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Diabetes mellitus affects roughly 8% of pregnancies but is associated with significant perinatal and maternal morbidity, with 6% of pregnancies affected by gestational diabetes mellitus (GDM). Best practice guidelines recommend universal screening for gestational diabetes mellitus between 24-28 weeks of pregnancy in all women who do not have a diagnosis of pre-gestational diabetes mellitus. Among high-risk populations, performing an early diabetes screen is suggested at the initiation of prenatal care to evaluate for pre-gestational diabetes mellitus. Prior studies have demonstrated a difference in perinatal outcomes by comparing women with negative screening tests to those who fail a screen but pass a diagnostic test and those who are ultimately diagnosed with GDM. The investigators aim to use continuous glucose monitoring systems to study glycemic control in the early third trimester to further elucidate the differences between pregnant women with euglycemia, glucose intolerance, and GDM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Euglycemic | Women who pass a 50g GCT with 1-hour glucose <135 mg/dL |
| |
| Possible glucose intolerance | Women who fail a 50g GCT (1-hour glucose >135 mg/dL) and have 0/4 abnormal values on a 100g oral glucose tolerance test (OGTT) by Carpenter-Coustan values |
| |
| Confirmed glucose intolerance | Women who fail a 50g GCT (1-hour glucose >135 mg/dL) and have 1/4 abnormal values on 100g GTT test by Carpenter-Coustan values |
| |
| Gestational Diabetes Mellitus | Women who fail a 50g GCT (1-hour glucose >135 mg/dL) and have ≥2/4 abnormal values on 100g GTT test by Carpenter-Coustan values (Table 1), meeting criteria for GDM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom G6 | Device | Continuous glucose monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in glycemic control over late gestation as measured by A1c | Assessed by changes in glycemic control over late gestation as measured by HbA1c at the time of enrollment and delivery | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| The number of neonatal hypoglycemic episodes | Assessed by requirement of neonatal antidiabetic care measured in the number of hypoglycemic episode requiring IV dextrose treatment | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women
Women ages 18-45 living in central Ohio living with or without gestational diabetes mellitus
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Buschur, MD | Contact | 614-293-8045 | Elizabeth.Buschur@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Buschur, MD | tOSU Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
No IPD will be available to other researchers
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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Serum Glucose samples will be drawn
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |