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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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T2DM (Type 2 Diabetes Mellitus), Continuous Glucose Monitoring

Intervention / Treatment
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* Device: iPro2 Professional CGM


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3-Month iPro2 Professional CGM<br>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<br>* 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.<br>|
| Experimental: 6-Month iPro2 Professional CGM<br>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<br>* 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.<br>|

What is the study measuring?
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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 |