Comparison of 3 Versus 6-Month Use of CGMS in Non-Insulin Using T2DM Patients

Not Applicable

Terminated

• Conditions: Continuous Glucose Monitoring; T2DM (Type 2 Diabetes Mellitus)

• Registration Number: NCT03067480
• Lead Sponsor: East Tennessee State University

Brief Summary

To determine whether 3-month versus 6-month professional CGM utilization improves time spent in target range of 70-140mg/dl in patients with poorly controlled T2DM not treated with insulin.

Detailed Description

Patients not receiving any insulin treatment with an HbA1c ≥ 7.5% before their scheduled primary care appointment will be invited to participate in the study and wear professional CGM for at least 3 days at either 3 intervals (baseline, 3-month and 6-month) or 2 intervals (baseline and 6-month). After removal, the downloaded report will provide quantitative data to determine the percent of time spent in the target range. The 6-month data will be analyzed to determine if frequency of professional CGM wear positively affects time spent in target range.

Study Timeline

• Study First Submitted: 2017-02-24
• Study First Submitted QC: 2017-02-24
• Study First Posted: 2017-03-01
• Study Start: 2017-06-06
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. 18 years or older with a diagnosis of T2DM with a scheduled office visit with primary care provider within the next 4 weeks
2. Last 2 HbA1c values between 7.5 - 10% measured in the last 12 months
3. Treated with non-insulin therapies or therapeutic lifestyle changes
4. Never worn professional CGM or have not worn in last 12 months
5. Willing to perform requirements needed for professional CGM

Exclusion Criteria

1. Current or previous treatment with any insulin within 3 months at baseline

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time Spent in Target Range	6 Months	Time sensor glucose is between 70-140mg/dl during a 72 hour collection period

Trial Locations

Locations (1)

East Tennessee State University; 🇺🇸 Johnson City, Tennessee, United States