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RecruitingNCT07507708INSIGHTUpdated Jun 22, 2026

Insulin Delivery With Self-Adjusting Closed-Loop and Behavioral Glycemic Control Enhanced by Prediction

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

From the registry’s dates

  • Started May 2026; still recruiting 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 1 Diabetes (T1D)

Keywords

  • Automated insulin delivery as Adaptive Network (AIDANET)
  • Fully automated Closed Loop (FCL)
  • Hybrid Closed Loop (HCL)
  • Continuous subcutaneous insulin infusion (CSII)
  • Insulin Pump
  • Tandem Mobi system
  • Anticipatory Closed Loop (ACL)
03

In context

Diabetes Mellitus, Type 1

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • 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) · Device: AIDANET + Fully Closed Loop (FCL) · Device: AIDANET + Anticipatory Closed Loop (ACL)

  • 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) · Device: AIDANET + Fully Closed Loop (FCL) · Device: AIDANET + Anticipatory Closed Loop (ACL)

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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

07

Study locations

1 of 1 sites recruiting
  • University of Virginia Center for Diabetes Technology
    Charlottesville, Virginia 22903, United States
    • Sue Brown, MD · Contact · sab2f@uvahealth.org · 4349820602
    • Marcela Moscoso-Vasquez, PhD · Sub investigator
    • Samina Afreen, MD · Sub investigator
    • Mark DeBoer, MD · Sub investigator
    • Driscoll Kimberly, PhD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07507708
Lead sponsor
Sue Brown
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Tandem Diabetes Care, Inc., DexCom, Inc.
Responsible party
Sue Brown (Study Principal Investigator, University of Virginia) — Sponsor-investigator
First posted
Apr 2, 2026
Start date
May 14, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jun 22, 2026

Study contacts

Andrea Riana, MD
Contact
rys6hm@uvahealth.org
(434) 249-6251
Laura Kollar, RN
Contact
llk7m@uvahealth.org
(434) 982-6479
Sue A Brown, MD
principal investigator · University of Virginia Center for Diabetes Technology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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