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Paramedical Consultation in Telemedicine

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
ClinicalTrials.gov Identifier:
NCT01530789
First received: February 8, 2012
Last updated: April 19, 2013
Last verified: October 2012
History of Changes
  Purpose

Feasibility monocentrique opened study estimating the use of an electronic personalized educational plan (ePEP) for the follow-up by nurses of 50 patients diabetics type 1 during 6 months having an electronic pad.


Condition
Type 1 Diabetic

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Paramedical Consultation in Type 1 Diabetic Patients in Telemedicine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète:

Primary Outcome Measures:
  • Percentage of patient using the system [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    The using of the system is estimated by the frequency of dose proposition by electronic pad


Secondary Outcome Measures:
  • satisfaction level of the patient and quality of life [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • satisfaction level of physician [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    The satisfaction level of physician about the follow-up by e-PEP

  • satisfaction level of the telemedecin nurse [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Evaluation of the satisfaction level of the telemedecin nurse about the follow-up by e-PEP


Estimated Enrollment: 50
Study Start Date: May 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Diabetic type 1 patients with the electronic pad

Criteria

Inclusion Criteria:

  • patient diabetic type 1
  • patient with the electronic pad in a smartphone
  • adults
  • children between 12 and 17 years 11 months
  • patient having signed the consent

Exclusion Criteria:

  • patient diabetic type 2
  • patient without the electronic pad in a smartphone
  • children below 12 years old
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
ClinicalTrials.gov Identifier: NCT01530789     History of Changes
Other Study ID Numbers: 2011-A00311-40
Study First Received: February 8, 2012
Last Updated: April 19, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète:
Telemedecine
Telemedecine nurse
Delegation of tasks
Type 1 diabetes

ClinicalTrials.gov processed this record on May 19, 2013