Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02073188 | 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 | PHASE3 | COMPLETED | 186 | — | — | Jun 1, 2012 | Sep 1, 2014 | Apr 14, 2016 | 1 | Italy |
| 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...