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

NCT03955107 | Unknown Phase 4 DMC

• 1 other identifier: CTCCR-2018BP02
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gestational Diabetes; Continuous Glucose Monitoring

Keywords

gestational diabetes; continuous glucose monitoring; glycemic Control

Outcome Measures

Primary Outcomes (1)

• time in range at Week 8 after enrollment

  time in range of CGMS at Week 8 after enrollment

  at Week 8 after enrollment

Secondary Outcomes (3)

• the level of HbA1c before delivery

  37 weeks of gestation

• the incidence of hypoglycemic events

  14 weeks

• adverse pregnancy outcomes

  3 month

Study Arms (1)

Continuous Glucose Monitoring System

OTHER

Device: Continuous Glucose Monitoring System

Interventions

Continuous Glucose Monitoring System DEVICE

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

Continuous Glucose Monitoring System

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women with gestational diabetes
• years old
• weeks gestation of pregnancy
• singleton pregnancy
• BMI≥18kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Shanghai First People's Hospital, Shanghai Jiao Tong University 100 Haining Road,Shanghai

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Central Study Contacts

Yufan Wang, Doctor

CONTACT

13761675784; yyffwangdr@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of endocrinology

Model Details: This is a open-label, randomized controlled trial. The investigators plan to recruit 154 women with gestational diabetes at 24-28 weeks gestation. 77 subjects (Group 1) will be selected to undergo CGM every 4 weeks and another 77 subjects will be recruited to undergo usual antenatal care ,and last month undergo CGMS (Group 2). The primary outcomes will be time in range of glycaemic control in the third trimester. The investigators also plan to assess changes to management made by the endocrinologist based on the additional information on glycemic control obtained from professional CGM use. The investigators also plan to compare hypoglycaemia and hyperglycaemia detection rates using the CGMS and fingerstick methods of glucose evaluation. Written and informed consent will be obtained in accordance with the principles of the Helsinki Declaration.

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 17, 2019
• Study Start: April 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: April 1, 2020
• Last Updated: May 20, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)