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

March 1, 2016 updated by: Hoffmann-La Roche
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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, 00100
      • Rome, Italy, 00157
      • Rome, Italy, 0151
      • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
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
Experimental: B
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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).
Visit 5 (52 weeks after Visit 1 +/- 2 weeks).

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Raffaele Marino, Roche Diagnostics S.p.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

March 20, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Estimate)

March 3, 2016

Last Update Submitted That Met QC Criteria

March 1, 2016

Last Verified

May 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD000577
  • RD0107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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