NCT07517770

Brief Summary

Bolus Priming (BP) based on Artificial Intelligence (AI) learning of meal patterns, added to our established Automated insulin delivery as Adaptive Network (AIDANET) algorithm and running on iPhone Diabetes Assistant (iDiAs) phone wirelessly connected to Tandem Mobi insulin pump and Dexcom Continuous Glucose Monitor (CGM).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
May 2026Apr 2027

First Submitted

Initial submission to the registry

March 30, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

March 30, 2026

Last Update Submit

April 3, 2026

Conditions

Type 1 Diabetes Mellitis

Keywords

Type 1 Diabetes (T1D)Artificial-Intelligence (AI)Hybrid Closed Loop (HCL)Fully Closed Loop (FCL)Mobi insulin pumpiPhone Diabetes Assistant (iDiAs)Automated insulin delivery as Adaptive Network (AIDANET) algorithmBolus Priming System (BPS)Mobi Research App (MRA)

Outcome Measures

Primary Outcomes (1)

  • Time in Range (TIR) 70-180 mg/dL for 2-week free-living at home periods on AIDANET vs AIDANET AI.

    The last two weeks of the 4-week AIDANET AI session will be used for analysis, comparing standard Ambulatory Glucose Profile metrics across AIDANET vs AIDANET AI, with primary outcome TIR (70-180 mg/dL) during the day.

    two weeks

Study Arms (2)

GROUP A: 2 weeks HCL, 2 weeks AIDANET, and 4 weeks AIDANET AI

EXPERIMENTAL

Group A participants will continue to use their home HCL system for 2 weeks, then switch to AIDANET for two weeks, and the switch to AIDANET AI for another 4 weeks.

Device: Hybrid Closed Loop (HCL) x 2 weeksDevice: AIDANET x 2 weeksDevice: AIDANET AI x 4 weeks

GROUP B: 4 weeks AIDANET AI, 2 weeks AIDANET, and 2 weeks HCL

EXPERIMENTAL

Group B participants will begin with 4 weeks of AIDANET AI, then switch to AIDANET for 2 weeks and then revert to their home HCL systems for the last 2 weeks of the study

Device: Hybrid Closed Loop (HCL) x 2 weeksDevice: AIDANET x 2 weeksDevice: AIDANET AI x 4 weeks

Interventions

Hybrid Closed Loop (HCL) x 2 weeksDEVICE

During the HCL session, participants will be using their own HCL systems for 2-weeks.

GROUP A: 2 weeks HCL, 2 weeks AIDANET, and 4 weeks AIDANET AIGROUP B: 4 weeks AIDANET AI, 2 weeks AIDANET, and 2 weeks HCL
AIDANET x 2 weeksDEVICE

Participant will use the AIDANET algorithm on the Mobi system with the standard Bolus Priming System (BPS) automated bolus that does not require announcement of meals.

GROUP A: 2 weeks HCL, 2 weeks AIDANET, and 4 weeks AIDANET AIGROUP B: 4 weeks AIDANET AI, 2 weeks AIDANET, and 2 weeks HCL
AIDANET AI x 4 weeksDEVICE

Participant will use the AIDANET algorithm with the addition of the Bolus Priming (BP) based on AI learning of meal patterns.

GROUP A: 2 weeks HCL, 2 weeks AIDANET, and 4 weeks AIDANET AIGROUP B: 4 weeks AIDANET AI, 2 weeks AIDANET, and 2 weeks HCL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 (T1D) for at least one year.
  • Currently using an automated insulin delivery (AID) system.
  • 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.
  • Has one or more supportive companions knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff that either live 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 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 AIDANET system (CGM, insulin pump, and phone) during the 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.
  • 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., Glucagon-like peptide-1 (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 sodium-glucose transport protein 2 (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.
  • Unstable Stage 4 chronic renal disease or 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 or within the last 2 weeks.
  • Planned surgery during the study period that results in prolonged disconnection from study devices.
  • 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 involved in the conduct of the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Sue Brown, MD

    University of Virginia Center for Diabetes Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlene Alix

CONTACT

434-249-8961UAX8YX@uvahealth.org

Laura Kollar, RN

CONTACT

434-982-6479LLK7M@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 30, 2026

First Posted

April 8, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

April 8, 2026

Record last verified: 2026-04

Locations

US(1)