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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (BGStar) | Experimental | 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. |
|
| B (traditional approach) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGStar | Device |
| ||
| glucose meter |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c levels from baseline | baseline to 12 months |
| 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 |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Science & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 016 | Andria (BA) | Italy | ||||
| Investigational Site Number 011 |
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|
| 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 |
| Avezzano |
| Italy |
| Investigational Site Number 006 | Bergamo | 24128 | Italy |
| Investigational Site Number 002 | Brescia | Italy |
| Investigational Site Number 022 | Catania | 95122 | Italy |
| Investigational Site Number 001 | Cusano Milanino | Italy |
| Investigational Site Number 013 | Livorno | Italy |
| Investigational Site Number 015 | Lucca | Italy |
| Investigational Site Number 004 | Mariano Comense | Italy |
| Investigational Site Number 017 | Messina | Italy |
| Investigational Site Number 008 | Milan | Italy |
| Investigational Site Number 018 | Naples | Italy |
| Investigational Site Number 021 | Potenza | Italy |
| Investigational Site Number 020 | Ragusa | Italy |
| Investigational Site Number 014 | Ravenna | Italy |
| Investigational Site Number 012 | Rimini | 47900 | Italy |
| Investigational Site Number 009 | Roma | Italy |
| Investigational Site Number 019 | Terlizzi (BA) | Italy |
| Investigational Site Number 007 | Torino | Italy |
| Investigational Site Number 003 | Udine | Italy |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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