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

Phase 4

• Conditions: Continuous Glucose Monitoring; Gestational Diabetes
• Interventions: Device: Continuous Glucose Monitoring System

• Registration Number: NCT03955107
• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Study Start: 2019-04-01
• Status Verified: 2019-05
• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-05-16
• Last Update Submitted: 2019-05-16
• Study First Posted: 2019-05-17
• Last Update Posted: 2019-05-20
• Primary Completion: 2020-03-01
• Study Completion: 2020-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 154

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Glucose Monitoring System	Continuous Glucose Monitoring System	-

Primary Outcome Measures

Name	Time	Method
time in range at Week 8 after enrollment	at Week 8 after enrollment	time in range of CGMS at Week 8 after enrollment

Secondary Outcome Measures

Name	Time	Method
the level of HbA1c before delivery	37 weeks of gestation	the level of HbA1c before delivery in 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
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

Trial Locations

Locations (1)

Shanghai First People's Hospital, Shanghai Jiao Tong University 100 Haining Road,Shanghai; 🇨🇳 Shanghai, Shanghai, China