NCT04211220

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
OTHER	A decision support software	Insulin pump Continuous glucose monitoring

Timeline

• Start date: 2020-01-09
• Primary completion: 2022-03-03
• Completion: 2022-03-03
• First posted: 2019-12-26
• Last updated: 2022-08-22

Locations

1 site across 1 country: France