Clinical trial NCT03955107: The Effect of Continuous Glucose Monitoring on Glycemic Control and Pregnancy Outcomes in Gestational Diabetes Mellitus
Official title: The Effect of Continuous Glucose Monitoring on Glycemic Control and Pregnancy Outcomes in Gestational Diabetes Mellitus：A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gestational Diabetes
Continuous Glucose Monitoring
Keywords: gestational diabetes
continuous glucose monitoring
glycemic Control
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2019-05-17
Enrollment: 154
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: time in range at Week 8 after enrollment
timeFrame: at Week 8 after enrollment
Secondary outcomes:
measure: the level of HbA1c before delivery
timeFrame: 37 weeks of gestation
measure: the incidence of hypoglycemic events
timeFrame: 14 weeks
measure: adverse pregnancy outcomes
timeFrame: 3 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai First People's Hospital, Shanghai Jiao Tong University 100 Haining Road,Shanghai
state: Shanghai
Study officials:
References: