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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Other: A decision support software


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women ≥ 18 years of age Patients with type 1 diabetes mellitus for more than 2 years Treated by either insulin pump for more than 6 months or multiple daily insulin injections. Using Freestyle Libre® for more than 3 months Accepting IRTA use Patient able to provide free and informed consent Patient able to provide written non-disclosure agreement Exclusion Criteria: Pregnancy, breastfeeding or pregnancy project in the future 6 months Patients with no smart phone or internet access Patients legally protected (under judicial protection, guardianship or supervision) Patients with acute illness (psychiatric, infection, cancer,…) Patients using another CGM system (Enlite® or Dexcom G4®)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: A decision support software
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Type 1 diabetes<br> | Other: A decision support software<br>* Insulin pump Continuous glucose monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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®. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 
| Time spent in glucose level higher than 250 mg/dl |  | 6 months | 
| Time spent in glucose level higher than 180 mg/dl |  | 6 months | 
| Time spent in glucose level lower than 70 mg/dl |  | 6 months | 
| Time spent in glucose level lower than 54 mg/dl |  | 6 months | 
| Number of incidents (severe hypoglycemia, diabetic ketoacidosis, hospitalizations related to poor glycemic control) |  | 6 months | 
| Percentage of time spent with or without CGM |  | 6 months | 
| Glycemic variability |  | 6 months | 
| Patients' satisfaction related to CGM and the impact of IRTA© on this satisfaction | CGM Satisfaction (CGM-SAT) 44-item questionnaire. Higher scores reflect more favorable impact of, and satisfaction with, CGM use. | 6 months | 
| Patients' satisfaction related to IRTA© | Satisfaction questionnaire: 5-point Likert scale (1 = strongly agree; 5 = strongly disagree) with each of 18 items. | 6 months | 
| Number of connections to the IRTA system |  | 6 months | 
| Number of advice given by the IRTA system |  | 6 months | 
| Type of advice given by the IRTA system that is more often asked |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Real time continuous glucose monitoring, Decision support software