Smart insulin pens with CGM and telemedicine to improve blood sugar control in veterans with diabetes
Official title: Evaluation of a Novel Telemedicine Clinic for Patients With DM2 on Multiple Daily Insulin (MDI) Regimens
Run by University of Maryland, Baltimore · NCT06918977 · Data updated 2026-11-12
This trial will see if using smart insulin pens together with continuous glucose monitors (CGMs) and telemedicine helps veterans on multiple daily insulin injections control their blood sugar better than standard insulin pens with CGMs and telemedicine.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Status | Recruiting |
| Started | January 30, 2026 |
| Main results expected | May 30, 2028 |
| Study ends | May 30, 2028 |
| Registry record updated | February 10, 2026 |
| Trial ID | NCT06918977 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) who are using multiple daily insulin injections for at least three months, can wear a CGM, and receive care at the Baltimore VA diabetes clinic are the intended participants.
✕Probably not a fit
People not on MDI (including pump users), pregnant patients, those on dialysis, those who cannot wear a CGM, or those with recent non-insulin medication changes are unlikely to benefit from or qualify for this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Veterans with diabetes who have been on multiple daily injections (MDI) for at least three months will be enrolled and cared for at the Baltimore VA diabetes clinic. Participants will use CGMs and receive telemedicine follow-up, and will be assigned to either an InPen smart insulin pen or a traditional insulin pen. The smart pen arm transmits dosing data to clinicians to combine with CGM data for remote medication coaching. The main goal is to compare glycemic control and related clinical outcomes between the smart-pen group and the standard-pen group over the study period.
Why it matters
Potential benefit: If successful, combining smart insulin pens with CGMs and telemedicine could improve blood sugar control and reduce dangerous high or low glucose events for participating veterans.
How similar studies have gone: Smaller studies and real-world reports have suggested smart insulin pens can improve dosing accuracy and time-in-range, but large, definitive randomized evidence is still limited.
Who can join: the full rules
Show full inclusion / exclusion 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 access to a smartphone which is compatible with the necessary applications for DAT
Where it's running
-
Baltimore VA Maryland Center
Baltimore, Maryland, United States Recruiting -
VAMHCS, Diabetes Outpatient Clinic
Baltimore, Maryland, United States Not yet recruiting
Study contacts
- Study coordinator: William Scott, MS
- Email: william.scott5@va.gov
- Phone: 4106057000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.