Develop Novel Methods to Display, Report and Analyze CGM Data for Clinical Decision-Making in People With Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to obtain sufficient continuous glucose monitoring (CGM) data in a manner that provides clinical information that is not available using conventional self-monitored blood glucose. Currently, a formal method does not exist for evaluating CGM data except for looking at each glucose reading across the days a CGM system has been worn and evaluating it based on clinical practice experience. The hope is that a mathematical model can be developed that will enable health care providers to quickly and easily determine what changes in diabetes treatment need to be made after CGM data is obtained.

Detailed Description
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There are two purposes to the study. First, to use an investigational device, the FreeStyle Navigator Continuous Glucose Monitoring (CGM) System (Abbott Diabetes Care) to obtain sufficient longitudinal data in order to develop a method for reporting CGM data in a manner that provides clinical information that is not available using conventional SMBG. The long-term goad is to determine the manner and degree to which CGM contributes to clinical decision-making. Because of the evidence that glucose regulation may be indirectly related to blood pressure levels, a second purpose of the study is to monitor variation in BP control by means of self-monitored BP.

Official Title
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Observational Study of Interstitial Glucose Monitoring With the FreeStyle Navigator Continuous Glucose Monitoring (CGM) System to Develop Novel Methods for Displaying, Reporting and Analyzing CGM Data for Clinical Decision-Making

Conditions
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Diabetes, Glucose Variability, CGM

Intervention / Treatment
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* Device: CGM System for Type 1 and Type 2 Diabetes Mellitus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Diagnosed with type 1 or type 2 diabetes Treated with insulin therapy Can also be taking other diabetes medication treatment Age 21 and older Willing to give informed consent Capable of following the protocol and instructions of study staff Available for scheduled visits Access to telephone communications Exclusion Criteria: Under 21 years of age Unable to follow protocol Unable to read and write in English Skin abnormalities at insertion sites Allergy to adhesives Any concomitant medication thay would likely affect evaluation of device

Ages Eligible for Study
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Minimum Age: 21 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CGM System for Type 1 and Type 2 Diabetes Mellitus|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, CGM