Clinical trial NCT01883024: 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: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Real time continuous glucose monitoring, decision support software, smartphone application.
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: 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)
timeFrame: 3 months
Secondary outcomes:
measure: Assessment of similarity between patient decisions and IPRA© advices
timeFrame: 3 months
measure: Assessment of changes proposed by the experts
timeFrame: 3 months
measure: Assessment of frequency of software use
timeFrame: 3 months
measure: Assessment of patient satisfaction
timeFrame: 3 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: Service d'Endocrinologie-Diabétologie - CHU de Rennes - Hôpital Sud
Study officials:
affiliation: Rennes University Hospital
name: Isabelle Guilhem
role: PRINCIPAL_INVESTIGATOR
References:
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.