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

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.

Study Overview

• Status: Terminated
• Conditions: T2DM (Type 2 Diabetes Mellitus); Continuous Glucose Monitoring
• Intervention / Treatment: Device: iPro2 Professional CGM

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Johnson City, Tennessee, United States, 37614
      • East Tennessee State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3-Month 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.	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.
Experimental: 6-Month 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Spent in Target Range	Time sensor glucose is between 70-140mg/dl during a 72 hour collection period	6 Months

Collaborators and Investigators

• Sponsor: East Tennessee State University
• Collaborators: Medtronic
• Investigators: Principal Investigator: Rick Hess, PharmD, East Tennessee State University

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2017
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: February 24, 2017
• First Submitted That Met QC Criteria: February 24, 2017
• First Posted (Actual): March 1, 2017

Study Record Updates

• Last Update Posted (Estimated): January 9, 2026
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: ETSU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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