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| Sponsored by: |
Hoffmann-La Roche |
|---|---|
| Information provided by: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00643474 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes Mellitus, Type 2 |
Device: AccuChek Aviva Meter |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Open Label, Parallel Assignment |
| Official Title: | PRISMA Study (Prospective, Randomized Trial on Intensive Self-Monitoring Blood Glucose Management Added Value in Non-Insulin Treated Type 2 Diabetes Mellitus Patients) |
| Estimated Enrollment: | 1000 |
| Study Start Date: | March 2008 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Device: AccuChek Aviva Meter
4-point daily glucose monitoring profile 3 times per week
|
| 2: Experimental |
Device: AccuChek Aviva Meter
Frequency and timing of SMBG not specified
|
Eligibility| Ages Eligible for Study: | 35 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Please reference study ID number: RD000577 | 973-235-5000 | |
| Contact: or | 800-526-6367 (FOR US ONLY) |
| Italy | |
| Recruiting | |
| Ancona, Italy | |
| Recruiting | |
| Asti, Italy | |
| Recruiting | |
| Bari, Italy | |
| Recruiting | |
| Bassano del Grappa, Italy | |
| Recruiting | |
| Bergamo, Italy | |
| Recruiting | |
| Catania, Italy | |
| Recruiting | |
| Catanzaro, Italy | |
| Recruiting | |
| Foggia, Italy | |
| Recruiting | |
| Forli, Italy | |
| Recruiting | |
| Genova, Italy | |
| Recruiting | |
| Messina, Italy | |
| Recruiting | |
| Milano, Italy | |
| Recruiting | |
| Monfalcone, Italy | |
| Recruiting | |
| Udine, Italy | |
| Recruiting | |
| Padova, Italy | |
| Recruiting | |
| Palermo, Italy | |
| Recruiting | |
| Perugia, Italy | |
| Recruiting | |
| Pescara, Italy | |
| Recruiting | |
| Prato, Italy | |
| Recruiting | |
| Quartu S. Elena-Cagliari, Italy | |
| Recruiting | |
| Roma, Italy | |
| Recruiting | |
| S. Benedetto del Tronto (AP), Italy | |
| Recruiting | |
| Salerno, Italy | |
| Recruiting | |
| Siena, Italy | |
| Recruiting | |
| Terni, Italy | |
| Recruiting | |
| Torino, Italy | |
| Recruiting | |
| Olbia, Italy | |
More Information
| Responsible Party: | Hoffmann-La Roche ( Study Director ) |
| Study ID Numbers: | RD000577, RD0107 |
| Study First Received: | March 20, 2008 |
| Last Updated: | January 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00643474 History of Changes |
| Health Authority: | Italy: Osservatorio Nazionale sulla Sperimentazione Clinica |
|
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
|
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |