Smart insulin pens with CGM and telemedicine to improve blood sugar control in veterans with diabetes

Evaluation of a Novel Telemedicine Clinic for Patients With DM2 on Multiple Daily Insulin (MDI) Regimens

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Maryland, Baltimore (Academic / other)
• Locations: 2 sites (Baltimore, Maryland and 1 other locations)
• Trial ID: NCT06918977 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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 access to a smartphone which is compatible with the necessary applications for DAT

Where this trial is running

Baltimore, Maryland and 1 other locations

• 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

Conditions Diabetes Mellitus; CGM device; Smart Insulin Pen