Status:
NOT_YET_RECRUITING
Improving Glycemic Control With Telemedicine and Smart Insulin Pens
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
Medtronic
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Almost 40% of veterans have diabetes, the proposed research may improve clinical care among veterans with diabetes. In this application we are going to examine whether utilizing Smart Insulin pens (SI...
Detailed Description
Diabetes is affecting millions of Americans. High glucose levels lead to complications such as heart attacks, stroke or blindness. Reducing high glucose levels may unfortunately lead to very low gluco...
Eligibility Criteria
Inclusion
- ≥18 years of age
- MDI insulin treated (receiving MDI for at least 3 months prior to the study)
Exclusion
- DM patients not treated with MDI for at least 3 months (i.e diet only, any combination of non-insulin antidiabetic drugs only, basal insulin only or bolus/short acting insulin only)
- Patients with DM at the time of screening on insulin pumps
- Pregnant patients
- Patients with extensive skin disease or allergies that preclude wearing the CGM sensor
- Patients who have end-stage renal disease requiring dialysis
- Patients with significant psychiatric illness or any other condition rendering the subject incapable of understanding the objectives and potential consequences of the study
- Patients who receive hydroxyurea or who are on long (chronic) treatment with acetaminophen
- Patients who were started on non-insulin DM medications or had a dose change within 60 days or less prior to study participation
- Patient does not have or not able to gain access to a smartphone which is compatible with the necessary applications for DAT
Key Trial Info
Start Date :
November 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06918977
Start Date
November 15 2025
End Date
May 30 2028
Last Update
November 3 2025
Active Locations (1)
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1
VAMHCS, Diabetes Outpatient Clinic
Baltimore, Maryland, United States, 21201