Diabetes MellitusNCT04800471
Improving Glycemic Control in DM2 Patients in the Ambulatory Setting
A study testing Smart insulin pens and CGM and Point of Care Glucose Group in people with Diabetes Mellitus, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
More than 10.5% of the US population has diabetes mellitus. The objective of this pilot study is to evaluate whether smart insulin pens combined with CGM devices can improve glucose control in patients with type 2 diabetes (T2D) Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Smart insulin pens and CGM and Point of Care Glucose Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2021to 9 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Insulin-treated patients with DM2 (treated with basal-bolus insulin regimens (MDI), ± non-insulin medications) and Uncontrolled glycemic control
Who cannot join
- History of type 1 DM (DM1)
- Pregnant Patients
- Extensive skin changes/disease or allergies that preclude wearing the CGM sensor
- Subjects who have end-stage renal disease requiring dialysis
- Significant psychiatric illness or any other condition rendering the subject incapable of understanding the objectives and potential consequences of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center
Baltimore, Maryland, 21201
About this study
Official title: Improving Glycemic Control and Clinical Outcomes in DM2 Patients in the Ambulatory Setting, a Pilot Study
More than 10.5% of the US population has diabetes mellitus. The objective of this pilot study is to evaluate whether smart insulin pens combined with CGM devices can improve glucose control in patients with type 2 diabetes (T2D)
Read the detailed description
Diabetes is affecting millions of Americans. High glucose levels lead to complications such as heart attacks, stroke or blindness. Patients with diabetes need to exercise at least 150 min/week, a goal however that is not usually achieved. 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 of patients with diabetes are monitoring their glucose values with finger-stick glucose testing. Continuous Glucose Monitors (CGMs) 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 (telephone or other electronic method for example) instead of only traditional in-person office visits. Using telemedicine to replace some routine office visits can improve access to healthcare. It can also improve communication between patients and providers which is often a challenge to diabetes management. You may be able to more quickly and safely change medications to help the patients' diabetes control.
In this application we are going to examine whether utilizing telemedicine is a better communication tool between patients and providers and if it will lead to improved blood sugar control and increased exercise pattern compared to traditional monitoring with glucometers and in-person office visits only. We believe that this intervention may lead to better clinical outcomes.
- Conditions
- Diabetes Mellitus
- Being tested
- Smart insulin pens and CGM, Point of Care Glucose Group
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart insulin pens and CGMDevice
Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices
Point of Care Glucose GroupOther
Participants in this group will be monitored by POC glucose values.
| Study group | Role | What they receive |
|---|---|---|
| Smart insulin pens and CGM | Active comparator | Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices Receives: Device: Smart insulin pens and CGM |
| Point of Care Glucose Group | Placebo comparator | Participants in this group will be monitored by point of care glucose values Receives: Other: Point of Care Glucose Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hyperglycemia (Percent Change in HbA1c)
HbA1C test is a blood test that shows your average level of blood glucose, also called blood sugar, over the past three months.
Measured: 3 months
Secondary outcomes (13)
Change in Hyperglycemia (Percent Change in HbA1c)
The change in Hb1Ac (baseline to 6 months) is reported in percent
Measured: 6 months
Change in Hypoglycemia
Change in hypoglycemic episodes (CGM glucose <70 mg/dl for at least 15 min)
Measured: 6 months
Change in Hypoglycemia
Change in hypoglycemic episodes (CGM glucose <70 mg/dl for at least 15 min)
Measured: 3 months
Change in Clinically Significant Hypoglycemia
Change in clinically significant hypoglycemic episodes (CGM<54 mg/dl at least 15 min)
Measured: 3 months
Change in Clinically Significant Hypoglycemia
Change in clinically significant hypoglycemic episodes (CGM<54 mg/dl at least 15 min)
Measured: 6 months
Change in Percentage of Glucose Values in Range (70-180 mg/dl)
We report the change of percentage of CGM glucose values in the range (70-180 mg/dl)
Measured: up to 3 months
Change in Percentage of Glucose Values in Range (70-180 mg/dl)
We report the change of percentage of CGM glucose values in the range (70-180 mg/dl)
Measured: up to 6 months
Change in Percentage of Glucose Values Below Range (<70 mg/dl)
We report the change of percentage of CGM glucose values below the range (<70 mg/dl)
Measured: 3 months
Change in Percentage of Glucose Values Below Range (<70 mg/dl)
We report the change of percentage of CGM glucose values below the range (<70 mg/dl)
Measured: 6 months
Change in Percentage of Glucose Values Above Range (>180 mg/dl)
We report the change of percentage of CGM glucose values Above Range (>180 mg/dl)
Measured: 3 months
Change in Percentage of Glucose Values Above Range (>180 mg/dl)
We report the change of percentage of CGM glucose values Above Range (>180 mg/dl)
Measured: 6 months
Change in Glucose Variability
Change in Coefficient of Variation (CV)
Measured: 3 months
Change in Glucose Variability
Change in Coefficient of Variation (CV)
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 posted16 Mar 2021
- Study start16 Aug 2021
- Primary completion9 Jul 2024
- Study completion9 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilias Spanakis, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800471
- Sponsor's protocol ID
- HP-00095543
- Status last verified
- Jan 2026
- First submitted
- 11 Mar 2021
- Last updated
- 10 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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
- Improving Glycemic Control and Clinical Outcomes in DM2 Patients in the Ambulatory Setting, a Pilot Study
- ClinicalTrials.gov ID
- NCT04800471
- Acronym / sponsor ID
- HP-00095543
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 16 Mar 2021 (actual)
- Results
- Posted 10 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
More than 10.5% of the US population has diabetes mellitus. The objective of this pilot study is to evaluate whether smart insulin pens combined with CGM devices can improve glucose control in patients with type 2 diabetes (T2D)
Detailed description
Diabetes is affecting millions of Americans. High glucose levels lead to complications such as heart attacks, stroke or blindness. Patients with diabetes need to exercise at least 150 min/week, a goal however that is not usually achieved. 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 of patients with diabetes are monitoring their glucose values with finger-stick glucose testing. Continuous Glucose Monitors (CGMs) 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 (telephone or other electronic method for example) instead of only traditional in-person office visits. Using telemedicine to replace some routine office visits can improve access to healthcare. It can also improve communication between patients and providers which is often a challenge to diabetes management. You may be able to more quickly and safely change medications to help the patients' diabetes control.
In this application we are going to examine whether utilizing telemedicine is a better communication tool between patients and providers and if it will lead to improved blood sugar control and increased exercise pattern compared to traditional monitoring with glucometers and in-person office visits only. We believe that this intervention may lead to better clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smart insulin pens and CGM | Active comparator | Device: Smart insulin pens and CGMParticipants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices |
| Point of Care Glucose Group | Placebo comparator | Other: Point of Care Glucose GroupParticipants in this group will be monitored by point of care glucose values |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Insulin-treated patients with DM2 (treated with basal-bolus insulin regimens (MDI), ± non-insulin medications) and Uncontrolled glycemic control
Key exclusion criteria (5 listed)
- History of type 1 DM (DM1)
- Pregnant Patients
- Extensive skin changes/disease or allergies that preclude wearing the CGM sensor
- Subjects who have end-stage renal disease requiring dialysis
- Significant psychiatric illness or any other condition rendering the subject incapable of understanding the objectives and potential consequences of the study
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 |
|---|---|---|
| Smart insulin pens and CGMParticipants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices | Device | Smart insulin pens and CGM |
| Point of Care Glucose GroupParticipants in this group will be monitored by POC glucose values. | Other | Point of Care Glucose Group |
Primary outcome
Change in Hyperglycemia (Percent Change in HbA1c)
Time frame: 3 months
HbA1C test is a blood test that shows your average level of blood glucose, also called blood sugar, over the past three months.
13 secondary outcomes
Change in Hyperglycemia (Percent Change in HbA1c)
Time frame: 6 months
Change in Hypoglycemia
Time frame: 6 months
Change in Hypoglycemia
Time frame: 3 months
Change in Clinically Significant Hypoglycemia
Time frame: 3 months
Change in Clinically Significant Hypoglycemia
Time frame: 6 months
Change in Percentage of Glucose Values in Range (70-180 mg/dl)
Time frame: up to 3 months
Change in Percentage of Glucose Values in Range (70-180 mg/dl)
Time frame: up to 6 months
Change in Percentage of Glucose Values Below Range (<70 mg/dl)
Time frame: 3 months
Change in Percentage of Glucose Values Below Range (<70 mg/dl)
Time frame: 6 months
Change in Percentage of Glucose Values Above Range (>180 mg/dl)
Time frame: 3 months
Change in Percentage of Glucose Values Above Range (>180 mg/dl)
Time frame: 6 months
Change in Glucose Variability
Time frame: 3 months
Change in Glucose Variability
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart insulin pens and CGM and Point of Care Glucose Group in people with Diabetes Mellitus, run by University of Maryland, Baltimore at 1 site 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 1 inclusion and 5 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: finished, 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 1 site 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 10 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hyperglycemia (Percent Change in HbA1c) (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.