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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DK129553 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Tandem Diabetes Care, Inc. | INDUSTRY |
| DexCom, Inc. | INDUSTRY |
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This study is a randomized cross-over trial comparing AIDANET with Anticipation to AIDANET in FCL without Anticipation. Participants will complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then be randomized to one of two groups: Group A: AIDANET in FCL with Anticipation (AIDANET+ACL), and Group B: AIDANET in FCL without Anticipation (AIDANET+FCL). The study duration of each group is 4 weeks each. The order of these two phases will be dependent upon randomization.
The UVA AIDANET algorithm is intended for use by patients with T1D to control the subcutaneous infusion of insulin and aid in their T1D self-management. AIDANET automatically adjusts insulin delivery every 5 minutes in response to CGM values. AIDANET can be used with meal announcement (hybrid closed loop, HCL), without meal announcement (full closed loop, FCL), and with meal anticipation (anticipatory closed loop, ACL).
The purpose of this study is to demonstrate superior glycemic control when using anticipation within our latest Automated Insulin Delivery as Adaptive NETwork (AIDANET) in FCL with Anticipation (AIDANET+ACL) vs. AIDANET in FCL without Anticipation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: AID first followed by AIDANET+ACL then AIDANET+FCL | Active Comparator | Participants will first complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then complete 4 weeks of AIDANET + Anticipatory Closed Loop (ACL) and 4 weeks of AIDANET + Fully Closed-Loop (FCL) |
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| Group B: AID first followed by AIDANET+FCL then AIDANET+ACL | Active Comparator | Participants will first complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then complete 4 weeks of AIDANET + Fully Closed Loop (FCL) and 4 weeks of AIDANET+ Anticipatory Closed Loop (ACL). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated Insulin Delivery (AID) | Device | Usual Care |
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| Measure | Description | Time Frame |
|---|---|---|
| Time in range 70-140 mg/dL as computed by the study CGM | Computed as the number of estimated glucose values ≥70mg/dL and <140mg/dL divided by the number of valid values (defined as a number between 39 and 401) | 8 weeks |
| Time in range 70-140 mg/dL as computed by the study CGM | Outcome is computed if:
| 8 weeks |
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Participant Inclusion Criteria
Participant Exclusion Criteria The participant must not have any exclusion criteria to be eligible to participate in the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Riana, MD | Contact | (434) 249-6251 | rys6hm@uvahealth.org | |
| Laura Kollar, RN | Contact | (434) 982-6479 | llk7m@uvahealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Sue A Brown, MD | University of Virginia Center for Diabetes Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Center for Diabetes Technology | Recruiting | Charlottesville | Virginia | 22903 | United States |
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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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| AIDANET + Fully Closed Loop (FCL) | Device | All participants will use AIDANET in FCL mode with instructions to avoid announcing meal boluses whenever possible during the four weeks. |
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| AIDANET + Anticipatory Closed Loop (ACL) | Device | All insulin will be delivered automatically. The algorithm will review past behaviors to determine the amount of insulin that will be needed for a meal. |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |