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Study to Assess the Metabolic Impact of IRTA© and Patients Satisfaction in Type 1 Diabetic Patients, Treated by Either Insulin Pump or Multiple Daily Insulin Injections, and Using Freestyle Libre®, a Real-time Continuous Glucose Monitoring — IRTA  

Type 1 Diabetes Clinical Trial

Official title:
Clinical Evaluation of Insulin Real-Time Advisor (IRTA©): a Decision Support Software for Insulin Therapy Combined With Freestyle Libre®, a Continuous Glucose Monitoring System: Glycemic Impact and Satisfaction in Type 1 Diabetic Patients

Clinical Trial 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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04211220
Study type Interventional
Source Rennes University Hospital
Contact
Status Completed
Phase N/A
Start date January 9, 2020
Completion date March 3, 2022
View Details
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