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

East Tennessee State University12 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

T2DM (Type 2 Diabetes Mellitus)Continuous Glucose Monitoring

Interventions

iPro2 Professional CGMDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

East Tennessee State University

Johnson City, Tennessee, United States

Outcomes

Primary Outcomes

Time Spent in Target Range

Time sensor glucose is between 70-140mg/dl during a 72 hour collection period

Time frame: 6 Months

Data from ClinicalTrials.gov

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