The purpose of this study is to demonstrate the superiority of iBGstar as a component of the diabetes treatment vs. traditional blood glucose self-monitoring system for improving glycemic control after 6 months in young patients with type 1 diabetes. The study is intended also to demonstrate the superiority of iBGStar as a component of the diabetes treatment vs. usual blood glucose self-monitoring system for improving the compliance to self monitoring of blood glucose after 6 months.
The planned study duration will be 20 months (5 quarters) with screening/enrollment of 7 months, followed by 2-3 weeks of a qualification phase, a 6 month experimental phase, plus a 6 month follow-up in the post-trial observational phase.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
186
Sanofi -Aventis Administrative Office
Milan, Italy
Change in HbA1c levels from baseline
Time frame: baseline to six months
Proportion of participants performing at least 30% of the recommended Self-Monitoring Blood Glucose tests after 6 months from randomization
Time frame: at 6 months
Percentage of participants with HbA1c ≤7.5%
Time frame: at 6 months and 12 months
Average number of recommended Self-Monitoring Blood Glucose tests daily, weekly, and monthly
Time frame: at 6 months and 12 months
Mean fasting plasma glucose (FPG) and postprandial glucose (PPG)
Time frame: at 6 months and 12 months
Mean Glycemic Variability
Time frame: at 6 months and 12 months
Average Insulin Dose
Time frame: at 6 months and 12 months
Number of Daily Injections
Time frame: at 6 months and 12 months
Number of Insulin Dose Adjustments
Time frame: at 6 months and 12 months
Quality of life: Audit of Diabetes Dependent Quality of Life (ADDQOL) (young adults 18-24 years)
Time frame: at 6 months and 12 months
Diabetes Quality of Life (DQOL-Y) (adolescents 14-17 years)
Time frame: at 6 months and 12 months
Participants satisfaction with SMBG meter assessed by Visual Analog Scale (VAS)
Time frame: at 6 months and 12 months
Number overall contacts between centers and participants
Time frame: up to 12 months
Type of overall contacts between centers and participants
Time frame: up to 12 months
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