Intensive Self-Monitoring Blood Glucose Management Added Value in Non-Insulin Treated Type 2 Diabetes Mellitus Patients - Full Text View

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

MedlinePlus related topics:

Diabetes

ChemIDplus related topics:

Dextrose

U.S. FDA Resources

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)

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

Responsible Party:	Hoffmann-La Roche ( Study Director )
Study ID Numbers:	RD000577, RD0107
First Received:	March 20, 2008
Last Updated:	May 7, 2008
ClinicalTrials.gov Identifier:	NCT00643474
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

Metabolic disorder

Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00643474