Back to resultsInsulin 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)
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
A decision support software
Insulin Pump
Continuous glucose monitoring
Sponsored by
About this trial
This is an interventional other trial for Type 1 Diabetes focused on measuring Real time continuous glucose monitoring, decision support software, smartphone application.
Eligibility 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
Sites / Locations
- Service d'Endocrinologie-Diabétologie - CHU de Rennes - Hôpital Sud
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Type 1 diabetes
Arm Description
Outcomes
Primary Outcome Measures
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)
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
Assessment of similarity between patient decisions and IPRA© advices
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
Assessment of frequency of software use
Assessment of patient satisfaction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01883024
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Real time continuous glucose monitoring, decision support software, smartphone application.
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Type 1 diabetes
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
A decision support software
Intervention Type
Other
Intervention Name(s)
Insulin Pump
Intervention Type
Other
Intervention Name(s)
Continuous glucose monitoring
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Assessment of similarity between patient decisions and IPRA© advices
Description
Assessment of patient satisfaction about using IPRA© and their frequency of use.
Recording of the changes proposed by the expert patients.
Time Frame
3 months
Title
Assessment of changes proposed by the experts
Time Frame
3 months
Title
Assessment of frequency of software use
Time Frame
3 months
Title
Assessment of patient satisfaction
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Guilhem
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Endocrinologie-Diabétologie - CHU de Rennes - Hôpital Sud
City
Rennes
ZIP/Postal Code
35230
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
26902791
Citation
Esvant A, Lefebvre MA, Campillo-Gimenez B, Lannes M, Delamarre D, Guilhem I, Poirier JY. A Mobile Application Guiding Patients With Type 1 Diabetes Using Sensor-Augmented Insulin Pump Therapy. J Diabetes Sci Technol. 2016 Jun 28;10(4):985-6. doi: 10.1177/1932296816633486. Print 2016 Jul. No abstract available.
Results Reference
result
Learn more about this trial
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.
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