Effect of Real Time Continuous Glucose Monitoring System on the Management of Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the Guardian Continuous Glucose Monitoring System in the home setting is more useful than frequent self blood glucose monitoring with a view to modifying patient's diet and exercise habits or improvement self disease control efforts and at last glycemic control in patients with type 2 diabetes

Detailed Description
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In diabetes management, compliance, disease awareness and empowerment of the patient play an important role and the immediate feedback on the effects of diet and exercise that the self monitoring blood glucose (SMBG) may provide, could enhance patient empowerment. Increased use of SMBG has been shown to be associated with improved medication compliance and better metabolic control by several studies. However, because of many factors, including pain and inconvenience, many diabetic patients do not accept frequent fingersticks for self blood glucose monitoring (SBGM) levels. In addition, the SBGM result gives the data for only a few seconds, without any information on glucose trends. So we need new glucose monitoring method that could reflect glucose trends and glycemic excursion continuously because glucose monitoring still remains the cornerstone of evaluating the efficacy of therapy and motivating self disease control in subjects with diabetes. Few studies have examined the effects of real time continuous glucose monitoring system targeting type 2 diabetes. So our goal is to determine whether the Guardian Continuous Glucose Monitoring System in the home setting is more useful than frequent self blood glucose monitoring with a view to modifying patient's diet and exercise habits or improvement self disease control efforts and at last glycemic control in patients with type 2 diabetes

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Device: Guardian RT
* Behavioral: Education about the self monitoring blood glucose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes Group 1: HbA1c < 8% with a stable insulin or oral hypoglycemic agents (OHA) regimen for the prior 2 months with no plans to switch modality of insulin or OHA administration during the next 3months. Group 2: HbA1c >= 8% and the fasting blood glucose must be < 130 at the same time with a stable insulin or oral hypoglycemic agents (OHA) regimen for the prior 2 months with no plans to switch modality of insulin or OHA administration during the next 3months Exclusion Criteria: Use of corticosteroids or hormone therapy within the last 6 months Presence of another chronic illness

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Guardina RT monitoring | Device: Guardian RT<br> <br> |
| Active Comparator: B<br> | Behavioral: Education about the self monitoring blood glucose<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c, fasting blood glucose level, weight change, blood pressure in the morning, lipid profiles |  | basline, 12weeks later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| three day diary meals and seven day physical activity diary |  | basline, 12 weeks later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glucose monitoring system, life style intervention