A Phase 3 interventional study of iBGStar and Traditional Glucometer in Diabetes Mellitus, sponsored by Sanofi. Completed at 1 site in Italy. Open to participants aged 14 Years to 24 Years. Per ClinicalTrials.gov, last updated 2016-04-14.
Sponsored by Sanofi · Phase 3 and Interventional
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 186 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Self-Monitoring Blood Glucose will be managed with iBGStar and iBGStar Diabetes Manager Application (App) uploaded on iPhone for all duration of the study (6 months of experimental phase plus 6-months of observational phase). In the first 3 months, the patients in Group A will send their glycemic test values and notes by mail to the physician through Diabetes Manager App every 2 weeks. Afterwards until the visit V2 (six months), the patients in Group A will send their glycemic test values and notes by mail monthly. 9 reports in total.
Device: iBGStar
Self-Monitoring Blood Glucose will be managed with a traditional glucometer according to usual care for the first 6 months (experimental phase). In the 6 months post-trial follow-up (observational phase), Self-Monitoring Blood Glucose will be managed with iBGStar and iBGStar Diabetes Manager App.
Device: Traditional Glucometer
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
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sanofi