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| Name | Class |
|---|---|
| LifeScan | INDUSTRY |
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The aim of this pilot study is to evaluate the validity and feasibility of an educational approach involving nurses, combined with SMBG, aimed at lifestyle modification and timely changes in therapy, when needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMBG + intensive education | Experimental | Patients will receive specific educational interventions to teach them how to perform Self monitoring Blood Glucose (SMBG), how to modify diet and level of physical activity according to blood glucose levels, and the actions to be undertaken in case of abnormal values (hypoglycemia, particularly elevated glucose levels). Patients will be instructed to modify their lifestyle habits (diet, physical activity) in order to reach specific goals (weight reduction, reduction in fat consumption intake, reduction in saturated fat intake, increase in fiber intake, regular physical activity. |
|
| Usual Care | No Intervention | Usual Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMBG plus intensive education | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of metabolic control | Aim of this study is to evaluate the efficacy of Self Monitoring Blood Glucose and Intensive Education in terms of improvement of metabolic control expressed as HbA1c levels after 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in prandial Blood Glucose excursions | ||
| Percentage of patients needing therapy modifications | ||
| Percentage of patients reaching target HbA1c (i.e. <7.0%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Nicolucci, MD | Consorzio Mario Negri Sud | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consorzio Mario Negri Sud | Santa Maria Imbaro | Chieti | 66030 | Italy |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| 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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