NCT06918977

Improving Glycemic Control With Telemedicine and Smart Insulin Pens

Evaluation of a Novel Telemedicine Clinic for Patients With DM2 on Multiple Daily Insulin (MDI) Regimens

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
OTHER	traditional/standard insulin pen	personal prescribed insulin pen

Timeline

• Start date: 2026-01-30
• Primary completion: 2028-05-30
• Completion: 2028-05-30
• First posted: 2025-04-09
• Last updated: 2026-02-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study