What this study is
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.
What's being tested
- InPen Smart insulin pen
Intervention · 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
Intervention · OTHER
personal prescribed insulin pen
Study details
- Official title
- Evaluation of a Novel Telemedicine Clinic for Patients With DM2 on Multiple Daily Insulin (MDI) Regimens
- Sponsor
- University of Maryland, Baltimore
- Conditions
- Diabetes Mellitus
- Enrolling
- 50 people
- Starts
- 2026-01-30
- Est. completion
- 2028-05-30
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- ≥18 years of age
- MDI insulin treated (receiving MDI for at least 3 months prior to the study)
You can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (2)
2 openBaltimore VA Maryland Center
Baltimore, Maryland, United States
RecruitingVAMHCS, Diabetes Outpatient Clinic
Baltimore, Maryland, United States
- Ilias Spanakis · Contact617-319-9731ispanakis@som.umaryland.edu
- William H Scott · Contact410-300-7747William.Scott5@va.gov
- Ilias Spanakis · Principal investigator
Not yet recruiting
Study team
Sponsor
University of Maryland, Baltimore
Study ID HP-00113553
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.