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.
Clinical diagnosis, based on investigator assessment, of T1D for > 1 year.
Having used an FDA approved AID system within the last 6 months (can be intermittent use).
Currently using insulin for >6 months.
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.
Plans to start a new non-insulin glucose-lowering agent (e.g., GLP-1 receptor agonists, Symlin, DPP-4 inhibitors,). Participants may be on a stable dose of such an agent for at least the past month.
Current use of sulfonylurea medications.
Uncontrolled microvascular complications such as active proliferative retinopathy not being treated or not responsive to current treatment.
Current use of an SGLT-2 or SGLT-1/2 inhibitor due to risk of euglycemic DKA.
Crossover
Automated Insulin Delivery (AID)
DeviceUsual Care
AIDANET + Fully Closed Loop (FCL)
DeviceAll participants will use AIDANET in FCL mode with instructions to avoid announcing meal boluses whenever possible during the four weeks.
AIDANET + Anticipatory Closed Loop (ACL)
DeviceAll 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 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)
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Sue Brown
Lead sponsor
University of Virginia
Sponsor institution
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Tandem Diabetes Care, Inc.
Collaborator
DexCom, Inc.
Collaborator
