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iBGStar, Traditional Glucometer · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| iBGStar (Group A) | EXPERIMENTAL | 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. |
| Traditional Glucometer (Group B) | ACTIVE_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| iBGStar | DEVICE | - |
| Traditional Glucometer | DEVICE | - |
Inclusion Criteria: * Type 1 diabetes * Males and females * Age between 14-24 years * Any diabetes duration * Cared for by the diabetes center for at least 1 year * HbA1c ≥ 8% * Basal bolus treatment (any insulin) * Poor compliance with Self-Monitoring of Blood Glucose (less than 30% of the recomme...
iBGStar is a traditional glucometer used for self-monitoring of blood glucose in people with diabetes mellitus. It is designed to help patients track their blood sugar levels as part of diabetes management.
iBGStar is developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is responsible for the development and commercialization of the device.
iBGStar has completed a Phase 3 clinical trial. The trial was a comparative study of a smartphone-linked self-monitoring system versus a traditional one for improving metabolic control and compliance to self-monitoring of blood glucose.
iBGStar was studied in a completed Phase 3 clinical trial with the identifier NCT02073188. The trial enrolled 186 participants with diabetes mellitus in Italy and compared the device to a traditional self-monitoring system.
Yes, the Phase 3 clinical trial for iBGStar was randomized and active-controlled. The study was not double-blind, meaning participants and investigators were aware of the treatment assignments during the trial.