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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
| University of Pennsylvania | OTHER |
| Sansum Diabetes Research Institute | OTHER |
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The purpose of this prospective observational study is to gather exploratory and practical use data of the Dexcom Stelo Glucose Biosensing System (Stelo), an over-the-counter (OTC) real-time Continuous Glucose Monitoring (CGM) system among patients with Gestational Diabetes Mellitus (GDM) in their most recent pregnancy.
50 postpartum individuals with GDM during their most recent pregnancy will be enrolled in this prospective observational study. In a prior study looking at real-world use of Dexcom G7 CGM during pregnancy among people with GDM, feasibility was demonstrated as well as a willingness to continue CGM use during the postpartum period.
Each enrolled subject will be asked to train and wear the Dexcom Stelo glucose biosensor system continuously for the first 6 weeks after delivery and at least 1 sensor wear every 3 months (up to 15 days at 3, 6, 9, and 12 months) for the remainder of the postpartum period up to 1 year from delivery. The first insertion will be performed under trained observation and additional supplies will be provided every 3 months. Participants will be trained and instructed to enter meals, activity, lactation, and anti-diabetic medications (if applicable) in the Dexcom Stelo App as they are willing to input. Subjects will be provided education on the importance of nutrition, physical activity, and mental health in postpartum and long-term health and tips on how to use CGM data to encourage lifestyle and behavioral modifications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postpartum Stelo Users | Postpartum individuals with their most recent pregnancy complicated by Gestational Diabetes Mellitus (GDM) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom Stelo real-time Continuous Glucose Monitor | Device | The Stelo Glucose Biosensor is an over-the-counter integrated Continuous Glucose Monitor (iCGM) intended to continuously measure, record, analyze, and display glucose values in people 18 years and older not on insulin. Participants will use Stelo for the 6 weeks following delivery and for 15 days at 3 months, 6 months, 9 months, and 1 year postpartum. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Glucose | 24-hour mean glucose based on Stelo Glucose Biosensor readings | Measured from birth to 6 weeks postpartum, and for 15 days at 3, 6, 9, and 12 months postpartum. |
| Glucose Percent Time in Range | Percent time-in-range (percent of the time between 70-140 mg/dL or 70-120 mg/dL) based on Stelo Glucose Biosensor readings | Measured from birth to 6 weeks postpartum, and for 15 days at 3, 6, 9, and 12 months postpartum. |
| Glucose Percent Time Above Range | Percent time-above-range (percent of the time above 140 mg/dL or 120 mg/dL) based on Stelo Glucose Biosensor readings | Measured from birth to 6 weeks postpartum, and for 15 days at 3, 6, 9, and 12 months postpartum. |
| Postpartum Fasting Glucose | Postpartum fasting glucose as determined by a blood test | Measured at 6 and 12 months postpartum |
| Postpartum A1C | Postpartum Hemoglobin A1C as determined by a blood test | Measured at 6 and 12 months postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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Postpartum individuals with pregnancies complicated by GDM.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Huertas Pagan | Contact | 503-418-1231 | mfmresearch@ohsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amy M Valent, DO, MCR | Oregon Health and Science University | Principal Investigator |
| Celeste Durnwald, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sansum Diabetes Research Institute | Santa Barbara | California | 93105 | United States |
Data will be available upon request following publication.
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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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|
| Kristin Castorino, DO |
| Sansum Diabetes Research Institute |
| Principal Investigator |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |