Improving Glycemic Control With Telemedicine and Smart Insulin Pens

NCT ID: NCT06918977

Last Updated: 2026-02-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-30
• Study Completion Date: 2028-05-30

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.

Detailed Description

Diabetes is affecting millions of Americans. High glucose levels lead to complications such as heart attacks, stroke or blindness. Reducing high glucose levels may unfortunately lead to very low glucose values-hypoglycemia, a condition that can lead to loss of consciousness or even death. Both of these conditions, high and low glucose levels, can therefore lead to visits to the Emergency department or hospitalizations. In fact, patients with diabetes have frequent admissions to the hospital. Additionally, many of them are admitted again, immediately or in less than 30 days after hospital discharge.

Most patients with diabetes are monitoring their glucose values with finger-stick glucose testing. Continuous Glucose Monitors (CGM)s are new devices that can monitor glucose continuously (every couple of minutes) without the need of finger-stick glucose testing. Similar to the glucometers, CGM devices can record glucose values, which can then be obtained by the clinicians, who can help them to modify DM medications.

In addition to using CGM devices for diabetes management, smart insulin pens can be used in order to help with diabetes control. These devices can store and transfer data to the medical doctors, making them aware about the patients' glucose values.

Moreover there are different health solutions available to manage patients including mobile health and telemedicine, which can help combining and transferring these data remotely. Briefly, telemedicine is a way to deliver healthcare where providers and patients communicate through alternative methods ( for example, telephone or other electronic method) instead of traditional in-person office visits. Using telemedicine to replace some routine office visits can improve access to healthcare.

Subjects will be randomly assigned in 2 groups: One group will include patients with SIPs, CGMs and telemedicine and the other group will use traditional insulin pens, CGMs and telemedicine

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention Group

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

Group Type: EXPERIMENTAL

InPen Smart insulin pen

Intervention Type: 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.

Control Group

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

Group Type: OTHER

traditional/standard insulin pen

Intervention Type: OTHER

personal prescribed insulin pen

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.

Intervention Type: DEVICE

traditional/standard insulin pen

personal prescribed insulin pen

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Baltimore VA Maryland Center

Baltimore, Maryland, United States

Site Status: RECRUITING

VAMHCS, Diabetes Outpatient Clinic

Baltimore, Maryland, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

William Scott, MS

Role: CONTACT

william.scott5@va.gov

4106057000

Facility Contacts

Ilias Spanakis

Role: primary

ispanakis@som.umaryland.edu

617-319-9731

William H Scott

Role: backup

William.Scott5@va.gov

410-300-7747

Other Identifiers

HP-00113553

Identifier Type: -

Identifier Source: org_study_id