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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 4

Conditions: Gestational Diabetes; Continuous Glucose Monitoring

Treatments: Device: Continuous Glucose Monitoring System

Study type: Interventional

Funder types: Other

Identifiers

NCT03955107

CTCCR-2018BP02

Details and patient eligibility

About

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

Full 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.

Enrollment: 154 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 1 patient group

Continuous Glucose Monitoring System

Other group

Treatment:

Device: Continuous Glucose Monitoring System