Diabetes MellitusNCT06918977
Improving Glycemic Control With Telemedicine and Smart Insulin Pens
A study testing InPen Smart insulin pen and traditional/standard insulin pen in people with Diabetes Mellitus, run by University of Maryland, Baltimore at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- InPen Smart insulin pen and traditional/standard insulin pen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jan 2026to 30 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- MDI insulin treated (receiving MDI for at least 3 months prior to the study)
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Baltimore VA Maryland Center
Baltimore, Maryland, 21201
- Not yet recruiting
VAMHCS, Diabetes Outpatient Clinic
Baltimore, Maryland, 21201
Ilias Spanakis, 617-319-9731, ispanakis@som.umaryland.edu
William H Scott, 410-300-7747, William.Scott5@va.gov
About this study
Official title: Evaluation of a Novel Telemedicine Clinic for Patients With DM2 on Multiple Daily Insulin (MDI) Regimens
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.
Read the 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
- Being tested
- InPen Smart insulin pen, traditional/standard insulin pen
- Keywords
- Diabetes Mellitus, CGM device, Smart Insulin Pen
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InPen Smart insulin penDevice
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 penOther
personal prescribed insulin pen
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Intervention group: will be managed with telehealth and InPen Smart insulin pens Receives: Device: InPen Smart insulin pen |
| Control Group | Other | Control group: will be managed by telehealth and the traditional/standard insulin pen (widely used) Receives: Other: traditional/standard insulin pen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hyperglycemia
This will be evaluated by decrease HbA1c
Measured: 3 months
Secondary outcomes (1)
Change in hyperglycemia
This will be evaluated by decrease in HbA1c
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start30 Jan 2026
- Primary completion30 May 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918977
- Sponsor's protocol ID
- HP-00113553
- Status last verified
- Feb 2026
- First submitted
- 2 Apr 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Telemedicine Clinic for Patients With DM2 on Multiple Daily Insulin (MDI) Regimens
- ClinicalTrials.gov ID
- NCT06918977
- Acronym / sponsor ID
- HP-00113553
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, CGM device, Smart Insulin Pen
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: InPen Smart insulin penIntervention group: will be managed with telehealth and InPen Smart insulin pens |
| Control Group | Other | Other: traditional/standard insulin penControl group: will be managed by telehealth and the traditional/standard insulin pen (widely used) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥18 years of age
- MDI insulin treated (receiving MDI for at least 3 months prior to the study)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InPen Smart insulin penInPen 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. | Device | Intervention Group |
| traditional/standard insulin penpersonal prescribed insulin pen | Other | Control Group |
Primary outcome
Change in hyperglycemia
Time frame: 3 months
This will be evaluated by decrease HbA1c
1 secondary outcome
Change in hyperglycemia
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InPen Smart insulin pen and traditional/standard insulin pen in people with Diabetes Mellitus, run by University of Maryland, Baltimore at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William Scott, MS (4106057000, william.scott5@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hyperglycemia (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.