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 Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Other: A decision support software
* Other: Insulin Pump
* Other: Continuous glucose monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Type 1 diabetes<br> | Other: A decision support software<br> <br> Other: Insulin Pump<br> <br> Other: Continuous glucose monitoring<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Assessment of changes proposed by the experts |  | 3 months | 
| Assessment of frequency of software use |  | 3 months | 
| Assessment of patient satisfaction |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Real time continuous glucose monitoring, decision support software, smartphone application.