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

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ClinicalTrials.gov Identifier: NCT03955107
Recruitment Status : Unknown
Verified May 2019 by Yufan Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : May 17, 2019
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Yufan Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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

Condition or disease Intervention/treatment Phase
Gestational Diabetes Continuous Glucose Monitoring Device: Continuous Glucose Monitoring System Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Continuous Glucose Monitoring on Glycemic Control and Pregnancy Outcomes in Gestational Diabetes Mellitus：A Randomized Controlled Trial.
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy
Drug Information available for: Dextrose

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. the level of HbA1c before delivery [ Time Frame: 37 weeks of gestation ]
    the level of HbA1c before delivery in two groups

  2. the incidence of hypoglycemic events [ Time Frame: 14 weeks ]
    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

  3. adverse pregnancy outcomes [ Time Frame: 3 month ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955107


Contacts
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Contact: Yufan Wang, Doctor 13761675784 yyffwangdr@yahoo.com

Locations
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China, Shanghai
Shanghai First People's Hospital, Shanghai Jiao Tong University 100 Haining Road,Shanghai Recruiting
Shanghai, Shanghai, China, 200080
Contact: Fan Yu Wuang, Doctor    18918236256    yyffwangdr@yahoo.com   
Contact: Ying Huang, Doctor    17321027916    hy952@163.com   
Sponsors and Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
More Information
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Responsible Party: Yufan Wang, Director of endocrinology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03955107    
Other Study ID Numbers: CTCCR-2018BP02
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Yufan Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine:
gestational diabetes
continuous glucose monitoring
glycemic Control
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications