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The purpose of this study is to determine if Continuous glucose monitoring improves glycemic control and pregnancy outcomes of Gestational Diabetes Mellitus
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Glucose Monitoring System | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yufan Wang, Doctor | Contact | 13761675784 | yyffwangdr@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai First People's Hospital, Shanghai Jiao Tong University 100 Haining Road,Shanghai | Recruiting | Shanghai | Shanghai Municipality | 200080 | China |
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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.
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|
| 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 |
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |
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