Improving Glycemic Control in DM2 Patients in the Ambulatory Setting

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Smart insulin pens and CGM; Other: Point of Care Glucose Group

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: William Scott; Phone Number: 4106057000; Email: william.scott5@va.gov

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Baltimore VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2021
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: HP-00095543

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes