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

Study Overview

• Status: Unknown
• Conditions: Gestational Diabetes; Continuous Glucose Monitoring
• Intervention / Treatment: Device: Continuous Glucose Monitoring System

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 Type: Interventional
• Enrollment (Anticipated): 154
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200080
      • Recruiting
      • Shanghai First People's Hospital, Shanghai Jiao Tong University 100 Haining Road,Shanghai
      • Contact: Fan Yu Wuang, Doctor; Phone Number: 18918236256; Email: yyffwangdr@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Continuous Glucose Monitoring System	Device: Continuous Glucose Monitoring System; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2019
• Primary Completion (ANTICIPATED): March 1, 2020
• Study Completion (ANTICIPATED): April 1, 2020

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: May 16, 2019
• First Posted (ACTUAL): May 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 16, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: gestational diabetes; continuous glucose monitoring; glycemic Control
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: CTCCR-2018BP02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No