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

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

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.

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.

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)