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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
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This is an observational study. Forty females with type 1 diabetes (age 18-40) using a continuous glucose monitor and an insulin pump will be enrolled for a 3-month data collection. Study participants will include free-cycling females and females following oral contraceptive therapy. All study appointments may be completed virtually.
Females, age 18-40 y.o., diagnosed with type 1 diabetes and currently using an insulin pump, will be provided a study continuous glucose monitor (CGM) in order to collect 3 full menstrual cycle data within 180 days. Enrollment may last from 3-5 months. Study participants will include free-cycling females and females following oral contraceptive therapy. Study CGMs and activity trackers will be provided for the entire data collection period. During data collection, all participants will be asked to record meals consumed and free-cycling females will be asked to confirm ovulation by means of study-provided ovulation kits. The Clue app will be recommended to study participants to record dates of beginning of menses and ovulation (if applicable).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Free-cycling females | Continuous glucose monitor (CGM) data will be collected for three (3) full menstrual cycles. At the end of data collection, data will be analyzed to track insulin sensitivity and glycemic variability changes across the menstrual cycle. Participants will be asked to record meals consumed and free-cycling females will be asked to confirm ovulation by means of study-provided ovulation kits. Participants will be asked to record dates of beginning of menses and ovulation. Participants will also be provide an activity tracker to wear during the duration of the trial. |
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| Females taking Monophasic contraception | Continuous glucose monitor (CGM) data will be collected for three (3) full menstrual cycles. At the end of data collection, data will be analyzed to track insulin sensitivity and glycemic variability changes across the menstrual cycle. Participants will be asked to record meals consumed and free-cycling females will be asked to confirm ovulation by means of study-provided ovulation kits. Participants will be asked to record dates of beginning of menses and ovulation. Participants will also be provide an activity tracker to wear during the duration of the trial. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitor | Device | Data collection only |
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| Measure | Description | Time Frame |
|---|---|---|
| Insulin sensitivity computed using a Kalman filter-base algorithm embedding a model of glucose-insulin dynamics. | Primary Variable | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
Regularly menstruating females (at least every month with no missed cycles)
Females between the ages of 18 and 40 with no signs of menopause either free cycling or taking a monophasic contraception.
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| Name | Affiliation | Role |
|---|---|---|
| Chiara Fabris, PhD | University of Virginia Center for Diabetes Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Center for Diabetes Technology | Charlottesville | Virginia | 22903 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 28, 2021 | Mar 25, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 28, 2021 | Mar 25, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |