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NCT Number: NCT01883024

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.

The purpose of the study is to assess the relevance of the advices provided by the IPRA© smartphone application for guiding the responses of insulin pump treated type 1 diabetes patients using real-time continuous glucose monitoring.

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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

Service d'Endocrinologie-Diabétologie - CHU de Rennes - Hôpital Sud

Rennes, 35230, France

About this study

Patients will be asked to evaluate the IPRA advices by connecting to IPRA© application by using their smartphone, 30 times a week for two weeks. At the end of this two week period, a satisfaction questionnaire will be completed.

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 for more than 2 years,
  • patients treated by insulin pump for more than 6 months,
  • patients using of real-time continuous glucose monitoring for more than 3 months,
  • patients able to evaluate the IPRA advices by connecting to IPRA© application 30 times a week,
  • patient able to provide written informed consent,
  • patient able to provide written non-disclosure agreement

Exclusion criteria

  • pregnancy or breastfeeding,
  • current infectious disease,
  • patients with no smartphone® or Internet access,
  • adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty

Treatment and study plan

A decision support software

Other

Insulin Pump

Other

Continuous glucose monitoring

Other

Primary outcomes

  1. Patient agreement with the IPRA© advices: global rate of agreement, according to advice subtypes, according to blood glucose levels, according to the situations (pre or post-meal, bedtime)

    Time frame: 3 months

    Assessment of the relevance of the advices provided by the IPRA© smartphone application for guiding the responses of insulin pump treated type 1 diabetes patients using real-time continuous glucose monitoring.

Secondary outcomes

  1. Assessment of similarity between patient decisions and IPRA© advices

    Time frame: 3 months

    Assessment of patient satisfaction about using IPRA© and their frequency of use.

    Recording of the changes proposed by the expert patients.

  2. Assessment of changes proposed by the experts

    Time frame: 3 months

  3. Assessment of frequency of software use

    Time frame: 3 months

  4. Assessment of patient satisfaction

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

Prospective Study, 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.

Acronym: IPRA

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 21, 2013
Registry last updated
May 24, 2023

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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