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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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 groups in NCT04800471
Study groupRoleWhat they receive
Smart insulin pens and CGMActive comparatorParticipants 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 GroupPlacebo comparatorParticipants 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.

  1. 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)
  1. Change in Hyperglycemia (Percent Change in HbA1c)

    The change in Hb1Ac (baseline to 6 months) is reported in percent

    Measured: 6 months

  2. Change in Hypoglycemia

    Change in hypoglycemic episodes (CGM glucose <70 mg/dl for at least 15 min)

    Measured: 6 months

  3. Change in Hypoglycemia

    Change in hypoglycemic episodes (CGM glucose <70 mg/dl for at least 15 min)

    Measured: 3 months

  4. Change in Clinically Significant Hypoglycemia

    Change in clinically significant hypoglycemic episodes (CGM<54 mg/dl at least 15 min)

    Measured: 3 months

  5. Change in Clinically Significant Hypoglycemia

    Change in clinically significant hypoglycemic episodes (CGM<54 mg/dl at least 15 min)

    Measured: 6 months

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. Change in Glucose Variability

    Change in Coefficient of Variation (CV)

    Measured: 3 months

  13. 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.

  1. First posted16 Mar 2021
  2. Study start16 Aug 2021
  3. Primary completion9 Jul 2024
  4. Study completion9 Jul 2024

Resources

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)
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
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

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.

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