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| Name | Class |
|---|---|
| University of Virginia | OTHER |
| University of California, San Francisco | OTHER |
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Protocol Overview/Synopsis This study will be conducted at 3 sites, with each site performing a session with up to 6 participants with a lower HbA1c (<8.0%) in one of 3 age categories (26-60, 18-25, or 14-17 years) followed by a session of up to 6 additional participants with a higher HbA1c (8.0-12.0%) with the same age categories (26-60, 18-25, or 14-17 years). The trial will aim to complete a total of 36 participants: 12 total participants within each age category and 18 participants within each HbA1c category; 12 participants at each site. The study may enroll up to 70 participants to account for dropouts across the study. The study will be performed for 5 days and 4 nights at a local hotel/rental. Following the hotel session, participants will undergo a 7 day/6-night remote monitored at-home use session. The study will also conduct a two-week control period gathering data on glycemic control and insulin administration with the participants usual care therapy. Participants will be randomized 1:1, stratified by age cohort, to either group A (control period prior to AIDANET use) or group B (control period after AIDANET use).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Two-week control period before the use of the AIDANET system. |
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| Group B | Experimental | Two-week control period after the use of the AIDANET system. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIDANET system | Device | The study will involve testing a new AID system designed to enable full closed loop control and consisting of the following elements: the diabetes assistant (DiAs) prototyping platform (MAF 2019), connected to a Tandem t:AP research insulin pump and a Dexcom G6 CGM, and implementing the University of Virginia (UVA) AIDANET algorithm. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Sensor Glucose Value | The primary metric for analysis will be change in mean sensor glucose value between the second week of the control usual-care period and the one-week remote monitored at-home FCL period. | Change between second week of the control period and the one-week at home period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory P Forlenza, MD | University of Colorado Anschutz - Barbara Davis Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94158 | United States | ||
| Barbara Davis Center |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 30, 2026 | Apr 16, 2026 | 4 |
| 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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Treatment Groups Randomized Crossover: Participants will be randomized 1:1 within each age cohort to either conduct the two-week control period before use of the AIDANET system (group A) or after use of the AIDANET system (group B).
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|
| Aurora |
| Colorado |
| 80045 |
| United States |
| University of Virginia | Charlottesville | Virginia | 22904 | United States |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |