Improving Glycemic Control in DM2 Patients in the Ambulatory Setting

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Smart insulin pens and CGM
* Other: Point of Care Glucose Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Smart insulin pens and CGM<br>Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices | Device: Smart insulin pens and CGM<br>* Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices<br>|
| Placebo Comparator: Point of Care Glucose Group<br>Participants in this group will be monitored by point of care glucose values | Other: Point of Care Glucose Group<br>* Participants in this group will be monitored by POC glucose values.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hyperglycemia | Change in HbA1c | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hyperglycemia | Change in HbA1c | 6 months | 
| Change in hypoglycemia | Change in hypoglycemic episodes (CGM glucose <70 mg/dl for at least 15 min) | 3 months | 
| Change in hypoglycemia | Change in hypoglycemic episodes (CGM glucose <70 mg/dl for at least 15 min) | 6 months | 
| Change in clinically significant hypoglycemia | Change in clinically significant hypoglycemic episodes (CGM<54 mg/dl at least 15 min) | 3 months | 
| Change in clinically significant hypoglycemia | Change in clinically significant hypoglycemic episodes (CGM<54 mg/dl at least 15 min) | 6 months | 
| Change in Time in Range (70-180 mg/dl) | Change in CGM glucose Time in Range (70-180 mg/dl) | 3 months | 
| Change in Time in Range (70-180 mg/dl) | Change in CGM glucose Time in Range (70-180 mg/dl) | 6 months | 
| Change in Time Below Range (<70 mg/dl) | Change in CGM Time Below Range (<70 mg/dl) | 3 months | 
| Change in Time Below Range (<70 mg/dl) | Change in CGM Time Below Range (<70 mg/dl) | 6 months | 
| Change in Time Above Range (>180 mg/dl) | Change in CGM Time Above Range (>180 mg/dl) | 3 months | 
| Change in Time Above Range (>180 mg/dl) | Change in CGM Time Above Range (>180 mg/dl) | 6 months | 
| Change in Glucose Variability | Change in Coefficient of Variation (CV) | 3 months | 
| Change in Glucose Variability | Change in Coefficient of Variation (CV) | 6 months |