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Clinical Trials/NCT03955107
NCT03955107
Unknown
Phase 4

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

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine1 site in 1 country154 target enrollmentApril 1, 2019
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ConditionsGestational DiabetesContinuous Glucose Monitoring

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Gestational Diabetes
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Enrollment
154
Locations
1
Primary Endpoint
time in range at Week 8 after enrollment
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2019
End Date
April 1, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Responsible Party
Principal Investigator
Principal Investigator

Yufan Wang

Director of endocrinology

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Eligibility Criteria

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

Outcomes

Primary Outcomes

time in range at Week 8 after enrollment

Time Frame: at Week 8 after enrollment

time in range of CGMS at Week 8 after enrollment

Secondary Outcomes

  • the level of HbA1c before delivery(37 weeks of gestation)
  • adverse pregnancy outcomes(3 month)
  • the incidence of hypoglycemic events(14 weeks)

Study Sites (1)

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