No carb counting needed? new insulin calculator tested in small trial
NCT ID NCT06411548
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Type 1 diabetes mellitus are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a glucose sensor and family coaching tame type 1 diabetes in toddlers?
- Can a smartphone app help heal diabetic foot wounds?
- Can a handoff plan help teens with chronic illness take charge of their care?
- Cheap blood test could flag diabetic kidney damage before it strikes
- Can a common blood pressure pill protect insulin cells in kids with type 1 diabetes?
- Can a 15-Day wearable sensor keep blood sugar on target?