Improving Glycemic Control With Telemedicine and Smart Insulin Pens

NCT06918977 | Recruiting FDA Device

• 1 other identifier: HP-00113553
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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

Keywords

Diabetes Mellitus; CGM device; Smart Insulin Pen

Outcome Measures

Primary Outcomes (1)

• Change in hyperglycemia

  This will be evaluated by decrease HbA1c

  3 months

Secondary Outcomes (1)

• Change in hyperglycemia

  6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Device: InPen Smart insulin pen

Control Group

OTHER

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

Other: traditional/standard insulin pen

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.

Intervention Group

traditional/standard insulin pen OTHER

personal prescribed insulin pen

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• MDI insulin treated (receiving MDI for at least 3 months prior to the study)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Medtronic: collaborator

Study Sites (2)

Baltimore VA Maryland Center

Baltimore, Maryland, 21201, United States

RECRUITING

VAMHCS, Diabetes Outpatient Clinic

Baltimore, Maryland, 21201, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

William Scott, MS

CONTACT

4106057000; william.scott5@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: January 30, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): May 30, 2028
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (2)