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)”

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.

Study Type: Interventional

Study Design: Diagnostic, Randomized, Open Label, Parallel Assignment

Study Primary Completion Date: March 2010

Intervention(s) in this Clinical Trial

• Device: AccuChek Aviva Meter
  • 4-point daily glucose monitoring profile 3 times per week
• Device: AccuChek Aviva Meter
  • Frequency and timing of SMBG not specified

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2

Primary Measures

• 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).
  • Time Frame: Visit 5 (52 weeks after visit 1 +/- 2 weeks).
    Safety Issue?: No

Secondary Measures

• 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.
  • Time Frame: Throughout study
    Safety Issue?: No

Inclusion Criteria:

• adult patients, 35-75 years of age;
• non-insulin treated type 2 diabetes for 1-10 years before enrollment;
• treatment with diet and oral hypoglycemic agents, or with diet only;
• HbAlc of 7.0-9.0%

Exclusion Criteria:

• type 1 diabetes;
• insulin treatment (for >7 consecutive days);
• previous intensive SMBG management (the execution of SMBG measurements used to modify lifestyle, diet or physical activity in a systemic/structured manner and/or to manage therapeutic approach);
• impending complications of diabetes;
• serious diseases, including cardiovascular damage or limited life expectancy;
• pregnancy.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 35 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hoffmann-La Roche

Overall Clinical Trial Officials and Contacts

Overall Contact: Please reference study ID number: RD000577 973-235-5000 

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00643474

Study ID Number: RD000577

ClinicalTrials.gov Identifier: NCT00643474

Health Authority: Italy: Osservatorio Nazionale sulla Sperimentazione Clinica