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 (IRTA)
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
A decision support software
Sponsored by
About this trial
This is an interventional other trial for Type 1 Diabetes focused on measuring Real time continuous glucose monitoring, Decision support software
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®)
Sites / Locations
- CHU de Rennes
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Type 1 diabetes
Arm Description
Outcomes
Primary Outcome Measures
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®.
Secondary Outcome Measures
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
Time spent in glucose level higher than 250 mg/dl
Time spent in glucose level higher than 180 mg/dl
Time spent in glucose level lower than 70 mg/dl
Time spent in glucose level lower than 54 mg/dl
Number of incidents (severe hypoglycemia, diabetic ketoacidosis, hospitalizations related to poor glycemic control)
Percentage of time spent with or without CGM
Glycemic variability
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.
Patients' satisfaction related to IRTA©
Satisfaction questionnaire: 5-point Likert scale (1 = strongly agree; 5 = strongly disagree) with each of 18 items.
Number of connections to the IRTA system
Number of advice given by the IRTA system
Type of advice given by the IRTA system that is more often asked
Full Information
NCT ID
NCT04211220
First Posted
December 20, 2019
Last Updated
August 19, 2022
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04211220
Brief Title
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
Acronym
IRTA
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 9, 2020 (Actual)
Primary Completion Date
March 3, 2022 (Actual)
Study Completion Date
March 3, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Real time continuous glucose monitoring, Decision support software
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A decision support software
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Type 1 diabetes
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
A decision support software
Intervention Description
Insulin pump Continuous glucose monitoring
Primary Outcome Measure Information:
Title
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©)
Description
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®.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Comparison of HbA1c level at the end of each period of the study (without / with IRTA©)
Description
Blood sample at inclusion, 3 months and 6 months
Time Frame
6 months
Title
Time spent in glucose level higher than 250 mg/dl
Time Frame
6 months
Title
Time spent in glucose level higher than 180 mg/dl
Time Frame
6 months
Title
Time spent in glucose level lower than 70 mg/dl
Time Frame
6 months
Title
Time spent in glucose level lower than 54 mg/dl
Time Frame
6 months
Title
Number of incidents (severe hypoglycemia, diabetic ketoacidosis, hospitalizations related to poor glycemic control)
Time Frame
6 months
Title
Percentage of time spent with or without CGM
Time Frame
6 months
Title
Glycemic variability
Time Frame
6 months
Title
Patients' satisfaction related to CGM and the impact of IRTA© on this satisfaction
Description
CGM Satisfaction (CGM-SAT) 44-item questionnaire. Higher scores reflect more favorable impact of, and satisfaction with, CGM use.
Time Frame
6 months
Title
Patients' satisfaction related to IRTA©
Description
Satisfaction questionnaire: 5-point Likert scale (1 = strongly agree; 5 = strongly disagree) with each of 18 items.
Time Frame
6 months
Title
Number of connections to the IRTA system
Time Frame
6 months
Title
Number of advice given by the IRTA system
Time Frame
6 months
Title
Type of advice given by the IRTA system that is more often asked
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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®)
Facility Information:
Facility Name
CHU de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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