AIDANET Pediatrics

NCT07020936 | Recruiting FDA Device

• 1 other identifier: 302210
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief Summary

AIDANET algorithm with smart-phone based control system (study smart phone), specifically modified Tandem insulin system (study insulin pump), and Dexcom G6 CGM (study CGM).

Conditions

Type 1 Diabetes

Keywords

Adaptive NETwork (AIDANET) system; Fully Closed Loop (FCL); Specifically modified Mobi system

Outcome Measures

Primary Outcomes (1)

• Non-inferiority of mean CGM between FCL and Usual Care

  Non-inferiority of the mean CGM between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home

  28 days

Secondary Outcomes (9)

• GMI derived from mean CGM

  28 days

• Time in range 70-180 mg/dL

  28 days

• CGM standard deviation (StDev)

  28

• CGM coefficient of variation (CV)

  28 days

• CGM %<54 mg/dL

  28 days

Study Arms (4)

Usual Care before experimental system; system with Normal Glycemia Goal

OTHER

Participants will complete two weeks Usual Care Control Period before the use of the AIDANET system, with system employing Normal Glycemia Goal.

Device: Normal Glycemia Goal

Usual Care before experimental system; system with Tight Glycemia Goal

OTHER

Participants will complete two weeks Usual Care Control Period before the use of the AIDANET system, with system employing Tight Glycemia Goal.

Device: Tight Glycemia Goal

Usual Care after experimental system; system with Normal Glycemia Goal

OTHER

Participants will complete two weeks Usual Care Control Period after the use of the AIDANET system, with system employing Normal Glycemia Goal.

Device: Normal Glycemia Goal

Usual Care after experimental system; system with Tight Glycemia Goal

OTHER

Participants will complete two weeks Usual Care Control Period after the use of the AIDANET system, with system employing Tight Glycemia Goal.

Device: Tight Glycemia Goal

Interventions

Normal Glycemia Goal DEVICE

Participants will use the normal AIDANET system aggressivity adjustment to achieve target glucose for both the hotel and AIDANET at home periods.

Usual Care after experimental system; system with Normal Glycemia Goal; Usual Care before experimental system; system with Normal Glycemia Goal

Tight Glycemia Goal DEVICE

Participants will have the AIDANET system controller target set to have higher aggressivity adjustment to maintain target glucose for both the hotel and AIDANET at home periods.

Usual Care after experimental system; system with Tight Glycemia Goal; Usual Care before experimental system; system with Tight Glycemia Goal

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age ≥6.0 and ≤13 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 use lispro/aspart in the insulin pump during the study.
• Currently using a Dexcom G6 or G7 CGM.
• Has one or more parent/guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff that live with participant.
• 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 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 Diabetic ketoacidosis (DKA).
• Hemophilia or any other bleeding disorder.
• History of severe hypoglycemic events with seizure or loss of consciousness in the last 6 months.
• History of diabetic ketoacidosis (DKA) event in the last 6 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

• Mark D. DeBoer, MD, MSc., MCR: lead
• Tandem Diabetes Care, Inc.: collaborator
• DexCom, Inc.: collaborator

Study Sites (3)

University of California San Francisco

San Francisco, California, 94158, United States

RECRUITING

Barbara Davis Center, University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

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

• Mark DeBoer, MD

  University of Virginia Center for Diabetes Technology

  STUDY CHAIR

Central Study Contacts

Lianna Smith

CONTACT

(434) 284-0893; lhs7px@uvahealth.org

Sara Prince, RN

CONTACT

(434) 320-5599; sp4sa@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: Principal Investigator

Model Details: This study is a randomized crossover, device safety/feasibility trial with a supervised house/hotel with transition to home use, interventional trial of AIDANET.

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 13, 2025
• Study Start: July 21, 2025
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available after publication of the primary publications of the study
• Access Criteria: The data sharing agreements will be formulated by the study team.

Locations

US (3)