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

Type 1 Diabetes Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04211220
• Other study ID #: 35RC19_8858_IRTA
• Status: Completed
• Phase: N/A
• Start date: January 9, 2020
• Est. completion date: March 3, 2022

Study information

• Verified date: August 2021
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 3, 2022
• Est. primary completion date: March 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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®)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• A decision support software
Insulin pump Continuous glucose monitoring

Locations

Country	Name	City	State
France	CHU de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Time spent in glucose level higher than 250 mg/dl		6 months
Secondary	Time spent in glucose level higher than 180 mg/dl		6 months
Secondary	Time spent in glucose level lower than 70 mg/dl		6 months
Secondary	Time spent in glucose level lower than 54 mg/dl		6 months
Secondary	Number of incidents (severe hypoglycemia, diabetic ketoacidosis, hospitalizations related to poor glycemic control)		6 months
Secondary	Percentage of time spent with or without CGM		6 months
Secondary	Glycemic variability		6 months
Secondary	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
Secondary	Patients' satisfaction related to IRTA©	Satisfaction questionnaire: 5-point Likert scale (1 = strongly agree; 5 = strongly disagree) with each of 18 items.	6 months
Secondary	Number of connections to the IRTA system		6 months
Secondary	Number of advice given by the IRTA system		6 months
Secondary	Type of advice given by the IRTA system that is more often asked		6 months