Baltimore VA Medical Center
Baltimore, Maryland, 21201, United States
NCT Number: NCT04800471
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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Notify Me21 year and older
All sexes
Interventional
Not applicable
Baltimore, Maryland, 21201, United States
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.
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
Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices
Participants in this group will be monitored by POC glucose values.
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.
Time frame: 6 months
The change in Hb1Ac (baseline to 6 months) is reported in percent
Time frame: 6 months
Change in hypoglycemic episodes (CGM glucose <70 mg/dl for at least 15 min)
Time frame: 3 months
Change in hypoglycemic episodes (CGM glucose <70 mg/dl for at least 15 min)
Time frame: 3 months
Change in clinically significant hypoglycemic episodes (CGM<54 mg/dl at least 15 min)
Time frame: 6 months
Change in clinically significant hypoglycemic episodes (CGM<54 mg/dl at least 15 min)
Time frame: up to 3 months
We report the change of percentage of CGM glucose values in the 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)
Time frame: 3 months
We report the change of percentage of CGM glucose values below the range (<70 mg/dl)
Time frame: 6 months
We report the change of percentage of CGM glucose values below the range (<70 mg/dl)
Time frame: 3 months
We report the change of percentage of CGM 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)
Time frame: 3 months
Change in Coefficient of Variation (CV)
Time frame: 6 months
Change in Coefficient of Variation (CV)
University of Maryland, Baltimore
Other
Improving Glycemic Control and Clinical Outcomes in DM2 Patients in the Ambulatory Setting, a Pilot Study
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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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