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
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
1 other identifier
interventional
64
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2019
CompletedFirst Posted
Study publicly available on registry
December 26, 2019
CompletedStudy Start
First participant enrolled
January 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2022
CompletedAugust 22, 2022
August 1, 2021
2.1 years
December 20, 2019
August 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (13)
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 250 mg/dl
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
- +8 more secondary outcomes
Study Arms (1)
Type 1 diabetes
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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®)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Rennes
Rennes, 35033, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2019
First Posted
December 26, 2019
Study Start
January 9, 2020
Primary Completion
March 3, 2022
Study Completion
March 3, 2022
Last Updated
August 22, 2022
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share