Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 emergency services and study staff who either lives with participant or located within approximately 30 minutes of participant and able to locate participant in the event of an emergency. 7. Participant not currently known to be pregnant or breastfeeding. 8. If participant can become pregnant, they must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all participants of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued. 9. Willingness to wear a Dexcom CGM during each of the study phases. 10. Willingness to use the study AIDANET system (CGM, pump, and phone) during the relevant study periods. 11. Willingness not to start any new non-insulin glucose-lowering agent during the trial. 12. Willingness to participate in all study procedures including in person training. 13. Access to internet at home and willingness to upload data during the study as needed. 14. Investigator has confidence that the participant can successfully operate all study devices and can adhere to the protocol. 15. Participant is proficient in reading and verbal communication in English. Participant

Exclusion Criteria

The participant must not have any exclusion criteria to be eligible to participate in the study. 1. 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. 2. Current use of sulfonylurea medications. 3. Uncontrolled microvascular complications such as active proliferative retinopathy not being treated or not responsive to current treatment. 4. Current use of an SGLT-2 or SGLT-1/2 inhibitor due to risk of euglycemic DKA. 5. Hemophilia or any other bleeding disorder. 6. History of severe hypoglycemic events with seizure or loss of consciousness in the last 12 months. 7. History of DKA event in the last 12 months. 8. Currently on peritoneal or hemodialysis. 9. Currently being treated for adrenal insufficiency. 10. Currently being treated for a seizure disorder. 11. Hypothyroidism or hyperthyroidism that is not adequately treated. 12. Use of oral or injectable steroids at the time of enrollment. 13. Known ongoing adhesive intolerance that is not well managed. 14. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk. 15. Participation in another interventional trial at the time of enrollment. 16. Participant with a direct supervisor at work/school who is involved in the conduct of the trial.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Group A: AID first followed by AIDANET+ACL then AIDANET+FCL
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)
    Usual Care
  • Device: AIDANET + 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.
  • Device: AIDANET + 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.
Active Comparator
Group B: AID first followed by AIDANET+FCL then AIDANET+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)
    Usual Care
  • Device: AIDANET + 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.
  • Device: AIDANET + 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.

Recruiting Locations

University of Virginia Center for Diabetes Technology
Charlottesville, Virginia 22903
Contact:
Sue Brown, MD
4349820602
sab2f@uvahealth.org

More Details

Status
Recruiting
Sponsor
Sue Brown

Study Contact

Andrea Riana, MD
(434) 249-6251
rys6hm@uvahealth.org

Detailed 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 with Anticipation (AIDANET+ACL) vs. AIDANET in FCL without Anticipation.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.