InsuLearn Feasibility With Type 1 Diabetes Patients Under MDI Therapy

NCT06411548 | Completed FDA Device

• 1 other identifier: 231610
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 24-hour, randomized, crossover, single-center trial where participants are randomized to either start with the InsuLearn intervention or the usual care (UC) intervention. In the InsuLearn intervention, insulin doses are optimized using data collected in a 4-weeks at home data collection period.

Conditions

Type 1 Diabetes Mellitus

Keywords

InPen; Dexcom CGM

Outcome Measures

Primary Outcomes (1)

• Low blood glucose index (LBGI)

  The primary outcome will be, per protocol (\>70% of CGM values available after a meal), analysed using repeated measures ANOVA within-group contrast: i.e., InsuLearn vs. usual care.

  Six hours after the three meals

Study Arms (2)

InsuLearn→Usual Care

ACTIVE COMPARATOR

During the first 24 hours of the hotel admission (visit 6), participants' insulin dose will be calculated by the InsuLearn, MD approved, report. The second 24 hours of the hotel admission (visit 7), participants will use their usual care method to calculate their insulin dose.

Device: InsuLearn

Usual Care→InsuLearn

ACTIVE COMPARATOR

During the first 24 hours of the hotel admission (visit 6), participants' insulin dose will be calculated by their usual care method. The second 24 hours of the hotel admission (visit 7), participants will use the InsuLearn, MD approved, report to calculate their insulin dose.

Device: InsuLearn

Interventions

InsuLearn DEVICE

InsuLearn is an artificial intelligence (AI)-algorithm that analyses collected participants data: CGM, insulin, and meal categories to learn the optimal insulin dose. InsuLearn will run offline in a study laptop to generate the optimal insulin dose for each meal category. The algorithm will generate an ambulatory glucose profile (AGP) report with new settings for the InPen™ meal estimation bolus calculator. The study physician will review the report and the algorithm recommendations. The study physician can accept or modify the algorithm recommendations as per his judgment. The new settings will be used during the intervention admission.

InsuLearn→Usual Care; Usual Care→InsuLearn

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.
• Hemoglobin A1c (HbA1c) between 6.5% - 10.0%, inclusive, within the past 60 days.
• Currently using insulin under multiple daily injections (MDI) therapy for at least six months.
• Willingness to wear the study continuous glucose monitor (CGM) during the duration of the study.
• Access to the internet and willingness to upload data during the study as needed.
• If female and sexually active, 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.
• Investigator has confidence that the subject can successfully operate all study devices and can adhere to the protocol.
• Willingness to remain on same dose of non-insulin glucose-lowering agent during the trial (including metformin/biguanides, GLP-1 receptor agonists, pramlintide, DPP-4 inhibitors, sulfonylureas and naturaceuticals).

You may not qualify if:

• NPH (neutral protamine hagedorn) insulin
• Use of any medication that at the discretion of the investigator is deemed to interfere with the trial.
• Currently being treated for a seizure disorder.
• A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol, such as but not limited to, the following examples:
• Inpatient psychiatric treatment in the past 6 months
• Presence of a known adrenal disorder
• Abnormal liver function test results (Transaminase \>3 times the upper limit of normal)
• Abnormal renal function test results (calculated GFR \<60 mL/min/1.73m2).
• Active gastroparesis requiring medical therapy.
• Uncontrolled thyroid disease (TSH undetectable or \>10 mlU/L).
• Abuse of alcohol or recreational drugs
• Infectious process not anticipated to be resolved prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis, deep tissue infection).
• Uncontrolled arterial hypertension (Resting diastolic blood pressure \>100 mmHg and/or systolic blood pressure \>180 mmHg).
• Uncontrolled microvascular complications such as current active proliferative diabetic retinopathy defined as proliferative retinopathy requiring treatment (e.g. laser therapy or VEGF inhibitor injections) in the past 12 months.
• Currently pregnant or intent to become pregnant during the trial.

Sponsors & Collaborators

• University of Virginia: lead
• Medtronic: collaborator

Study Sites (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903-2981, 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

Study Officials

• Ralf Nass, MD

  University of Virginia Center for Diabetes Technology

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Randomized crossover: Participants will be randomized to the order that they experience the use of InsuLearn (for 24 hours each, without washout in between): InsuLearn→UC or UC→InsuLearn. UC stands for usual care.

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 13, 2024
• Study Start: March 27, 2025
• Primary Completion: October 15, 2025
• Study Completion: October 17, 2025
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

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

Locations

US (1)