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Completed

NCT Number: NCT04800471

Improving Glycemic Control in DM2 Patients in the Ambulatory Setting

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)

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Insulin-treated patients with DM2 (treated with basal-bolus insulin regimens (MDI), ± non-insulin medications) and Uncontrolled glycemic control

Exclusion criteria

  • 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

Treatment and study plan

Smart insulin pens and CGM

Device

Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices

Point of Care Glucose Group

Other

Participants in this group will be monitored by POC glucose values.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Hyperglycemia (Percent Change in HbA1c)

    Time frame: 6 months

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

  2. Change in Hypoglycemia

    Time frame: 6 months

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

  3. Change in Hypoglycemia

    Time frame: 3 months

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

  4. Change in Clinically Significant Hypoglycemia

    Time frame: 3 months

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

  5. Change in Clinically Significant Hypoglycemia

    Time frame: 6 months

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

  6. Change in Percentage of Glucose Values in Range (70-180 mg/dl)

    Time frame: up to 3 months

    We report the change of percentage of CGM glucose values in the range (70-180 mg/dl)

  7. Change in Percentage of Glucose Values in Range (70-180 mg/dl)

    Time frame: up to 6 months

    We report the change of percentage of CGM glucose values in the range (70-180 mg/dl)

  8. Change in Percentage of Glucose Values Below Range (<70 mg/dl)

    Time frame: 3 months

    We report the change of percentage of CGM glucose values below the range (<70 mg/dl)

  9. Change in Percentage of Glucose Values Below Range (<70 mg/dl)

    Time frame: 6 months

    We report the change of percentage of CGM glucose values below the range (<70 mg/dl)

  10. Change in Percentage of Glucose Values Above Range (>180 mg/dl)

    Time frame: 3 months

    We report the change of percentage of CGM glucose values Above Range (>180 mg/dl)

  11. Change in Percentage of Glucose Values Above Range (>180 mg/dl)

    Time frame: 6 months

    We report the change of percentage of CGM glucose values Above Range (>180 mg/dl)

  12. Change in Glucose Variability

    Time frame: 3 months

    Change in Coefficient of Variation (CV)

  13. Change in Glucose Variability

    Time frame: 6 months

    Change in Coefficient of Variation (CV)

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

Improving Glycemic Control and Clinical Outcomes in DM2 Patients in the Ambulatory Setting, a Pilot Study

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 16, 2021
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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