Type 1 Diabetic Post Prandial Glycemia Evaluation Using an Algorithm (EGHYA)

March 14, 2023 updated by: M-DT1
The aim of this study is to demonstrate the efficacy of an algorithm to anticipate the post prandial glycemic profile in type I diabetic patient.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

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

  • France
      • Marseille, France
        • APHM
      • Toulon, France
        • Hôpital Sainte Musse

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

Type I diabetes

Description

Inclusion Criteria:

  • Type 1 diabetes
  • ≥ 18 years old
  • Hb1Ac<12%

Exclusion Criteria:

  • Patient without continuous glucose monitoring system
  • Disease other than diabetes (bulimia, anorexia…)
  • Dialysis patient
  • Known history of drug or alcohol abuse
  • Patient under judicial protection
  • Person deprived of liberty
  • Pregnant, parturient or breastfeeding woman
  • Patient in psychiatric care
  • Patient admitted to a health or social institution for purposes other than research
  • Any reasons that might interfere with the evaluation of the study objectives

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Algorithm efficacy
Time Frame: 15 days
The Algorithm efficacy in predicting the risk or absence of risk of hyperglycemia two hours after taking a full meal is evaluated by comparing glycemic values calculated by the algorithm and those obtained using continuous glucose monitoring system measurements.
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Algorithm efficacy (lower margin of error)
Time Frame: 15 days
The Algorithm efficacy in predicting the risk or absence of risk of hyperglycemia two hours after taking a full meal is evaluated by comparing glycemic values calculated by the algorithm and those obtained using continuous glucose monitoring system measurements (the accepted margin of error is reduced by 25 to 50% when compared with primary outcome).
15 days
Algorithm efficacy versus meal composition
Time Frame: 15 days
Meals will be analyzed within different groups according to their respective nutritional index. For each group, algorithm prediction reliability will be determined.
15 days
Influence of the age of the patients on algorithm results
Time Frame: 15 days
The Algorithm efficacy will be analyzed according to the age of patients
15 days
Influence of the BMI on algorithms results
Time Frame: 15 days
Weight and height of patients will be combined to report BMI in kg/m2. Algorithm efficacy will be analyzed according to the BMI of patients
15 days
Influence of the insulin administration on algorithm results
Time Frame: 15 days
Data obtained from patients using insulin pumps will be compared to data obtained from patients using multiple daily insulin injections.
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M-DT1

Collaborators

Assistance Publique Hopitaux De Marseille
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

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)

December 30, 2021

Primary Completion (Actual)

May 2, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

November 12, 2021

First Submitted That Met QC Criteria

November 25, 2021

First Posted (Actual)

December 9, 2021

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-MDT1-001
  • 2021-AO2599-32 (Other Identifier: Centre intercommunal Toulon La seine sur Mer)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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