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

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

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Other: A decision support software

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35033
    • CHU de Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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®)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Type 1 diabetes	Other: A decision support software; Insulin pump Continuous glucose monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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		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

Collaborators and Investigators

• Sponsor: Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2020
• Primary Completion (Actual): March 3, 2022
• Study Completion (Actual): March 3, 2022

Study Registration Dates

• First Submitted: December 20, 2019
• First Submitted That Met QC Criteria: December 24, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Real time continuous glucose monitoring; Decision support software
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 35RC19_8858_IRTA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No