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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,000
4-point daily glucose monitoring profile 3 times per week
Frequency and timing of SMBG not specified
Unnamed facility
Alessandria, Italy
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Ancona, Italy
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Asti, Italy
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Bari, Italy
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Bassano del Grappa, Italy
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Bergamo, Italy
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Cagliari, Italy
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Catania, Italy
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Catanzaro, Italy
Unnamed facility
Fermo, Italy
...and 33 more locations
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).
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
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