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Diabetes Mellitus Type 2NCT00643474

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

A study testing Accu-Chek Aviva Meter in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 43 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 75 years
Conditions the study is for
Diabetes Mellitus Type 2
What is being tested?
Accu-Chek Aviva Meter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
43 sitesItaly
Study dates
Mar 2008to Jun 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 75 years
  • All sexes
  • Adult, Older adult

Who may be able to join

  • 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%

Who cannot join

  • 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

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

Italy43 sites

  • Study site

    Alessandria, 15100

  • Study site

    Ancona, 60131

  • Study site

    Asti, 14100

  • Study site

    Bari, 70124

  • Study site

    Bassano del Grappa, 36061

  • Study site

    Bergamo, 24128

  • Study site

    Cagliari, 09042

  • Study site

    Catania, 95122

  • Study site

    Catanzaro, 88100

  • Study site

    Fermo, 60023

  • Study site

    Foggia, 71100

  • Study site

    Forlì, 47034

  • Study site

    Genova, 16149

  • Study site

    Lanusei, 08045

  • Study site

    Mariano Comense, 22066

  • Study site

    Messina, 98126

  • Study site

    Milan, 20121

  • Study site

    Milan, 20132

  • Study site

    Milan, 20150

  • Study site

    Monfalcone, 34074

  • Study site

    Naples, 80131

  • Study site

    Olbia, 07026

  • Study site

    Padova, 35128

  • Study site

    Palermo, 90047

  • Study site

    Perugia, 06100

  • Study site

    Pescara, 65124

  • Study site

    Prato, 59100

  • Study site

    Quartu S. Elena - Cagliari, 09045

  • Study site

    Ravenna, 48100

  • Study site

    Roma, 00195

  • Study site

    Rome, 00100

  • Study site

    Rome, 00157

  • Study site

    Rome, 0151

  • Study site

    Rovigo, 45100

  • Study site

    S. Benedetto Del Tronto (AP), 63039

  • Study site

    Salerno, 84100

  • Study site

    Siena, 53100

  • Study site

    Terni, 05100

  • Study site

    Torino, 10126

  • Study site

    Treviso, 31100

  • Study site

    Trieste, 34148

  • Study site

    Udine, 33100

  • Study site

    Vicenza, 36100

Other trials in Italy

About this study

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.

Being tested
Accu-Chek Aviva Meter
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Accu-Chek Aviva MeterDevice

    4-point daily glucose monitoring profile 3 times per week

  • Accu-Chek Aviva MeterDevice

    Frequency and timing of SMBG not specified

Study groups in NCT00643474
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Device: Accu-Chek Aviva Meter
BExperimentalNot described
Receives: Device: Accu-Chek Aviva Meter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Visit 5 (52 weeks after Visit 1 +/- 2 weeks).

Secondary outcomes (1)

  1. 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.

    Measured: Throughout study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00643474
Sponsor's protocol ID
RD000577
Other IDs
RD0107
Status last verified
May 2010
First submitted
20 Mar 2008
Last updated
3 Mar 2016
Results posted
No

Publications

  • Russo GT, Scavini M, Acmet E, Bonizzoni E, Bosi E, Giorgino F, Tiengo A, Cucinotta D. The Burden of Structured Self-Monitoring of Blood Glucose on Diabetes-Specific Quality of Life and Locus of Control in Patients with Noninsulin-Treated Type 2 Diabetes: The PRISMA Study. Diabetes Technol Ther. 2016 Jul;18(7):421-8. doi: 10.1089/dia.2015.0358. Epub 2016 Jun 21.

    PubMed 27327185

  • Bosi E, Scavini M, Ceriello A, Cucinotta D, Tiengo A, Marino R, Bonizzoni E, Giorgino F; PRISMA Study Group. Intensive structured self-monitoring of blood glucose and glycemic control in noninsulin-treated type 2 diabetes: the PRISMA randomized trial. Diabetes Care. 2013 Oct;36(10):2887-94. doi: 10.2337/dc13-0092. Epub 2013 Jun 4.

    PubMed 23735724

  • Scavini M, Bosi E, Ceriello A, Giorgino F, Porta M, Tiengo A, Vespasiani G, Bottalico D, Marino R, Parkin C, Bonizzoni E, Cucinotta D. Prospective, randomized trial on intensive SMBG management added value in non-insulin-treated T2DM patients (PRISMA): a study to determine the effect of a structured SMBG intervention. Acta Diabetol. 2013 Oct;50(5):663-72. doi: 10.1007/s00592-011-0357-y. Epub 2011 Dec 22.

    PubMed 22189755

Questions about this trial

What is this clinical trial studying?

A study testing Accu-Chek Aviva Meter in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 43 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00643474, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2016.

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