Clinical trial NCT00643474: PRISMA Study (Prospective, Randomized Trial on Intensive Self-Monitoring Blood Glucose Management Added Value in Non-Insulin Treated Type 2 Diabetes Mellitus Patients)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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 \&gt;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

Primary outcomes:
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).
timeFrame: Visit 5 (52 weeks after Visit 1 +/- 2 weeks).
Secondary outcomes:
measure: 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.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Alessandria
country: Italy
city: Ancona
country: Italy
city: Asti
country: Italy
city: Bari
country: Italy
city: Bassano del Grappa
country: Italy
city: Bergamo
country: Italy
city: Cagliari
country: Italy
city: Catania
country: Italy
city: Catanzaro
country: Italy
city: Fermo
country: Italy
city: Foggia
country: Italy
city: Forlì
country: Italy
city: Genova
country: Italy
city: Lanusei
country: Italy
city: Mariano Comense
country: Italy
city: Messina
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Monfalcone
country: Italy
city: Napoli
country: Italy
city: Olbia
country: Italy
city: Padova
country: Italy
city: Palermo
country: Italy
city: Perugia
country: Italy
city: Pescara
country: Italy
city: Prato
country: Italy
city: Quartu S. Elena - Cagliari
country: Italy
city: Ravenna
country: Italy
city: Roma
country: Italy
city: Rome
country: Italy
city: Rome
country: Italy
city: Rome
country: Italy
city: Rovigo
country: Italy
city: S. Benedetto del Tronto (AP)
country: Italy
city: Salerno
country: Italy
city: Siena
country: Italy
city: Terni
country: Italy
city: Torino
country: Italy
city: Treviso
country: Italy
city: Trieste
country: Italy
city: Udine
country: Italy
city: Vicenza
country: Italy
Study officials:
affiliation: Roche Diagnostics S.p.A.
name: Raffaele Marino
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.