The Effect of Continuous Glucose Monitoring on Glycemic Control and Pregnancy Outcomes in Gestational Diabetes Mellitus

The Effect of Continuous Glucose Monitoring on Glycemic Control and Pregnancy Outcomes in Gestational Diabetes Mellitus

The Effect of Continuous Glucose Monitoring on Glycemic Control and Pregnancy Outcomes in Gestational Diabetes Mellitus：A Randomized Controlled Trial.

The purpose of this study is to determine if Continuous glucose monitoring improves glycemic control and pregnancy outcomes of Gestational Diabetes Mellitus

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.

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.

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

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 (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

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