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: June 10, 2014
Last verified: May 2010
  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 (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.


Condition Intervention
Diabetes Mellitus, Type 2
Device: Accu-Chek Aviva Meter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome 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). ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Enrollment: 1000
Study Start Date: March 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Device: Accu-Chek Aviva Meter
4-point daily glucose monitoring profile 3 times per week
Experimental: B Device: Accu-Chek Aviva Meter
Frequency and timing of SMBG not specified

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643474

Locations
Italy
Alessandria, Italy, 15100
Ancona, Italy, 60131
Asti, Italy, 14100
Bari, Italy, 70124
Bassano Del Grappa, Italy, 36061
Bergamo, Italy, 24128
Cagliari, Italy, 09042
Catania, Italy, 95122
Catanzaro, Italy, 88100
Fermo, Italy, 60023
Foggia, Italy, 71100
Forlì, Italy, 47034
Genova, Italy, 16149
Lanusei, Italy, 08045
Mariano Comense, Italy, 22066
Messina, Italy, 98126
Milano, Italy, 20132
Milano, Italy, 20121
Milano, Italy, 20150
Monfalcone, Italy, 34074
Napoli, Italy, 80131
Olbia, Italy, 07026
Padova, Italy, 35128
Palermo, Italy, 90047
Perugia, Italy, 06100
Pescara, Italy, 65124
Prato, Italy, 59100
Quartu S. Elena - Cagliari, Italy, 09045
Ravenna, Italy, 48100
Roma, Italy, 00195
Rome, Italy, 00157
Rome, Italy, 0151
Rome, Italy, 00100
Rovigo, Italy, 45100
S. Benedetto Del Tronto (ap), Italy, 63039
Salerno, Italy, 84100
Siena, Italy, 53100
Terni, Italy, 05100
Torino, Italy, 10126
Treviso, Italy, 31100
Trieste, Italy, 34148
Udine, Italy, 33100
Vicenza, Italy, 36100
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Raffaele Marino Roche Diagnostics S.p.A.
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00643474     History of Changes
Other Study ID Numbers: RD000577, RD0107
Study First Received: March 20, 2008
Last Updated: June 10, 2014
Health Authority: Italy: Osservatorio Nazionale sulla Sperimentazione Clinica

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 29, 2014