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

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03955107
• Other study ID #: CTCCR-2018BP02
• Status: Recruiting
• Phase: Phase 4
• Start date: April 1, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: May 2019
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Yufan Wang, Doctor
• Phone: 13761675784
• Email: yyffwangdr[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: April 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Continuous Glucose Monitoring
• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

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

Locations

Country	Name	City	State
China	Shanghai First People's Hospital, Shanghai Jiao Tong University 100 Haining Road,Shanghai	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time in range at Week 8 after enrollment	time in range of CGMS at Week 8 after enrollment	at Week 8 after enrollment
Secondary	the level of HbA1c before delivery	the level of HbA1c before delivery in two groups	37 weeks of gestation
Secondary	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
Secondary	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