Food Collection From Type 1 Diabetic Patients Practicing... | NCT04587297

Studies
Food Collection From Type 1 Diabetic Patients Practicing Insulin Functional Therapy

NCT04587297

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Apr 14, 2022Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Diabetes Type 1

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 8, 2020Actual

Primary Completion Date

Jun 1, 2021Actual

Completion Date

Dec 1, 2021Actual

First Submitted Date

Oct 7, 2020

First Submission Date that Met QC Criteria

Oct 7, 2020

First Posted Date

Oct 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2022

Last Update Posted Date

Apr 14, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of meals	our primary outcome is to collect the description of 2000 meals from different patients correctly described.	one month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Type 1 diabetic patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric RENARD, MD, PhD	University Hospital, Montpellier	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided