NCT04587297

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

December 8, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

October 7, 2020

Last Update Submit

April 13, 2022

Conditions

Diabetes Type 1

Keywords

DiabetesFunctional insulin therapycarbohydrate counting

Outcome Measures

Primary Outcomes (1)

  • number of meals

    our primary outcome is to collect the description of 2000 meals from different patients correctly described.

    one month

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Type 1 diabetic patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Eric RENARD, MD, PhD

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 7, 2020

First Posted

October 14, 2020

Study Start

December 8, 2020

Primary Completion

June 1, 2021

Study Completion

December 1, 2021

Last Updated

April 14, 2022

Record last verified: 2022-04

Locations

FR(1)