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

Sponsor:	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: 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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Dextrose Proparacaine Proparacaine hydrochloride

U.S. FDA Resources

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
Estimated Study Completion Date:	June 2011
Estimated 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
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

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

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00643474 History of Changes
Other Study ID Numbers:	RD000577, RD0107
Study First Received:	March 20, 2008
Last Updated:	March 15, 2011
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 February 12, 2012