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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014