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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.

R

Rennes University Hospital

Status

Completed

Conditions

Type 1 Diabetes

Treatments

Other: Continuous glucose monitoring
Other: Insulin Pump
Other: A decision support software

Study type

Interventional

Funder types

Other

Identifiers

NCT01883024
2013-A00495-40
LOC 1308 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

Type 1 diabetes
Other group
Treatment:
Other: A decision support software
Other: Continuous glucose monitoring
Other: Insulin Pump

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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