Type 1 Diabetes MellitusInsuLearnNCT06411548
InsuLearn Feasibility With Type 1 Diabetes Patients Under MDI Therapy
A study testing InsuLearn in people with Type 1 Diabetes Mellitus, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- InsuLearn
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2025to 17 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
- Participant Exclusion Criteria
- 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.
- Currently breastfeeding.
- 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.
- Participation in another pharmaceutical or device trial at the time of enrolment or during the study.
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903-2981
About this study
Official title: Feasibility of a Bolus Calculator Without Carbohydrate Counting in Type 1 Diabetes Patients Under Multiple Daily Injections (MDI) Therapy: A Supervised Randomized Controlled Trial.
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.
Read the detailed description
Following recruitment and screening, 12 participants will be randomized to either the InsuLearn→UC or the UC→InsuLearn sequence. Participants will be trained in the use of a Continuous Glucose Monitor (CGM) (Dexcom G6 or Guardian™ 4), smart insulin pen (SIP, InPen™, Medtronic) and the InPen™ bolus calculator phone application. The InPen™ application will be set to the "meal estimation" mode where the user can select the meal category: if it is a breakfast/lunch/dinner/snack and if it has low/med/high carb amount. During the one-month data collection period, participants will be asked to use the InPen™ app to log and deliver their insulin doses. Before the hotel admission, InsuLearn will analyze the collected data to learn a new optimized insulin dose for each meal category. InsuLearn will generate a report of suggested new insulin doses that will be reviewed, approved, or changed by the study physician as needed. In the 24-h supervised interventions (hotel admission), the participant will consume three standardized meals, a med-carb lunch, a high-carb dinner, and low-carb breakfast. The insulin dose delivered in each admission will be either calculated by participants as per their UC or is as provided by the InsuLearn approved report. The two interventions are combined into a 2-day admission without a washout period.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- InsuLearn
- Keywords
- InPen, Dexcom CGM
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsuLearnDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: InsuLearn |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six hours after the three meals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start27 Mar 2025
- Primary completion15 Oct 2025
- Study completion17 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Ralf M Nass, University of Virginia
- Investigators
- Ralf Nass, MD, Principal investigator, University of Virginia Center for Diabetes Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411548
- Sponsor's protocol ID
- 231610
- Acronym
- InsuLearn
- Status last verified
- May 2026
- First submitted
- 3 May 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals in the scientific community.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Bolus Calculator Without Carbohydrate Counting in Type 1 Diabetes Patients Under Multiple Daily Injections (MDI) Therapy: A Supervised Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06411548
- Acronym / sponsor ID
- InsuLearn / 231610
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- InPen, Dexcom CGM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 17 Oct 2025 (actual)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Following recruitment and screening, 12 participants will be randomized to either the InsuLearn→UC or the UC→InsuLearn sequence. Participants will be trained in the use of a Continuous Glucose Monitor (CGM) (Dexcom G6 or Guardian™ 4), smart insulin pen (SIP, InPen™, Medtronic) and the InPen™ bolus calculator phone application. The InPen™ application will be set to the "meal estimation" mode where the user can select the meal category: if it is a breakfast/lunch/dinner/snack and if it has low/med/high carb amount. During the one-month data collection period, participants will be asked to use the InPen™ app to log and deliver their insulin doses. Before the hotel admission, InsuLearn will analyze the collected data to learn a new optimized insulin dose for each meal category. InsuLearn will generate a report of suggested new insulin doses that will be reviewed, approved, or changed by the study physician as needed. In the 24-h supervised interventions (hotel admission), the participant will consume three standardized meals, a med-carb lunch, a high-carb dinner, and low-carb breakfast. The insulin dose delivered in each admission will be either calculated by participants as per their UC or is as provided by the InsuLearn approved report. The two interventions are combined into a 2-day admission without a washout period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| InsuLearn→Usual Care | Active comparator | Device: InsuLearnDuring 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. |
| Usual Care→InsuLearn | Active comparator | Device: InsuLearnDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InsuLearnInsuLearn 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. | Device | InsuLearn→Usual Care, Usual Care→InsuLearn |
Primary outcome
Low blood glucose index (LBGI)
Time frame: Six hours after the three meals
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Yes. Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals in the scientific community.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralf Nass, MD principal investigator
University of Virginia Center for Diabetes Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InsuLearn in people with Type 1 Diabetes Mellitus, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low blood glucose index (LBGI) (time frame: Six hours after the three meals). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.