MedTrace Logo

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

NCT00643474 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2016-03-03

No results posted yet for this study

Summary

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.

Conditions

  • Diabetes Mellitus Type 2

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Raffaele Marino · Roche Diagnostics S.p.A.

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00643474 on ClinicalTrials.gov