- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04512885
Study of Acceptability of a New Distance-learning Tool "MyFIT" (MyFIT)
July 22, 2022 updated by: EVA FEIGERLOVA, Central Hospital, Nancy, France
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
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
35
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nancy, France, 54000
- CHRU Nancy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adult patients with Type 1 diabetes followed in the department of Endocrinology, diabetology and nutrition (CHRU de Nancy)
Description
Inclusion Criteria:
- type one diabetes on intensified insulin therapy
Exclusion Criteria:
- Hearing loss
- Visual problems
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with type 1 diabetes
|
Survey via questionnaire
|
Health professionals
|
Survey via questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
success rate
Time Frame: 2 months
|
score of the formation (80% correct answers)
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 16, 2020
Primary Completion (Actual)
September 26, 2020
Study Completion (Actual)
September 26, 2020
Study Registration Dates
First Submitted
August 11, 2020
First Submitted That Met QC Criteria
August 11, 2020
First Posted (Actual)
August 14, 2020
Study Record Updates
Last Update Posted (Actual)
July 25, 2022
Last Update Submitted That Met QC Criteria
July 22, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020PI162-49
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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