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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 14, 2013
First Posted Date  ICMJE June 21, 2013
Last Update Posted Date September 17, 2013
Study Start Date  ICMJE June 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2013)
  • 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.
  • Assessment of changes proposed by the experts [ Time Frame: 3 months ]
  • Assessment of frequency of software use [ Time Frame: 3 months ]
  • Assessment of patient satisfaction [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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.
Official Title  ICMJE 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.
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE
  • Other: A decision support software
  • Other: Insulin Pump
  • Other: Continuous glucose monitoring
Study Arms  ICMJE Type 1 diabetes
Interventions:
  • Other: A decision support software
  • Other: Insulin Pump
  • Other: Continuous glucose monitoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2013)
6
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01883024
Other Study ID Numbers  ICMJE 2013-A00495-40
LOC 1308 ( Other Identifier: Rennes University Hospital )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rennes University Hospital
Study Sponsor  ICMJE Rennes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Isabelle Guilhem Rennes University Hospital
PRS Account Rennes University Hospital
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP