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No carb counting needed? new insulin calculator tested in small trial

NCT ID NCT06411548

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This small study tested a new tool called InsuLearn that helps people with type 1 diabetes calculate their insulin doses without needing to count carbohydrates. Seven adults on multiple daily injections used the tool for a day and were compared to their usual care. The goal was to see if the tool could safely manage blood sugar levels.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

7 people

The number who actually took part.

Started

Mar 2025

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥18.0 years old at time of consent. 2. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year. 3. Hemoglobin A1c (HbA1c) between 6.5% - 10.0%, inclusive, within the past 60 days. 4. Currently using insulin under multiple daily injections (MDI) therapy for at least six months. 5. Willingness to wear the study continuous glucose monitor (CGM) during the duration of the study. 6. Access to the internet and willingness to upload data during the study as needed. 7. 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. 8. Investigator has confidence that the subject can successfully operate all study devices and can adhere to the protocol. 9. 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). Participant Exclusion Criteria 1. NPH (neutral protamine hagedorn) insulin 2. Use of any medication that at the discretion of the investigator is deemed to interfere with the trial. 3. Currently being treated for a seizure disorder. 4. 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: 1. Inpatient psychiatric treatment in the past 6 months 2. Presence of a known adrenal disorder 3. Abnormal liver function test results (Transaminase \>3 times the upper limit of normal) 4. Abnormal renal function test results (calculated GFR \<60 mL/min/1.73m2). 5. Active gastroparesis requiring medical therapy. 6. Uncontrolled thyroid disease (TSH undetectable or \>10 mlU/L). 7. Abuse of alcohol or recreational drugs 8. Infectious process not anticipated to be resolved prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis, deep tissue infection). 9. Uncontrolled arterial hypertension (Resting diastolic blood pressure \>100 mmHg and/or systolic blood pressure \>180 mmHg). 10. 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. 5. Currently pregnant or intent to become pregnant during the trial. 6. Currently breastfeeding. 7. An injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication, or disease in the judgment of the investigator will affect the completion of the protocol. 8. Participation in another pharmaceutical or device trial at the time of enrolment or during the study. 9. Non-stable dose of non-insulin glucose-lowering agent during the trial (including metformin/biguanides, GLP-1 receptor agonists, pramlintide, DPP-4 inhibitors, sulfonylureas and naturaceuticals) as defined by study physician.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Virginia Center for Diabetes Technology

    Charlottesville, Virginia, 22903-2981, United States

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Other studies related to the condition(s) this trial covers.