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

NCT ID: NCT03067480

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-06
• Study Completion Date: 2019-09-30

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.

Conditions

T2DM (Type 2 Diabetes Mellitus); Continuous Glucose Monitoring

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

iPro2 Professional CGM

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

iPro2 Professional CGM

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

East Tennessee State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rick Hess, PharmD

Role: PRINCIPAL_INVESTIGATOR

East Tennessee State University

Locations

East Tennessee State University

Johnson City, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ETSU

Identifier Type: -

Identifier Source: org_study_id