PRISMA Study (Prospective, Randomized Trial on Intensive Self-Monitoring Blood Glucose Management Added Value in Non-Insulin Treated Type 2 Diabetes Mellitus Patients)
2 other identifiers
interventional
1,000
1 country
43
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Mar 2008
Longer than P75 for not_applicable diabetes-mellitus-type-2
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 20, 2008
CompletedFirst Posted
Study publicly available on registry
March 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedMarch 3, 2016
May 1, 2010
3.3 years
March 20, 2008
March 1, 2016
Conditions
Outcome Measures
Primary Outcomes (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).
Visit 5 (52 weeks after Visit 1 +/- 2 weeks).
Secondary Outcomes (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.
Throughout study
Study Arms (2)
A
EXPERIMENTALB
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Unknown Facility
Alessandria, 15100, Italy
Unknown Facility
Ancona, 60131, Italy
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Asti, 14100, Italy
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Bari, 70124, Italy
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Bassano del Grappa, 36061, Italy
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Bergamo, 24128, Italy
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Cagliari, 09042, Italy
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Catania, 95122, Italy
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Catanzaro, 88100, Italy
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Fermo, 60023, Italy
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Foggia, 71100, Italy
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Forlì, 47034, Italy
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Genova, 16149, Italy
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Lanusei, 08045, Italy
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Mariano Comense, 22066, Italy
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Messina, 98126, Italy
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Milan, 20121, Italy
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Milan, 20132, Italy
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Milan, 20150, Italy
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Monfalcone, 34074, Italy
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Napoli, 80131, Italy
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Olbia, 07026, Italy
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Padua, 35128, Italy
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Palermo, 90047, Italy
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Perugia, 06100, Italy
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Pescara, 65124, Italy
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Prato, 59100, Italy
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Quartu S. Elena - Cagliari, 09045, Italy
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Ravenna, 48100, Italy
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Roma, 00195, Italy
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Rome, 00100, Italy
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Rome, 00157, Italy
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Rome, 0151, Italy
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Rovigo, 45100, Italy
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S. Benedetto Del Tronto (AP), 63039, Italy
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Salerno, 84100, Italy
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Siena, 53100, Italy
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Terni, 05100, Italy
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Torino, 10126, Italy
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Treviso, 31100, Italy
Unknown Facility
Trieste, 34148, Italy
Unknown Facility
Udine, 33100, Italy
Unknown Facility
Vicenza, 36100, Italy
Related Publications (3)
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.
PMID: 27327185DERIVEDBosi 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.
PMID: 23735724DERIVEDScavini 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.
PMID: 22189755DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Raffaele Marino
Roche Diagnostics S.p.A.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2008
First Posted
March 26, 2008
Study Start
March 1, 2008
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
March 3, 2016
Record last verified: 2010-05