Improving Glycemic Control With Telemedicine and Smart Insulin Pens

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT06918977
Status
Recruiting
Apply to this trial

Conditions

  • Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • InPen Smart insulin pen — DEVICE
    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 — OTHER
    personal prescribed insulin pen

Study Details

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.

Key Dates

Start date
Jan 30, 2026
Status verified
Feb 2026
Primary completion
May 30, 2028
Completion
May 30, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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)

Primary Outcome Measure

Change in hyperglycemia [ Time Frame: 3 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Baltimore VA Maryland CenterBaltimoreMaryland21201-
VAMHCS, Diabetes Outpatient ClinicBaltimoreMaryland21201
Ilias Spanakis
[email protected]
617-319-9731
William H Scott
[email protected]
410-300-7747
Ilias Spanakis (PRINCIPAL_INVESTIGATOR)

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By research site
Baltimore VA Maryland Center· Baltimore, MDVAMHCS, Diabetes Outpatient Clinic· Baltimore, MD

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