Modal Day Analysis of Self Monitoring Blood Glucose Versus Continuous Glucose Monitoring

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of Self Monitoring of Blood Glucose (SMBG) for clinical decisions related to the management of type 2 diabetes and to determine the benefit of using Continuous Glucose Monitoring (CGM) for clinical diabetes management.

Official Title
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Optimization of SMBG Employing Modal Day Analysis: Examining Clinical Decision-making Processes Using Blinded FreeStyle Navigator Continuous Glucose Monitoring System (CGM)

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: SMBG to guide clinical decisions
* Other: SMBG and CGM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects ≥18 and ≤75 years of age Clinical diagnosis of diabetes Diabetes duration ≥ 1 year HbA1c ≥7.2% Diabetes can be treated with any therapy including medical nutrition therapy alone and any pharmaceutical therapy Exclusion Criteria: Taken prednisone or cortisone medications in the previous 30 days Currently pregnant or planning pregnancy during the study period Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study Unable to follow the study protocol Unable to speak, read and write in English

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SMBG Only<br>You will measure your blood glucose 4 times daily by finger sticks using a blood glucose meter and you will also wear a CGM device. The CGM measurements will be blinded (neither you nor the study doctor will be able to see the CGM measurements until your final study visit). Only your SMBG measurements will be considered to help manage your diabetes. Your medications will be changed or adjusted based on your HbA1c and/or glucose readings with a goal to achieve an HbA1c level of less than 7%. | Other: SMBG to guide clinical decisions<br>* The investigator will base clinical decisions on A1c and modal day analysis of SMBG.<br>|
| Active Comparator: SMBG and CGM<br>You will measure your blood glucose 4 times daily by finger sticks using a blood glucose meter and you will also wear a CGM device. The CGM measurements will be downloaded at each study visit and will be considered along with your SMBG measurements to help manage your diabetes. Your medications will be changed or adjusted based on your HbA1c and/or glucose readings with a goal to achieve an HbA1c level of 7%. | Other: SMBG and CGM<br>* The investigator will base clinical decisions on A1c, modal day analysis of SMBG and CGM data.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the efficacy of SMBG for clinical decisions related to the management of type 2 diabetes. |  | Three, six and nine months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the incremental benefit of CGM for clinical decision-making. |  | Three, six and nine months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes, A1c, Continuous Glucose Monitoring, Blood Glucose