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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)

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ClinicalTrials.gov Identifier: NCT01883024
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : September 17, 2013
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Other: A decision support software Other: Insulin Pump Other: Continuous glucose monitoring Not Applicable

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  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official 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.
Study Start Date : June 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883024


Locations
France
Service d'Endocrinologie-Diabétologie - CHU de Rennes - Hôpital Sud
Rennes, France, 35230
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Isabelle Guilhem Rennes University Hospital

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01883024     History of Changes
Other Study ID Numbers: 2013-A00495-40
LOC 1308 ( Other Identifier: Rennes University Hospital )
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: September 2013

Keywords provided by Rennes University Hospital:
Real time continuous glucose monitoring, decision support software, smartphone application.

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs