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Completed

NCT Number: NCT04211220

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

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

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Rennes

Rennes, 35033, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®)

Treatment and study plan

A decision support software

Other

Insulin pump Continuous glucose monitoring

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©)

    Time frame: 6 months

    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®.

Secondary outcomes

  1. Comparison of HbA1c level at the end of each period of the study (without / with IRTA©)

    Time frame: 6 months

    Blood sample at inclusion, 3 months and 6 months

  2. Time spent in glucose level higher than 250 mg/dl

    Time frame: 6 months

  3. Time spent in glucose level higher than 180 mg/dl

    Time frame: 6 months

  4. Time spent in glucose level lower than 70 mg/dl

    Time frame: 6 months

  5. Time spent in glucose level lower than 54 mg/dl

    Time frame: 6 months

  6. Number of incidents (severe hypoglycemia, diabetic ketoacidosis, hospitalizations related to poor glycemic control)

    Time frame: 6 months

  7. Percentage of time spent with or without CGM

    Time frame: 6 months

  8. Glycemic variability

    Time frame: 6 months

  9. Patients' satisfaction related to CGM and the impact of IRTA© on this satisfaction

    Time frame: 6 months

    CGM Satisfaction (CGM-SAT) 44-item questionnaire. Higher scores reflect more favorable impact of, and satisfaction with, CGM use.

  10. Patients' satisfaction related to IRTA©

    Time frame: 6 months

    Satisfaction questionnaire: 5-point Likert scale (1 = strongly agree; 5 = strongly disagree) with each of 18 items.

  11. Number of connections to the IRTA system

    Time frame: 6 months

  12. Number of advice given by the IRTA system

    Time frame: 6 months

  13. Type of advice given by the IRTA system that is more often asked

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study 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

Acronym: IRTA

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 26, 2019
Registry last updated
Aug 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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