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Recruiting NCT06918977

Improving Glycemic Control With Telemedicine and Smart Insulin Pens

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Plain-language summary for patients

Trial Parameters

Condition Diabetes Mellitus
Sponsor University of Maryland, Baltimore
Study Type INTERVENTIONAL
Phase N/A
Enrollment 50
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2026-01-30
Completion 2028-05-30
Interventions
InPen Smart insulin pentraditional/standard insulin pen

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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 (SIPs) with CGMs and telemedicine is a better tool for managing diabetes compared to traditional insulin pens, CGMs and telemedicine, leading to improved blood sugar control and better clinical outcomes.

Eligibility Criteria

Inclusion Criteria: * ≥18 years of age * MDI insulin treated (receiving MDI for at least 3 months prior to the study) Exclusion Criteria: * 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 ac

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