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Food Collection From Type 1 Diabetic Patients Practicing Insulin Functional Therapy (GLUCAL2)

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: NCT04587297
Recruitment Status : Active, not recruiting
First Posted : October 14, 2020
Last Update Posted : October 19, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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Brief Summary:
a food collection will be performed in this study with type 1 diabetic patients trained to carbohydrate counting, to collect data on the meals consumed daily and their quantities for a period of 1 month.

Condition or disease
Diabetes Type 1

Study Design
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Food Collection From Type 1 Diabetic Patients Practicing Insulin Functional Therapy : GLUCAL2
Actual Study Start Date : December 8, 2020
Actual Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 1, 2021

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. number of meals [ Time Frame: one month ]
    our primary outcome is to collect the description of 2000 meals from different patients correctly described.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Type 1 diabetic patients
Criteria

Inclusion criteria:

  • type 1 diabetic patients
  • Using carbohydrate counting and functional insulin therapy
  • Patient with Social security or beneficiary
  • Patient able to read and understand the procedure, and able to express consent for the study protocol

Exclusion criteria:

  • Patient abusing substances
  • person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure -- Patient having a psychological conditions making him unable to follow and understand study protocol
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): NCT04587297


Locations
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France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Study Director: Eric RENARD, MD, PhD University Hospital, Montpellier
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04587297    
Other Study ID Numbers: RECHMPL20_0552
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: October 19, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Diabetes
Functional insulin therapy
carbohydrate counting
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