Full Text View
Tabular View
No Study Results Posted
Related Studies
Intensive Self-Monitoring Blood Glucose Management Added Value in Non-Insulin Treated Type 2 Diabetes Mellitus Patients
This study is currently recruiting participants.
Verified by Hoffmann-La Roche, May 2008
First Received: March 20, 2008   Last Updated: January 9, 2009   History of Changes
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)

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 ]

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

Contacts
Contact: Please reference study ID number: RD000577 973-235-5000
Contact: or 800-526-6367 (FOR US ONLY)

Locations
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
Sponsors and Collaborators
Hoffmann-La Roche
  More Information

No publications provided

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

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

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

ClinicalTrials.gov processed this record on July 02, 2009