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| ID | Type | Description | Link |
|---|---|---|---|
| P30DK124723 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Medstar Health Research Institute | OTHER |
| University of North Carolina, Chapel Hill | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The oral glucose tolerance test (OGTT) is the standard of care in the postpartum period to screen patients with gestational diabetes mellitus (GDM) for persistent dysglycemia. However, most patients find it burdensome and dread having to do it. Adherence rates are low (18-61%), impeding initiation of follow-up care to improve diabetes-related outcomes in subsequent pregnancies and long-term.
Continuous glucose monitoring (CGM) is an appealing alternative to the OGTT because it is a low-burden, fully remote, comprehensive assessment of glycemic status. Emerging data suggest that CGM is superior to the OGTT in identifying persistent dysglycemia at 2-5 months postpartum, and preferable to the OGTT among women willing to complete both assessments in the context of a research study. This study proposes a feasibility study of postpartum CGM among patients who do not complete the standard postpartum OGTT. The study will offer CGM in a telehealth (fully remote) context to determine if it can increase adherence to postpartum glycemic screening in real-world settings. This study will (a) evaluate uptake of CGM screening, (b) characterize patients who complete CGM, complete the OGTT, or do not complete screening, and (c) monitor initiation of follow-up care after abnormal results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postpartum CGM | Active Comparator | Postpartum continuous glucose monitoring |
|
| Postpartum OGTT | No Intervention | Postpartum oral glucose tolerance test | |
| No screening | No Intervention | No postpartum glucose screening |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous glucose monitoring for 14 days using the Freestyle LibrePro by Abbott | Other | Postpartum CGM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Continuous Glucose Monitor (CGM) uptake - Percentage of CGM-eligible patients | Percentage of CGM-eligible patients that return a used CGM sensor | 20 weeks postpartum |
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Inclusion Criteria:
Exclusion Criteria:
Postpartum
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| Name | Affiliation | Role |
|---|---|---|
| Katherine A Sauder, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
Aggregate data will be published from this pilot study; individual patient level data will be kept confidential.
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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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| 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 |
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| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |