Clinical trial NCT06918977: Improving Glycemic Control With Telemedicine and Smart Insulin Pens
Official title: Evaluation of a Novel Telemedicine Clinic for Patients With DM2 on Multiple Daily Insulin (MDI) Regimens
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
CGM device
Smart Insulin Pen
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2025-04-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Change in hyperglycemia
timeFrame: 3 months
Secondary outcomes:
measure: Change in hyperglycemia
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: VAMHCS, Diabetes Outpatient Clinic
state: Maryland
Study officials:
References: