Insulin Delivery With Self-Adjusting Closed-Loop and Behavioral Glycemic Control Enhanced by Prediction (INSIGHT)
Sue Brown
Summary
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Participant Inclusion Criteria 1. Age ≥18.0 years old at time of consent 2. Clinical diagnosis, based on investigator assessment, of T1D for \> 1 year. 3. Having used an FDA approved AID system within the last 6 months (can be intermittent use). 4. Currently using insulin for \>6 months. 5. Willingness to switch to use an FDA-approved personal insulin for the study pump (e.g., lispro or aspart, or biosimilar FDA-approved products) as directed by the study team. 6. Has one or more supportive companions knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergen…
Interventions
- DeviceAutomated Insulin Delivery (AID)
Usual Care
- DeviceAIDANET + Fully Closed Loop (FCL)
All participants will use AIDANET in FCL mode with instructions to avoid announcing meal boluses whenever possible during the four weeks.
- DeviceAIDANET + Anticipatory Closed Loop (ACL)
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.
Location
- University of Virginia Center for Diabetes TechnologyCharlottesville, Virginia