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
NCT ID: NCT04211220
Last Updated: 2022-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
64 participants
INTERVENTIONAL
2020-01-09
2022-03-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Insulin Pump-RT Advisor (IPRA©): a Decision Support Software for Diabetic Patients Treated by Insulin Pump and Using Continuous Glucose Monitoring. Experimental Study. Evaluation by an Expert Patient Panel.
NCT01883024
Impact of Functional Insulinotherapy on Blood Glucose Variability Indicators in Patients With Type 1 Diabetes
NCT00973492
The Real-World Control-IQ Glycemic Control and Quality of Life Study in Type 1 Diabetes in France
NCT07211126
Insulin Titration System Based on Deep Learning
NCT05409391
Evaluation of Interests of FIT Therapy on Diabetics Children Insulin-dependent
NCT01443741
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Type 1 diabetes
A decision support software
Insulin pump Continuous glucose monitoring
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
A decision support software
Insulin pump Continuous glucose monitoring
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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®)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rennes University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU de Rennes
Rennes, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
35RC19_8858_IRTA
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.