InsuLearn Feasibility With Type 1 Diabetes Patients Under MDI Therapy

Launched by UNIVERSITY OF VIRGINIA · May 7, 2024

Keywords

ClinConnect Summary

This clinical trial, called InsuLearn, is exploring a new way to help adults with Type 1 Diabetes who use multiple daily injections (MDI) of insulin. The goal is to see if a special program called InsuLearn, which helps optimize insulin doses based on personal data collected over four weeks, can improve diabetes management compared to regular care. Participants in the study will be randomly assigned to start either with the InsuLearn program or the usual care for a 24-hour period and then switch to the other option.

To be eligible for the trial, participants must be at least 18 years old, have been diagnosed with Type 1 Diabetes for at least one year, and have a specific level of blood sugar control (measured by HbA1c) between 7.0% and 10.0%. They should also have some difficulty with carbohydrate counting and be willing to wear a continuous glucose monitor during the study. It's important to note that certain health conditions or medications may exclude someone from participating. If you decide to join, you can expect to track your blood sugar levels closely and share your data online during the study.

Gender

ALL

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.