PRISMA Study (Prospective, Randomized Trial on Intensive Self-Monitoring Blood Glucose Management Added Value in Non-Insulin Treated Type 2 Diabetes Mellitus Patients)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00643474
First received: March 20, 2008
Last updated: August 26, 2014
Last verified: May 2010

March 20, 2008
August 26, 2014
March 2008
June 2011   (final data collection date for primary outcome measure)
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). ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00643474 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
PRISMA Study (Prospective, Randomized Trial on Intensive Self-Monitoring Blood Glucose Management Added Value in Non-Insulin Treated Type 2 Diabetes Mellitus Patients)
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 (Intens ive Group) will perform a 4-point daily glucose monitoring profile 3 times a wee k Monnier-based. These patients will also receive specific glycemic targets and suggestions on how to reach them following lifestyle recommendations. At the sam e time, investigators will use SMBG results, downloaded from glucometers, to imp rove patients' therapy. The second group (Control Group), will follow the SMBG s tandard care usually adopted in their centers. To be eligible, patients do not t

o have performed a previous intensive SMBG management (the execution of SMBG mea surements used to modify lifestyle, diet or physical activity, in a systematic/s tructured manner and/or to manage therapeutic approach). The anticipated duratio n of the trial is 12 months, and the target sample size is 1000 individuals.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Diabetes Mellitus, Type 2
  • Device: Accu-Chek Aviva Meter
    4-point daily glucose monitoring profile 3 times per week
  • Device: Accu-Chek Aviva Meter
    Frequency and timing of SMBG not specified
  • Experimental: A
    Intervention: Device: Accu-Chek Aviva Meter
  • Experimental: B
    Intervention: Device: Accu-Chek Aviva Meter

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
June 2011
June 2011   (final data collection date for primary outcome measure)

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 &gt;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
Both
35 Years to 75 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00643474
RD000577, RD0107
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Raffaele Marino Roche Diagnostics S.p.A.
Hoffmann-La Roche
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP