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Smart pens and telemedicine aim to tame diabetes in veterans

NCT ID NCT06918977

Disease control Sponsor: University of Maryland, Baltimore Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether using a smart insulin pen (InPen) along with a continuous glucose monitor and telemedicine can improve blood sugar control in veterans with type 2 diabetes who take multiple daily insulin injections. Fifty participants will be randomly assigned to use either the smart pen or a traditional insulin pen, both with telemedicine support. The main goal is to see if the smart pen leads to a greater drop in HbA1c, a key measure of blood sugar control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Smart insulin pen (InPen) with continuous glucose monitor and telemedicine
What this could lead to
If successful, this could show that combining smart insulin pens with telemedicine helps people with type 2 diabetes achieve better blood sugar control and fewer complications.
What could go wrong
This is a small, early-stage study with only 50 participants, so results may not apply to everyone. The smart pen relies on user input and technology, which could lead to errors or be less effective in some patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diabetes mellitus type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baltimore VA Maryland Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • VAMHCS, Diabetes Outpatient Clinic

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21201, United States

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