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

Rennes University Hospital

Status

Completed

Conditions

Type 1 Diabetes

Treatments

Other: A decision support software

Study type

Interventional

Funder types

Other

Identifiers

NCT04211220

35RC19_8858_IRTA

Details and patient eligibility

About

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

Full 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.

Enrollment

64 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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®)