Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 :
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 1 diabetes | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A decision support software | Other | Insulin pump Continuous glucose monitoring |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Rennes | Rennes | 35033 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A decision support software
Not provided
Not provided
Not provided
Not provided
| 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 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided