Optimizing insulin doses for Type 1 Diabetes patients using technology

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 study is testing a new technology to see if it can help people with Type 1 Diabetes get better insulin doses compared to their usual care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Virginia (Academic / other)
• Locations: 1 site (Charlottesville, Virginia)
• Trial ID: NCT06411548 on ClinicalTrials.gov

What this trial studies

This trial involves a 24-hour, randomized, crossover design where participants with Type 1 Diabetes will alternate between an InsuLearn intervention and usual care. Participants will use a Continuous Glucose Monitor (CGM) and a smart insulin pen to log their insulin doses over a month, allowing for personalized insulin dose optimization. During a supervised hotel stay, participants will consume standardized meals while their insulin doses are calculated based on either their usual care or the optimized recommendations from the InsuLearn system. The goal is to assess the feasibility and effectiveness of this technology in managing insulin therapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of Type 1 Diabetes for at least one year who are currently using multiple daily injections for insulin therapy.

Not a fit: Patients who are not using multiple daily injections or have an HbA1c outside the specified range may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to better insulin management and improved glycemic control for patients with Type 1 Diabetes.

How similar studies have performed: Previous studies utilizing technology for insulin management have shown promising results, indicating potential success for this novel approach.

Eligibility criteria

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.

Where this trial is running

Charlottesville, Virginia

• University of Virginia Center for Diabetes Technology — Charlottesville, Virginia, United States (Recruiting)

Study contacts

• Principal investigator: Anas Fathi, PhD — University of Virginia Center for Diabetes Technology
• Study coordinator: Viola Holmes, RD, CDCES

Conditions Type 1 Diabetes Mellitus; InPen; Dexcom CGM