Clinical trial NCT04800471: Improving Glycemic Control in DM2 Patients in the Ambulatory Setting
Official title: Improving Glycemic Control and Clinical Outcomes in DM2 Patients in the Ambulatory Setting, a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in hyperglycemia
timeFrame: 3 months
Secondary outcomes:
measure: Change in hyperglycemia
timeFrame: 6 months
measure: Change in hypoglycemia
timeFrame: 3 months
measure: Change in hypoglycemia
timeFrame: 6 months
measure: Change in clinically significant hypoglycemia
timeFrame: 3 months
measure: Change in clinically significant hypoglycemia
timeFrame: 6 months
measure: Change in Time in Range (70-180 mg/dl)
timeFrame: 3 months
measure: Change in Time in Range (70-180 mg/dl)
timeFrame: 6 months
measure: Change in Time Below Range (<70 mg/dl)
timeFrame: 3 months
measure: Change in Time Below Range (<70 mg/dl)
timeFrame: 6 months
measure: Change in Time Above Range (>180 mg/dl)
timeFrame: 3 months
measure: Change in Time Above Range (>180 mg/dl)
timeFrame: 6 months
measure: Change in Glucose Variability
timeFrame: 3 months
measure: Change in Glucose Variability
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center
state: Maryland
Study officials:
References: