Efficacy of a Chronic Care Model Supported by Self Monitoring of Blood Glucose With BGStar Over Usual Care in Improving Glycemic Control in Patients With Type 2 Diabetes Not Treated With Insulin

Study Overview
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Brief Summary
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To demonstrate the superiority of a chronic care model (SINERGIA model) supported by the Self Monitoring of Blood Glucose with BGStar over usual care in improving glycemic control at 12 months in patients with type 2 diabetes not treated with insulin.

Detailed Description
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The planned study duration is 36 months (9 quarters). The estimated duration of screening/enrollment will be 12 months, followed by the 12-month experimental phase, plus the 12-month follow-up in the observational phase.

Official Title
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Randomized Clinical Trial on the Efficacy of Self-Monitoring Blood Glucose in the Context of a Chronic Care Model for Type 2 Diabetes Patients Treated With Oral Agents Only

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: BGStar
* Device: glucose meter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females Age ≥ 45 years Type 2 diabetes First access at the diabetes clinic Any diabetes duration HbA1c >7.0 and ≤ 9.0% Already treated with any oral antidiabetic agent (OAD) or requiring the initiation of therapy with OAD Patients not using SMBG or using SMBG with a frequency ≤1 test/week Written informed consent Exclusion Criteria: Treatment with insulin or need to start insulin regimens or continuous sub-cutaneous insulin infusion at the first access; Refusal or inability to give informed consent to participate in the study; Conditions / situations such as: Patients with short life expectancy; Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint according to physician's judgment; Requirement for concomitant treatment that could bias primary evaluation (i.e. corticosteroid treatment); Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other study site staff or relative of study site staff thus considered directly involved in the conduct of the study; Current addition/abuse of alcohol or drugs; Patients with any mental condition rendering them unable to understand the nature, scope, and possible consequences of the study; Pregnant or breast-feeding women; Patients living too far from investigational center or other conditions reducing the adherence to the protocol; Subjects unlikely or unable to comply with the Protocol requirements (e.g. illiterate, uncooperative, unable to return for follow-up visit, unable to use BGStar unlikely to complete the study)

Ages Eligible for Study
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Minimum Age: 45 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A (BGStar)<br>Patients will be educated within the context of the SINERGIA educational program to understand how to manage their own diabetes on the basis of their Self Monitoring of Blood Glucose values obtained with BGStar. Patients will be requested two 6-points profiles monthly. | Device: BGStar<br> <br> |
| Active Comparator: B (traditional approach)<br>Usual approach for the disease management. Patients in Group B will receive usual education and, at any time during the study duration, if needed, will be instructed on Self Monitoring of Blood Glucose, performed with any glucose meter. | Device: glucose meter<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c levels from baseline |  | baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with HbA1c ≤7.0% |  | at 12 months and 24 months | 
| Variation in body weight from baseline |  | at 12 months and 24 months | 
| Variation in waist circumference from baseline |  | at 12 months and 24 months | 
| Variation in blood pressure from baseline |  | at 12 months and 24 months | 
| Variation in lipid profile from baseline |  | at 12 months and 24 months | 
| Quality of life: SF12 (Health Survey) questionnaire |  | at 12 months and 24 months | 
| ADDQOL (Audit of Diabetes-Dependent Quality of Life) |  | at 12 months and 24 months | 
| DTSQ (Diabetes Treatment Satisfaction Questionnaire) |  | at 12 months and 24 months | 
| ABIM-14 (American Board of Internal Medicine satisfaction questionnaire) |  | at 12 months and 24 months | 
| PDM (Patient involvement in the Decision Making process) questionnaire |  | at 12 months and 24 months | 
| PHCO (Patient Health Care Orientation) questionnaire |  | at 12 months and 24 months | 
| Participants satisfaction with SMBG meter assessed by Visual Analog Scale (VAS) |  | at 12 months and 24 months |