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
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
64
Insulin pump Continuous glucose monitoring
CHU de Rennes
Rennes, France
Percentage of time spent in 70-180mg/dl (time in range) in the last month of each period of the study (without and then with IRTA©)
Assessment of the metabolic impact of IRTA© on "time in range" (time spent in the standard glucose range between 70-180mg/dl, ie 3.9-10mmol/l) in type 1 diabetic patients, treated by either insulin pump or multiple daily insulin injections, and using Freestyle Libre®.
Time frame: 6 months
Comparison of HbA1c level at the end of each period of the study (without / with IRTA©)
Blood sample at inclusion, 3 months and 6 months
Time frame: 6 months
Time spent in glucose level higher than 250 mg/dl
Time frame: 6 months
Time spent in glucose level higher than 180 mg/dl
Time frame: 6 months
Time spent in glucose level lower than 70 mg/dl
Time frame: 6 months
Time spent in glucose level lower than 54 mg/dl
Time frame: 6 months
Number of incidents (severe hypoglycemia, diabetic ketoacidosis, hospitalizations related to poor glycemic control)
Time frame: 6 months
Percentage of time spent with or without CGM
Time frame: 6 months
Glycemic variability
Time frame: 6 months
Patients' satisfaction related to CGM and the impact of IRTA© on this satisfaction
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CGM Satisfaction (CGM-SAT) 44-item questionnaire. Higher scores reflect more favorable impact of, and satisfaction with, CGM use.
Time frame: 6 months
Patients' satisfaction related to IRTA©
Satisfaction questionnaire: 5-point Likert scale (1 = strongly agree; 5 = strongly disagree) with each of 18 items.
Time frame: 6 months
Number of connections to the IRTA system
Time frame: 6 months
Number of advice given by the IRTA system
Time frame: 6 months
Type of advice given by the IRTA system that is more often asked
Time frame: 6 months