Trial information
Intensive self-monitoring blood glucose management added value in non-insulin treated type 2 diabetes mellitus patients.
Status: Recruiting
Protocol number: RD000577
Company division: Diagnostic
Official Scientific Title: PRISMA Study (Prospective, randomized trial on intensive self-monitoring blood glucose management added value in non-insulin treated type 2 diabetes mellitus patients).
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 systemic/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 type: Interventional study
Condition: Diabetes Mellitus, Type 2
Intervention type: Device
Intervention name: AccuChek Aviva Meter
Primary outcome: 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).
Key secondary outcomes: Changes in HBGI and LBGI; change in blood glucose test frequency; change in blood glucose profile; change in diabetes therapy; change in urinary 8-isoPGF2α; changes in blood pressure, creatinine clearance, lipid profile and BMI; quality of life and Locus of Control analysis; frequency and severity of hypoglycemic episodes; study-related SAEs. Timeframe: Throughout study.
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.
Gender: Males or Females
Age limits: Min: 35 Years Max: 75 Years
Accepts healthy volunteers: No
Anticipated start date: March, 2008
Trial registration date: 03/20/2008
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Italy
- Ancona
- Asti
- Bari
- Bassano del Grappa
- Bergamo
- Catania
- Catanzaro
- Foggia
- Forli
- Genova
- Messina
- Milano
- Monfalcone
- Olbia
- Padova
- Palermo
- Perugia
- Pescara
- Prato
- Quartu S. Elena-Cagliari
- Roma
- S.Benedetto del Tronto (AP)
- Salerno
- Siena
- Terni
- Torino
- Udine
