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. (IPRA)

May 22, 2023 updated by: Rennes University Hospital

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35230
        • Service d'Endocrinologie-Diabétologie - CHU de Rennes - Hôpital Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
Assessment of changes proposed by the experts
Time Frame: 3 months
3 months
Assessment of frequency of software use
Time Frame: 3 months
3 months
Assessment of patient satisfaction
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Isabelle Guilhem, Rennes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

June 14, 2013

First Submitted That Met QC Criteria

June 20, 2013

First Posted (Estimate)

June 21, 2013

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-A00495-40
  • LOC 1308 (Other Identifier: Rennes University Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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