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

NCT07507708 | Recruiting DMC FDA Device

• 2 other identifiers: 3029965R01DK129553
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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)

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  8 weeks

Study Arms (2)

Group A: AID first followed by AIDANET+ACL then AIDANET+FCL

ACTIVE COMPARATOR

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)

Group B: AID first followed by AIDANET+FCL then AIDANET+ACL

ACTIVE COMPARATOR

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

Automated Insulin Delivery (AID) DEVICE

Usual Care

Group A: AID first followed by AIDANET+ACL then AIDANET+FCL; Group B: AID first followed by AIDANET+FCL then AIDANET+ACL

AIDANET + Fully Closed Loop (FCL) DEVICE

All participants will use AIDANET in FCL mode with instructions to avoid announcing meal boluses whenever possible during the four weeks.

Group A: AID first followed by AIDANET+ACL then AIDANET+FCL; Group B: AID first followed by AIDANET+FCL then AIDANET+ACL

AIDANET + Anticipatory Closed Loop (ACL) DEVICE

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.

Group A: AID first followed by AIDANET+ACL then AIDANET+FCL; Group B: AID first followed by AIDANET+FCL then AIDANET+ACL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18.0 years old at time of consent
• 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.
• 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.
• Participant not currently known to be pregnant or breastfeeding.
• 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.
• Willingness to wear a Dexcom CGM during each of the study phases.
• Willingness to use the study AIDANET system (CGM, pump, and phone) during the relevant study periods.
• Willingness not to start any new non-insulin glucose-lowering agent during the trial.
• Willingness to participate in all study procedures including in person training.
• Access to internet at home and willingness to upload data during the study as needed.
• Investigator has confidence that the participant can successfully operate all study devices and can adhere to the protocol.
• Participant is proficient in reading and verbal communication in English.

You may not qualify if:

• 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.
• Hemophilia or any other bleeding disorder.
• History of severe hypoglycemic events with seizure or loss of consciousness in the last 12 months.
• History of DKA event in the last 12 months.
• Currently on peritoneal or hemodialysis.
• Currently being treated for adrenal insufficiency.
• Currently being treated for a seizure disorder.
• Hypothyroidism or hyperthyroidism that is not adequately treated.
• Use of oral or injectable steroids at the time of enrollment.
• Known ongoing adhesive intolerance that is not well managed.
• A condition, which in the opinion of the investigator or designee, would put the participant or study at risk.
• Participation in another interventional trial at the time of enrollment.

Sponsors & Collaborators

• Sue Brown: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Tandem Diabetes Care, Inc.: collaborator
• DexCom, Inc.: collaborator

Study Sites (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Sue A Brown, MD

  University of Virginia Center for Diabetes Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Riana, MD

CONTACT

(434) 249-6251; rys6hm@uvahealth.org

Laura Kollar, RN

CONTACT

(434) 982-6479; llk7m@uvahealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: May 14, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

US (1)