A Randomized Parallel Clinical Trial of AIDANET, an Automated Insulin Delivery Algorithm, in Fully Closed-Loop Vs Hybrid Closed-Loop Mode In Adults With Type 1 Diabetes (AIDANET At Home)

NCT07039617 | Recruiting FDA Device

• 2 other identifiers: 3026565R01DK129553
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized cross-over trial assessing glycemic control on Automated insulin delivery as Adaptive Network (AIDANET) algorithm when used in three modes: AIDANET-Fully Closed Loop (FCL), AIDANET-Hybrid Closed Loop (HCL) and AIDANET allowing a mix between FCL and HCL. There will be an Automated Insulin Delivery (AID) phase with participants using their home devices and/or study continuous glucose monitor (CGM) and study-provided commercial Mobi system without AIDANET.

Conditions

Type 1 Diabetes

Keywords

Automated Insulin Delivery (AID); Fully Closed Loop (FCL); Hybrid Closed Loop (HCL); Specifically modified Mobi System; Automated Insulin Delivery as Adaptive NETwork (AIDANET)

Outcome Measures

Primary Outcomes (1)

• Time in Range (70-180 mg/dL)

  * Computed as the number of estimated glucose values ≥70mg/dL and \<180mg/dL divided by the number of valid values (defined as a number between 39 and 401) * 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)

  16 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Group A: AID first followed by AIDANET-FCL, AIDANET-HCL and then AIDANET-FCL-HCL mix

Device: AIDANET + FCL; Device: AIDANET + HCL; Device: AIDANET in FCL-HCL-mixed mode; Other: Automated Insulin Delivery (AID) (usual care)

Group B

EXPERIMENTAL

Group B: AIDANET-FCL first followed by AIDANET-HCL, AIDANET- FCL-HCL mix and AID

Device: AIDANET + FCL; Device: AIDANET + HCL; Device: AIDANET in FCL-HCL-mixed mode; Other: Automated Insulin Delivery (AID) (usual care)

Interventions

AIDANET + HCL DEVICE

All participants will use AIDANET in hybrid closed loop (HCL) mode with instructions to announce all meal boluses using carbohydrate counting or easy bolus during the four weeks. All components of AIDANET will remain active during this phase but BPS in particular is expected to be triggered less often due to meal announcements.

Group A; Group B

AIDANET in FCL-HCL-mixed mode DEVICE

All participants will use AIDANET with instructions to choose whether to use fully closed loop (FCL) or hybrid closed loop (HCL) mode with meal announcements (carb counting or easy bolus) per their discretion each day.

Group A; Group B

Automated Insulin Delivery (AID) (usual care) OTHER

Participants will manage their diabetes as they normally do at home.

Group A; Group B

AIDANET + FCL DEVICE

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

Group A; Group B

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 Type 1 Diabetes for at least one year.
• Having used an Food and Drug Administration (FDA) approved AID system within the last six months (can be intermittent use).
• Currently using insulin for at least six 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 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 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 four 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 course of 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 is capable of adhering 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. glucagon-like peptide-1 (GLP-1) receptor agonists, Symlin, (DPP-4 inhibitors, also known as dipeptidyl peptidase 4). Participants may be on a stable dose of such an agent for at least the past month.
• Current use of sulfonylurea medications.
• Current use of an Sodium-Glucose Cotransporter 2 (also known as a 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 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 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.
• Participant with a direct supervisor at work/school who is involved in the conduct of the trial.

Sponsors & Collaborators

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

Study Sites (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insemination, Artificial, Heterologous

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insemination, Artificial; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Insemination; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Sue Brown, MD

  University of Virginia Center for Diabetes Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lianna Smith

CONTACT

434-284-0893; LHS7PX@uvahealth.org

Carlene Alix

CONTACT

(434) 243-2855; uax8yx@virginia.edu

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

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 26, 2025
• Study Start: September 2, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

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)