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Gestational diabetes (GDM) is one of the most common complications of pregnancy, and up to one third of women with GDM will have abnormal blood sugars after their pregnancy. To screen for abnormal blood sugars, standard of care is a 4-12 week postpartum oral glucose tolerance test (OGTT). However only 17-60% of women actually have this test performed. This study is to assess continuous glucose monitor data from the third trimester and up to 14 days postpartum to find predictors of postpartum OGTT results.
Those with GDM in current pregnancy using a Dexcom Continuous Glucose Monitoring (CGM) are eligible for enrollment. Participants use their CGM as usual during pregnancy and wear one sensor postpartum. They have their standard of care OGTT performed at around 6 weeks. They then complete a remote questionnaire after OGTT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Gestational diabetes GDM | All participants who wear CGM and have their postpartum OGTT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| continuous glucose monitor | Device | All participants who wear CGM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of postpartum TIR <96% | Sensitivity of postpartum time in range (TIR) <96% to predict dysglycemia on OGTT. Range 70-180 mg/dL. Sensitivity determined by true positives of TIR <96% and abnormal OGTT and false negatives would be TIR <96% with normal OGTT. | up to 12 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity of postpartum TIR <96% | Specificity of postpartum TIR <96% to predict dysglycemia on OGTT Specificity calculated by true negatives are TIR not <96% and normal OGTT and false positive are TIR <96% but normal OGTT results. | up to 12 weeks postpartum |
| Experience survey questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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Diagnosis of gestational diabetes during current pregnancy, age 18 or older, and prescribed Dexcom G7
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Rancic | Contact | 212-241-5355 | sarah.rancic@mssm.edu | |
| Grenye O'Malley | Contact | 212-241-7173 | grenye.o'malley@mssm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Grenye O'Malley, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
Identifying dates
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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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6 items in non validated questionnaire to be administered remotely. first 5 questions rated on a 5 point likert scale. question 6 asks participant to choose preference between glucose sensor or oral glucose tolerance test. Each question evaluated on its own scored 1 (Strongly disagree) to 5 (Strongly Agree). The questions are not summed. |
| up to 12 weeks postpartum |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |