Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tandem Diabetes Care, Inc. | INDUSTRY |
| DexCom, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
AIDANET algorithm with smart-phone based control system (study smart phone), specifically modified Tandem insulin system (study insulin pump), and Dexcom G6 CGM (study CGM).
This study aims to demonstrate the safety and feasibility of the Automated insulin delivery as Adaptive NETwork (AIDANET) system among children age 6-13 years. This includes use of new features allowing requested correction boluses and setting a tighter glycemia goal.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care before experimental system; system with Normal Glycemia Goal | Other | Participants will complete two weeks Usual Care Control Period before the use of the AIDANET system, with system employing Normal Glycemia Goal. |
|
| Usual Care before experimental system; system with Tight Glycemia Goal | Other | Participants will complete two weeks Usual Care Control Period before the use of the AIDANET system, with system employing Tight Glycemia Goal. |
|
| Usual Care after experimental system; system with Normal Glycemia Goal | Other | Participants will complete two weeks Usual Care Control Period after the use of the AIDANET system, with system employing Normal Glycemia Goal. |
|
| Usual Care after experimental system; system with Tight Glycemia Goal | Other | Participants will complete two weeks Usual Care Control Period after the use of the AIDANET system, with system employing Tight Glycemia Goal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal Glycemia Goal | Device | Participants will use the normal AIDANET system aggressivity adjustment to achieve target glucose for both the hotel and AIDANET at home periods. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Non-inferiority of mean CGM between FCL and Usual Care | Non-inferiority of the mean CGM between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| GMI derived from mean CGM | Non-inferiority of GMI derived from the mean CGM between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home | 28 days |
| Time in range 70-180 mg/dL |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark DeBoer, MD | University of Virginia Center for Diabetes Technology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94158 | United States | ||
| Barbara Davis Center, University of Colorado |
Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals in the scientific community.
Data will be available after publication of the primary publications of the study
The data sharing agreements will be formulated by the study team.
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 30, 2025 | Apr 28, 2026 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
This study is a randomized crossover, device safety/feasibility trial with a supervised house/hotel with transition to home use, interventional trial of AIDANET.
Not provided
Not provided
Not provided
Not provided
| Tight Glycemia Goal | Device | Participants will have the AIDANET system controller target set to have higher aggressivity adjustment to maintain target glucose for both the hotel and AIDANET at home periods. |
|
Non-inferiority of time in range 70-180 mg/dL between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home
| 28 days |
| CGM standard deviation (StDev) | Non-inferiority of CGM standard deviation (StDev) between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home | 28 |
| CGM coefficient of variation (CV) | Non-inferiority of CGM coefficient of variation (CV) between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home | 28 days |
| CGM %<54 mg/dL | Non-inferiority of CGM %<54 mg/dL between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home | 28 days |
| CGM %<70 mg/dL | Non-inferiority of CGM %<70 mg/dL between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home | 28 days |
| CGM %>180 mg/dL | Non-inferiority of CGM %>180 mg/dL between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home | 28 days |
| CGM %>250 mg/dL | Non-inferiority of CGM %>250 mg/dL between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home | 28 days |
| Non-inferiority of mean CGM between Normal Glycemia Goal and Tight Glycemia Goal | Mean CGM and other outcomes listed above will be assessed between Normal Glycemia Goal and Tight Glycemia Goal groups | 17 days |
| Aurora |
| Colorado |
| 80045 |
| United States |
| University of Virginia Center for Diabetes Technology | Charlottesville | Virginia | 22903 | United States |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |