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

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

Detailed Description
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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.

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

Conditions
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Gestational Diabetes, Continuous Glucose Monitoring

Intervention / Treatment
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* Device: Continuous Glucose Monitoring System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Continuous Glucose Monitoring System<br> | Device: Continuous Glucose Monitoring System<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time in range at Week 8 after enrollment | time in range of CGMS at Week 8 after enrollment | at Week 8 after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the level of HbA1c before delivery | the level of HbA1c before delivery in two groups | 37 weeks of gestation | 
| the incidence of hypoglycemic events | 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 | 14 weeks | 
| adverse pregnancy outcomes | 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 | 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gestational diabetes, continuous glucose monitoring, glycemic Control