Safety and Feasibility Testing of a Smaller Network Version of AIDANET

NCT06633965 | Completed Results FDA Device

• 1 other identifier: 301828
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized 1:1 crossover trial that intends to demonstrate feasibility and safety of the Automated Insulin Delivery as Adaptive NETwork (AIDANET) system run in a new smaller network version, used in full closed loop (FCL) by adults who have been diagnosed with type 1 diabetes (T1D).

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes; Meal Boluses; Fully Closed Loop (FCL); AIDANET

Outcome Measures

Primary Outcomes (1)

• Change in the Mean Continuous Glucose Monitor (CGM) Between the Week of the Usual Care Observational Period and the Week of AIDANET At-Home.

  This study represents a small pilot study to assess the safety and efficacy of the small-version AIDANET system and is not formally powered. Nevertheless, the randomized crossover design will allow for analysis of period effects between Group A and Group B. Comparison between these groups will be made to determine if a period effect can explain part of the benefit of the FCL system during the at-home period.

  2 weeks

Secondary Outcomes (3)

• Difference in Percent Time-in-range

  2 weeks

• Difference in Percent Time-below-range

  2 weeks

• Difference in Percent Time-in-tight-range

  2 weeks

Study Arms (2)

Usual Care→AIDANET

ACTIVE COMPARATOR

Participants will complete 7 days/6 nights at home usual care period using their personal equipment. Participants will then use the AIDANET system during a 3 days/2 nights hotel admission. Participants will continue to use the AIDANET system at home for 7 days/6 nights.

Device: AIDANET

AIDANET→Usual Care

ACTIVE COMPARATOR

Participants will use AIDANET system during a 3 days/2 nights hotel admission. Participants will continue to use the AIDANET system at home for 7 days/6 nights and then will complete 7 days/6 nights at home usual care period using their personal equipment.

Device: AIDANET

Interventions

AIDANET DEVICE

AIDANET is a fully automated, utilizing a Bolus Priming System (BPS) that recognizes meal ingestion and delivers a quick priming dose of insulin prior to extreme blood sugar excursions.

Also known as: Group B

AIDANET→Usual Care

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥18.0 and ≤60 years old at time of consent
• Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
• Currently using insulin pump for at least three months; Any pump, either open loop or hybrid closed loop may be used.
• Currently using insulin for at least six months.
• Willingness to switch to use a commercially approved personal insulin (e.g., lispro or aspart, or biosimilar approved products) within the study pump as directed by the study team.
• Currently using a Dexcom G6 or G7 CGM.
• Has one or more supportive companions knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff that 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 capable of becoming pregnant, must agree to use a form of contraception to prevent pregnancy while a participant in the study (e.g. hormonal contraception, abstinence from heterosexual intercourse). A negative serum or urine pregnancy test will be required for all females 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 use the study FCL system (CGM, pump, and phone) during the relevant study period.
• Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial.
• Willingness to participate in all study procedures including the house/hotel session, exercise challenges (e.g., one hour per day during hotel), and to consume approximately 3 unannounced meals per day during the relevant portion of the supervised hotel session.
• 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 is capable of adhering to the protocol.
• Participant is proficient in reading and writing 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, sulfonylureas). Participants may be on a stable dose of such an agent for at least the past month.
• 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.
• History of chronic renal disease (Stage 4 or unstable Stage 3b per investigator judgment) or currently on peritoneal or hemodialysis.
• History of adrenal insufficiency.
• Currently being treated for a seizure disorder.
• Hypothyroidism or hyperthyroidism that is not adequately treated.
• Coronary artery disease or other heart condition that would prevent participation in moderate intensity exercise.
• Use of oral or injectable steroids at the time of enrollment or within the last 4 weeks.
• Planned surgery during the study period.
• 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

• Marc Breton: lead
• Tandem Diabetes Care, Inc.: collaborator
• DexCom, Inc.: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22904, United States

Location

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

Limitations and Caveats

This study represents a small pilot study to assess the safety and efficacy of the small-version AIDANET system and is not formally powered.

Results Point of Contact

• Title: Dr. Marc Breton
• Organization: Center for Diabetes Technology

mb6nt@virginia.edu

434-982-6484

Study Officials

• Sue Brown, MD

  University of Virginia Center for Diabetes Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Professor

Model Details: Participants will be randomized 1:1 to assess a 1-week usual care period before use of the AIDANET system (Group A) or after use of the AIDANET system (Group B).

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 9, 2024
• Study Start: November 20, 2024
• Primary Completion: December 16, 2024
• Study Completion: December 18, 2024
• Last Updated: August 14, 2025
• Results First Posted: August 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available after the publication of the manuscript.
• Access Criteria: The Data Sharing Agreements will be formulated by the study team

Locations

US (1)