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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Ralf Nass, MD | University of Virginia Center for Diabetes Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Center for Diabetes Technology | Charlottesville | Virginia | 22903-2981 | United States |
Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals in the scientific community.
Data will be made available after the primary manuscript is published.
The Data Sharing Agreements will be formulated by the study team
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 10, 2025 | May 5, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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.
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |