnancy * singleton pregnancy * BMI≥18kg/m2
Exclusion criteria
* pregestational type 1 or 2 diabetes mellitus * aged \<18 or \>45 years * BMI\<18kg/m2 * multiple pregnancy * Cushing's syndrome/ using exogenous steroids * chronic infection ( HIV, Hepatitis B/C, Tuberculosis) * any active chronic systemic disease ( except essential hypertension) * Severe liver and kidney dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time in range at Week 8 after enrollment | at Week 8 after enrollment | time in range of CGMS at Week 8 after enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the level of HbA1c before delivery | 37 weeks of gestation | the level of HbA1c before delivery in two groups |
| the incidence of hypoglycemic events | 14 weeks | the incidence of hypoglycemic events (blood glucose \<3.3mmol/L, with or without hypoglycemic symptoms) during the follow-up period of patients in the two groups |
| adverse pregnancy outcomes | 3 month | adverse pregnancy outcomes (preterm, macrosomia, greater than gestational age, less than gestational age, compound end point (birth injury, neonatal hypoglycemia, hyperbilirubinemia, apgar score \< 7 within 5 minutes of birth, neonatal phototherapy, neonatal respiratory distress syndrome |
Countries
China
Contacts
Primary ContactYufan Wang, Doctor
Outcome results
None listed