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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

NCT02082028

CompletedNA

Sponsor: Sanofi

Conditions: Diabetes Mellitus

Interventions: BGStar, glucose meter

Countries: Italy

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.

Eligibility overview

Sex: ALL

Age: 45 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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)

Locations (20)

Andria (BA), Italy
Avezzano, Italy
Bergamo, Italy
Brescia, Italy
Catania, Italy
Cusano Milanino, Italy
Livorno, Italy
Lucca, Italy
Mariano Comense, Italy
Messina, Italy
Milan, Italy
Naples, Italy
Potenza, Italy
Ragusa, Italy
Ravenna, Italy
Rimini, Italy
Roma, Italy
Terlizzi (BA), Italy
Torino, Italy
Udine, Italy