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Study of Acceptability of a New Distance-learning Tool "MyFIT" (MyFIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04512885
Recruitment Status : Completed
First Posted : August 14, 2020
Last Update Posted : July 25, 2022
Sponsor:
Information provided by (Responsible Party):
EVA FEIGERLOVA, Central Hospital, Nancy, France

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

The investigators developed an on-line learning tool "MyFIT" enabling to patients with T1D to acquire the knowledge and skills for practicing functional insulin therapy from their home.

The aim of the present study is to evaluate the acceptability of this new learning modality via the tool "MyFIT" by the patients and by the health professionnals.


Condition or disease Intervention/treatment
Type1diabetes Other: Survey

Study Design
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Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Study of the Acceptability of a New Distance-learning Tool for Functional Insulin Therapy "MyFIT" by Patients With Type 1 Diabetes (T1D) and by Healthcare Professionals
Actual Study Start Date : July 16, 2020
Actual Primary Completion Date : September 26, 2020
Actual Study Completion Date : September 26, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with type 1 diabetes Other: Survey
Survey via questionnaire
Health professionals Other: Survey
Survey via questionnaire


Outcome Measures
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Primary Outcome Measures :
  1. success rate [ Time Frame: 2 months ]
    score of the formation (80% correct answers)


Secondary Outcome Measures :
  1. satisfaction measured by auto-questionnaire [ Time Frame: 2 months ]
    calculation of total score of the answers on 6-point likert scale (minimum value = 0; maximum value = 100% , higher scores mean a better outcome)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with Type 1 diabetes followed in the department of Endocrinology, diabetology and nutrition (CHRU de Nancy)
Criteria

Inclusion Criteria:

  • type one diabetes on intensified insulin therapy

Exclusion Criteria:

  • Hearing loss
  • Visual problems
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04512885


Locations
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France
CHRU Nancy
Nancy, France, 54000
Sponsors and Collaborators
Central Hospital, Nancy, France
More Information
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Responsible Party: EVA FEIGERLOVA, Assistant Professor of Endocrinology, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT04512885    
Other Study ID Numbers: 2020PI162-49
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: July 25, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases