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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DK129553 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Tandem Diabetes Care, Inc. | INDUSTRY |
| DexCom, Inc. | INDUSTRY |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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A randomized cross-over trial assessing glycemic control on Automated insulin delivery as Adaptive Network (AIDANET) algorithm when used in three modes: AIDANET-Fully Closed Loop (FCL), AIDANET-Hybrid Closed Loop (HCL) and AIDANET allowing a mix between FCL and HCL. There will be an Automated Insulin Delivery (AID) phase with participants using their home devices and/or study continuous glucose monitor (CGM) and study-provided commercial Mobi system without AIDANET.
This study is a randomized cross-over trial comparing AIDANET used in three different modalities to currently available AID systems (usual care). For two 4-week phases the participants will first use the system in predetermined modality (HCL or FCL) in random order. The AIDANET system is designed to work both in full closed loop (no meal information) and in hybrid closed-loop, with carbohydrate announcement (standard bolus calculator) or easy bolus (announce timing but not carbohydrate amount), as requested by the user. During a third 4-week long phase, all participants will continue to use the system as befits their preferences (no modality will be imposed, and the user is free to go back and forth between modalities). In addition, the participant will spend 4 weeks using a usual care AID system either before the first AIDANET phase (randomization Group A) or after the last AIDANET phase (randomization Group B).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Group A: AID first followed by AIDANET-FCL, AIDANET-HCL and then AIDANET-FCL-HCL mix |
|
| Group B | Experimental | Group B: AIDANET-FCL first followed by AIDANET-HCL, AIDANET- FCL-HCL mix and AID |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIDANET + FCL | Device | All participants will use AIDANET in fully closed loop (FCL) mode with instructions to avoid announcing meal boluses whenever possible during the four weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Time in Range (70-180 mg/dL) |
| 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lianna Smith | Contact | 434-284-0893 | LHS7PX@uvahealth.org | |
| Carlene Alix | Contact | (434) 243-2855 | uax8yx@virginia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sue 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 |
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 made available after the publication of the manuscript.
The Data Sharing Agreements will be formulated by the study team
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| AIDANET + HCL | Device | All participants will use AIDANET in hybrid closed loop (HCL) mode with instructions to announce all meal boluses using carbohydrate counting or easy bolus during the four weeks. All components of AIDANET will remain active during this phase but BPS in particular is expected to be triggered less often due to meal announcements. |
|
| AIDANET in FCL-HCL-mixed mode | Device | All participants will use AIDANET with instructions to choose whether to use fully closed loop (FCL) or hybrid closed loop (HCL) mode with meal announcements (carb counting or easy bolus) per their discretion each day. |
|
| Automated Insulin Delivery (AID) (usual care) | Other | Participants will manage their diabetes as they normally do at home. |
|
| 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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