EGHYA: Type 1 Diabetic Post Prandial Glycemia Evaluation Using an Algorithm

Sponsor

M-DT1 (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05151770

Collaborator

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer (Other), Assistance Publique Hopitaux De Marseille (Other)

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Type I Diabetes	Other: Measure of glycemia levels and comparison to algorithm predictions

Study Design

Study Type:

Observational

Actual Enrollment :

40 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

Type 1 Diabetic Post Prandial Glycemia Evaluation Using an Algorithm

Actual Study Start Date :

Dec 30, 2021

Actual Primary Completion Date :

May 2, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Outcome Measures

Primary Outcome Measures

Algorithm efficacy [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.

Secondary Outcome Measures

Algorithm efficacy (lower margin of error) [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).
Algorithm efficacy versus meal composition [15 days]
Meals will be analyzed within different groups according to their respective nutritional index. For each group, algorithm prediction reliability will be determined.
Influence of the age of the patients on algorithm results [15 days]
The Algorithm efficacy will be analyzed according to the age of patients
Influence of the BMI on algorithms results [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
Influence of the insulin administration on algorithm results [15 days]
Data obtained from patients using insulin pumps will be compared to data obtained from patients using multiple daily insulin injections.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	APHM	Marseille		France
2	Hopital Sainte Musse	Toulon		France

Sponsors and Collaborators

M-DT1
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Assistance Publique Hopitaux De Marseille

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

M-DT1

ClinicalTrials.gov Identifier:

NCT05151770

Other Study ID Numbers:

2021-MDT1-001
2021-AO2599-32

First Posted:

Dec 9, 2021

Last Update Posted:

Aug 24, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by M-DT1

Type I diabetes

Hyperglycemia

Post prandial glycemia

algorithm

Additional relevant MeSH terms:

Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Aug 24, 2022