To demonstrate the superiority of a chronic care model (SINERGIA model) supported by the Self Monitoring of Blood Glucose with BGStar over usual care in improving glycemic control at 12 months in patients with type 2 diabetes not treated with insulin.
The planned study duration is 36 months (9 quarters). The estimated duration of screening/enrollment will be 12 months, followed by the 12-month experimental phase, plus the 12-month follow-up in the observational phase.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
241
Investigational Site Number 016
Andria (BA), Italy
Investigational Site Number 011
Avezzano, Italy
Change in HbA1c levels from baseline
Time frame: baseline to 12 months
Percentage of participants with HbA1c ≤7.0%
Time frame: at 12 months and 24 months
Variation in body weight from baseline
Time frame: at 12 months and 24 months
Variation in waist circumference from baseline
Time frame: at 12 months and 24 months
Variation in blood pressure from baseline
Time frame: at 12 months and 24 months
Variation in lipid profile from baseline
Time frame: at 12 months and 24 months
Quality of life: SF12 (Health Survey) questionnaire
Time frame: at 12 months and 24 months
ADDQOL (Audit of Diabetes-Dependent Quality of Life)
Time frame: at 12 months and 24 months
DTSQ (Diabetes Treatment Satisfaction Questionnaire)
Time frame: at 12 months and 24 months
ABIM-14 (American Board of Internal Medicine satisfaction questionnaire)
Time frame: at 12 months and 24 months
PDM (Patient involvement in the Decision Making process) questionnaire
Time frame: at 12 months and 24 months
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Investigational Site Number 006
Bergamo, Italy
Investigational Site Number 002
Brescia, Italy
Investigational Site Number 022
Catania, Italy
Investigational Site Number 001
Cusano Milanino, Italy
Investigational Site Number 013
Livorno, Italy
Investigational Site Number 015
Lucca, Italy
Investigational Site Number 004
Mariano Comense, Italy
Investigational Site Number 017
Messina, Italy
...and 10 more locations
PHCO (Patient Health Care Orientation) questionnaire
Time frame: at 12 months and 24 months
Participants satisfaction with SMBG meter assessed by Visual Analog Scale (VAS)
Time frame: at 12 months and 24 months