Recruiting

Smart Insulin Pens

Sponsor:

University of Maryland, Baltimore

Code:

NCT06918977

Conditions

Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

InPen Smart insulin pen

traditional/standard insulin pen

Study Details

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.

Conditions

Diabetes Mellitus

Study ID

NCT06918977

Start date

Jan 30, 2026

Status verified date

Feb, 2026

Completion date

May 30, 2028

Anticipated

Primary completion date

May 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention Group

Intervention group: will be managed with telehealth and InPen Smart insulin pens

other: Control Group

Control group: will be managed by telehealth and the traditional/standard insulin pen (widely used)

Interventions

InPen Smart insulin pen

InPen is a reusable pen injector which allows the user to dial the desired dose of insulin to be administered. The dose calculator a component of the InPen app calculates an insulin dose or carbohydrate intake based on user entered data. Prior to use, the patient -specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters are to be programmed into the software.

traditional/standard insulin pen

personal prescribed insulin pen

Primary outcome measure

  • Change in hyperglycemia [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

William Scott, MS

4106057000william.scott5@va.gov

Locations

Baltimore VA Maryland Center

Recruiting

Baltimore, Maryland, United States, 21201

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Keywords

  • Diabetes Mellitus
  • CGM device
  • Smart Insulin Pen

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-02-10.