Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-25 @ 4:11 AM
Ignite Modification Date: 2025-12-25 @ 4:11 AM
NCT ID: NCT04211220
Brief Summary: A prospective monocentric " before and after " study, ruled in 2 periods of 3 months : during the first period, the patient will adjust insulin treatment as usual, during the second period, the patient will adjust insulin treatment with IRTA support
Detailed Description: Freestyle Libre® continuous glucose monitoring (CGM) system may improve glycemic control. However, this system contributes to the complexity of insulin adjustment by the diversity of the data delivered by CGM system. Insulin Real-Time Advisor (IRTA©), a decision support software, has been developed in order to guide patients in the adaptation of their treatment according to CGM data. IRTA© provides advice applicable to thousand situations according to six parameters: glucose level, trend arrows, meals, physical activity, before bedtime, time since the previous bolus. Type of advice : * Insulin injection (carb and correction) * To continue treatment without modification * To lower the insulin dose (temporary basal rate) * Sugar intake advice * Glucose level control with CGM, self-monitor blood glucose, blood ketones monitor * To change catheter for patients treated by insulin pump.
Study: NCT04211220
Study Brief:
Protocol Section: NCT04211220