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To evaluate the safety and feasibility of a novel self-learning bolus calculator along with simplified meal announcement (AID+InsuLearn-SMA) in adolescents and young adults with T1D using Automated Insulin Delivery.
Following recruitment and screening, participants will be randomized to one of two sequences during the Hotel Admission: AID+InsuLearn-SMA→AID+CC or AID+CC→AID+InsuLearn-SMA. All participants will be trained on the study equipment, which includes (i) the DiAs smartphone running the Control-IQ algorithm with either the InsuLearn-SMA bolus calculator or the standard carbohydrate counting bolus calculator, and (ii) the Dexcom CGM. All participants will complete 7 days/6 nights run-in At-Home Period using the AID+CC system (Control-IQ with the standard carbohydrate counting bolus calculator). Participants will then undergo a 2-night supervised hotel admission (approximately 48 hours). During this admission, each participant will consume two standardized meals (dinner and breakfast), during which either the InsuLearn-SMA bolus calculator or the standard CC bolus calculator will be used in a randomized order. Two lunches will be offered during the Hotel Admission but not included in the analysis. Following discharge, all participants will complete 7 days/6 nights At-Home Period using the AID+InsuLearn-SMA system before returning the study equipment. The INSPIRE Questionnaire will be administered before and after the Hotel Admission. Additionally, participants will be asked to provide a 2-week CGM data download of their usual care for statistical analysis before randomization and after returning the equipment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AID + InsuLearn-SMA | Experimental | Participant will use their Automated insulin delivery (AID) system [insulin pump] along with InsuLearn simplified meal announcement bolus calculator |
|
| Carbohydrate Counting | Placebo Comparator | Participant will use their Automated insulin delivery (AID) system [insulin pump] and their usual carbohydrate counting bolus calculator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AID + InsuLearn-SMA | Device | Automated insulin delivery (AID) system with InsuLearn simplified meal announcement bolus calculator |
|
| Measure | Description | Time Frame |
|---|---|---|
| TIR (70-180 mg/dL) | The primary outcome will be the CGM-measured time in range (TIR, 70-180 mg/dL) during the hotel portion. | 18 hours |
| Measure | Description | Time Frame |
|---|---|---|
| TIR (70-180 mg/dL) | The primary outcome will be the CGM-measured time in range (TIR, 70-180 mg/dL) during the at-home period. | 1-week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Schoelwer, MD | University of Virginia School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Center for Diabetes Technology | Charlottesville | Virginia | 22903-2981 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 11, 2026 | May 2, 2026 |
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| AID + CC | Device | Automated insulin delivery (AID) system using usual carbohydrate counting bolus calculator |
|
| ICF_000.pdf |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D007316 | Insemination, Artificial, Heterologous |
| ID | Term |
|---|---|
| D007315 | Insemination, Artificial |
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D007314 | Insemination |
| D012098 | Reproduction |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
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