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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- 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©)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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®)
Arms & Interventions
Type 1 diabetes
Intervention: A decision support software (Other)
Outcomes
Primary Outcomes
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©)
Time Frame: 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 Outcomes
- Glycemic variability(6 months)
- Number of incidents (severe hypoglycemia, diabetic ketoacidosis, hospitalizations related to poor glycemic control)(6 months)
- 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)
- 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)
- Time spent in glucose level higher than 180 mg/dl(6 months)
- Time spent in glucose level lower than 70 mg/dl(6 months)
- Percentage of time spent with or without CGM(6 months)
- Patients' satisfaction related to IRTA©(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)