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| ID | Type | Description | Link |
|---|---|---|---|
| RD0107 |
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This randomized, parallel study compares 2 groups of type 2 non-insulin treated (NIT) diabetes patients using the Accu-Chek Aviva glucometers. One group (Intensive Group) will perform a 4-point daily glucose monitoring profile 3 times a week Monnier-based. These patients will also receive specific glycemic targets and suggestions on how to reach them following lifestyle recommendations. At the same time, investigators will use SMBG results, downloaded from glucometers, to improve patients' therapy. The second group (Control Group), will follow the SMBG standard care usually adopted in their centers. To be eligible, patients do not to have performed a previous intensive SMBG management (the execution of SMBG measurements used to modify lifestyle, diet or physical activity, in a systematic/structured manner and/or to manage therapeutic approach). The anticipated duration of the trial is 12 months, and the target sample size is 1000 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accu-Chek Aviva Meter | Device | 4-point daily glucose monitoring profile 3 times per week |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbAlc level; percentage of subjects reaching or maintaining the risk target (represented by a combination of LBGI<=2.5 together with HBGI<=5). | Visit 5 (52 weeks after Visit 1 +/- 2 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in HBGI & LBGI; blood glucose test frequency, blood glucose profile, diabetes therapy, urinary 8-isoPGF2alpha, blood pressure, creatinine clearance, lipid profile & BMI; QoL & Locus of Control analysis; hypoglycemic episodes; study-related SAEs. | Throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raffaele Marino | Roche Diagnostics S.p.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alessandria | 15100 | Italy | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27327185 | Derived | Russo GT, Scavini M, Acmet E, Bonizzoni E, Bosi E, Giorgino F, Tiengo A, Cucinotta D. The Burden of Structured Self-Monitoring of Blood Glucose on Diabetes-Specific Quality of Life and Locus of Control in Patients with Noninsulin-Treated Type 2 Diabetes: The PRISMA Study. Diabetes Technol Ther. 2016 Jul;18(7):421-8. doi: 10.1089/dia.2015.0358. Epub 2016 Jun 21. | |
| 23735724 |
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| Accu-Chek Aviva Meter |
| Device |
Frequency and timing of SMBG not specified |
|
| Ancona |
| 60131 |
| Italy |
| Asti | 14100 | Italy |
| Bari | 70124 | Italy |
| Bassano del Grappa | 36061 | Italy |
| Bergamo | 24128 | Italy |
| Cagliari | 09042 | Italy |
| Catania | 95122 | Italy |
| Catanzaro | 88100 | Italy |
| Fermo | 60023 | Italy |
| Foggia | 71100 | Italy |
| Forlì | 47034 | Italy |
| Genova | 16149 | Italy |
| Lanusei | 08045 | Italy |
| Mariano Comense | 22066 | Italy |
| Messina | 98126 | Italy |
| Milan | 20121 | Italy |
| Milan | 20132 | Italy |
| Milan | 20150 | Italy |
| Monfalcone | 34074 | Italy |
| Naples | 80131 | Italy |
| Olbia | 07026 | Italy |
| Padova | 35128 | Italy |
| Palermo | 90047 | Italy |
| Perugia | 06100 | Italy |
| Pescara | 65124 | Italy |
| Prato | 59100 | Italy |
| Quartu S. Elena - Cagliari | 09045 | Italy |
| Ravenna | 48100 | Italy |
| Roma | 00195 | Italy |
| Rome | 00100 | Italy |
| Rome | 00157 | Italy |
| Rome | 0151 | Italy |
| Rovigo | 45100 | Italy |
| S. Benedetto Del Tronto (AP) | 63039 | Italy |
| Salerno | 84100 | Italy |
| Siena | 53100 | Italy |
| Terni | 05100 | Italy |
| Torino | 10126 | Italy |
| Treviso | 31100 | Italy |
| Trieste | 34148 | Italy |
| Udine | 33100 | Italy |
| Vicenza | 36100 | Italy |
| Bosi E, Scavini M, Ceriello A, Cucinotta D, Tiengo A, Marino R, Bonizzoni E, Giorgino F; PRISMA Study Group. Intensive structured self-monitoring of blood glucose and glycemic control in noninsulin-treated type 2 diabetes: the PRISMA randomized trial. Diabetes Care. 2013 Oct;36(10):2887-94. doi: 10.2337/dc13-0092. Epub 2013 Jun 4. |
| 22189755 | Derived | Scavini M, Bosi E, Ceriello A, Giorgino F, Porta M, Tiengo A, Vespasiani G, Bottalico D, Marino R, Parkin C, Bonizzoni E, Cucinotta D. Prospective, randomized trial on intensive SMBG management added value in non-insulin-treated T2DM patients (PRISMA): a study to determine the effect of a structured SMBG intervention. Acta Diabetol. 2013 Oct;50(5):663-72. doi: 10.1007/s00592-011-0357-y. Epub 2011 Dec 22. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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