An interventional study of Automated Insulin Delivery (AID) and AIDANET + Fully Closed Loop (FCL) in Type 1 Diabetes (T1D), sponsored by Sue Brown. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Sue Brown · Not applicable, Interventional, and Treatment
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Sue Brown is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participant Inclusion Criteria
Participant Exclusion Criteria The participant must not have any exclusion criteria to be eligible to participate in the study.
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)
Device: Automated Insulin Delivery (AID) · Device: AIDANET + Fully Closed Loop (FCL) · Device: AIDANET + Anticipatory Closed Loop (ACL)
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).
Device: Automated Insulin Delivery (AID) · Device: AIDANET + Fully Closed Loop (FCL) · Device: AIDANET + Anticipatory Closed Loop (ACL)
Usual Care
All participants will use AIDANET in FCL mode with instructions to avoid announcing meal boluses whenever possible during the four weeks.
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.
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)
Time frame: 8 weeks
Time in range 70-140 mg/dL as computed by the study CGM
Outcome is computed if: * \>4032 values are recorded (availability condition, 2 weeks equivalent) * AND there is \>70% values between the first recorded EGV of the analysis window and the last (density condition)
Time frame: 8 weeks
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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