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
- Conditions
- Type 1 Diabetes
- Interventions
- Other: A decision support software
- Registration Number
- NCT04211220
- Lead Sponsor
- Rennes University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- 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
- 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®)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Type 1 diabetes A decision support software -
- Primary Outcome Measures
Name Time Method 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©) 6 months 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®.
- Secondary Outcome Measures
Name Time Method Time spent in glucose level higher than 250 mg/dl 6 months Patients' satisfaction related to CGM and the impact of IRTA© on this satisfaction 6 months CGM Satisfaction (CGM-SAT) 44-item questionnaire. Higher scores reflect more favorable impact of, and satisfaction with, CGM use.
Number of connections to the IRTA system 6 months Time spent in glucose level lower than 54 mg/dl 6 months Comparison of HbA1c level at the end of each period of the study (without / with IRTA©) 6 months Blood sample at inclusion, 3 months and 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 Glycemic variability 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 Patients' satisfaction related to IRTA© 6 months Satisfaction questionnaire: 5-point Likert scale (1 = strongly agree; 5 = strongly disagree) with each of 18 items.
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
Trial Locations
- Locations (1)
CHU de Rennes
🇫🇷Rennes, France