Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in Adolescents With Type 1 Diabetes Using Automated Insulin Delivery

NCT07212179 | Recruiting FDA Device

• 1 other identifier: 302850
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and feasibility of a novel self-learning bolus calculator along with simplified meal announcement (AID+InsuLearn-SMA) in adolescents and young adults with T1D using Automated Insulin Delivery.

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes (T1D); Automated Insulin Delivery (AID); Continuous Glucose Monitor (CGM); Diabetes Assistant (DiAs); Carbohydrate Counting (CC); Simplified Meal Announcement (SMA)

Outcome Measures

Primary Outcomes (1)

• TIR (70-180 mg/dL)

  The primary outcome will be the CGM-measured time in range (TIR, 70-180 mg/dL) during the hotel portion.

  18 hours

Secondary Outcomes (1)

• TIR (70-180 mg/dL)

  1-week

Study Arms (2)

AID + InsuLearn-SMA

EXPERIMENTAL

Participant will use their Automated insulin delivery (AID) system \[insulin pump\] along with InsuLearn simplified meal announcement bolus calculator

Device: AID + InsuLearn-SMA

Carbohydrate Counting

PLACEBO COMPARATOR

Participant will use their Automated insulin delivery (AID) system \[insulin pump\] and their usual carbohydrate counting bolus calculator

Device: AID + CC

Interventions

AID + CC DEVICE

Automated insulin delivery (AID) system using usual carbohydrate counting bolus calculator

Carbohydrate Counting

AID + InsuLearn-SMA DEVICE

Automated insulin delivery (AID) system with InsuLearn simplified meal announcement bolus calculator

AID + InsuLearn-SMA

Eligibility Criteria

• Age: 14 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age ≥14.0 and ≤21 years old at time of consent
• HbA1c ≤ 10%.
• Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
• Having used an insulin pump within the last three months.
• Currently using insulin for at least six months
• Willingness to use insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections
• Willingness to switch to a commercially approved 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 caregivers or companions living with the participant who are knowledgeable about emergency procedures for treatment of severe hypoglycemia and able to contact emergency services and study staff.
• Acceptable forms of contraception for participants of child-bearing potential include hormonal treatments including IUD, abstinence from heterosexual intercourse, vasectomy in partner, barrier methods (e.g. condom or diaphragm).
• For females, not currently known to be pregnant or breastfeeding. 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 InsuLearn system (CGM, pump, and phone) during the study period.
• Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial.
• Access to internet at home and ability 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:

• History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment
• Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
• Pregnancy or intent to become pregnant during the trial
• Currently breastfeeding or planning to breastfeed
• Currently being treated for a seizure disorder
• Planned surgery during study duration
• History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted)
• Treatment with any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals)
• A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
• Participation in another interventional trial at the time of enrollment.
• Visual impairment/blindness that prevents proper interaction with study equipment
• Participant who may have a falsely eligible HbA1c due to medical conditions or blood donations.
• Participants in whom the G6 CGM may be inaccurate due to interference.

Sponsors & Collaborators

• Anas El Fathi: lead

Study Sites (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903-2981, 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

• Melissa Schoelwer, MD

  University of Virginia School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Prince, RN

CONTACT

434-320-5599; sp4sa@uvahealth.org

Andrea Riano, MD

CONTACT

434-249-6251; rys6hm@virginia.edu

Study Design

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

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 8, 2025
• Study Start: March 3, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (1)