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.

Type 1 Diabetes Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01883024
• Other study ID #: 2013-A00495-40
• Secondary ID: LOC 1308
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: September 2013

Study information

• Verified date: May 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• A decision support software

• Insulin Pump

• Continuous glucose monitoring

Locations

Country	Name	City	State
France	Service d'Endocrinologie-Diabétologie - CHU de Rennes - Hôpital Sud	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (1)

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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	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.	3 months
Secondary	Assessment of changes proposed by the experts		3 months
Secondary	Assessment of frequency of software use		3 months
Secondary	Assessment of patient satisfaction		3 months