NCT03067480

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

Comparison of 3 Versus 6-Month Use of Professional Continuous Glucose Monitoring in the Treatment of Poorly Controlled, Non-Insulin Using T2DM Patients in a Primary Care Setting

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: East Tennessee State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• T2DM (Type 2 Diabetes Mellitus)
• Continuous Glucose Monitoring

Interventions

Type	Name	Description
DEVICE	iPro2 Professional CGM	Professional CGM measures interstitial glucose every 5 minutes via a glucose-oxidase-impregnated membrane during a 3 day period. The patient wearing professional CGM is blinded to the repeated measurements and the data is stored for retrospective analysis.

Timeline

• Start date: 2017-06-06
• Primary completion: 2019-09-30
• Completion: 2019-09-30
• First posted: 2017-03-01
• Last updated: 2026-01-09
• Results posted: 2026-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study