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.

NCT ID: NCT01883024

Last Updated: 2023-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-09-30

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.

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Type 1 diabetes

Group Type OTHER

A decision support software

Intervention Type OTHER

Insulin Pump

Intervention Type OTHER

Continuous glucose monitoring

Intervention Type OTHER

Interventions

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A decision support software

Intervention Type OTHER

Insulin Pump

Intervention Type OTHER

Continuous glucose monitoring

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isabelle Guilhem

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

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Service d'Endocrinologie-Diabétologie - CHU de Rennes - Hôpital Sud

Rennes, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 26902791 (View on PubMed)

Other Identifiers

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LOC 1308

Identifier Type: OTHER

Identifier Source: secondary_id

2013-A00495-40

Identifier Type: -

Identifier Source: org_study_id

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