NCT01530789

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2011

Typical duration for all trials

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

August 6, 2015

Status Verified

October 1, 2012

Enrollment Period

2.9 years

First QC Date

February 8, 2012

Last Update Submit

August 5, 2015

Conditions

Type 1 Diabetic

Keywords

TelemedecineTelemedecine nurseDelegation of tasksType 1 diabetes

Outcome Measures

Primary Outcomes (1)

  • Percentage of patient using the system

    The using of the system is estimated by the frequency of dose proposition by electronic pad

    6 month

Secondary Outcomes (3)

  • satisfaction level of the patient and quality of life

    6 month

  • satisfaction level of physician

    6 month

  • satisfaction level of the telemedecin nurse

    6 month

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diabetic type 1 patients with the electronic pad

You may qualify if:

  • 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

You may not qualify if:

  • patient diabetic type 2
  • patient without the electronic pad in a smartphone
  • children below 12 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2012

First Posted

February 10, 2012

Study Start

May 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

August 6, 2015

Record last verified: 2012-10