Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Real time continuous glucose monitoring
Decision support software
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A decision support software
Primary purpose: OTHER

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.

Eligibility criteria: 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®)

Primary outcomes:
measure: 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©)
timeFrame: 6 months
Secondary outcomes:
measure: Comparison of HbA1c level at the end of each period of the study (without / with IRTA©)
timeFrame: 6 months
measure: Time spent in glucose level higher than 250 mg/dl
timeFrame: 6 months
measure: Time spent in glucose level higher than 180 mg/dl
timeFrame: 6 months
measure: Time spent in glucose level lower than 70 mg/dl
timeFrame: 6 months
measure: Time spent in glucose level lower than 54 mg/dl
timeFrame: 6 months
measure: Number of incidents (severe hypoglycemia, diabetic ketoacidosis, hospitalizations related to poor glycemic control)
timeFrame: 6 months
measure: Percentage of time spent with or without CGM
timeFrame: 6 months
measure: Glycemic variability
timeFrame: 6 months
measure: Patients' satisfaction related to CGM and the impact of IRTA© on this satisfaction
timeFrame: 6 months
measure: Patients' satisfaction related to IRTA©
timeFrame: 6 months
measure: Number of connections to the IRTA system
timeFrame: 6 months
measure: Number of advice given by the IRTA system
timeFrame: 6 months
measure: Type of advice given by the IRTA system that is more often asked
timeFrame: 6 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References: