Type 1 Diabetic Post Prandial Glycemia Evaluation Using an Algorithm
EGHYA
2 other identifiers
observational
40
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2021
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2021
CompletedFirst Posted
Study publicly available on registry
December 9, 2021
CompletedStudy Start
First participant enrolled
December 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedMarch 15, 2023
April 1, 2022
4 months
November 12, 2021
March 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Algorithm efficacy
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 Outcomes (5)
Algorithm efficacy (lower margin of error)
15 days
Algorithm efficacy versus meal composition
15 days
Influence of the age of the patients on algorithm results
15 days
Influence of the BMI on algorithms results
15 days
Influence of the insulin administration on algorithm results
15 days
Interventions
The study aims to evaluate the efficacy of a new algorithm in predicting the evolution of glycemia levels after a full meal. Glycemia levels measured during and after a full meal will be compared to the values predicted by the algorithm. Composition of the meals will also be collected.
Eligibility Criteria
Type I diabetes
You may qualify if:
- Type 1 diabetes
- ≥ 18 years old
- Hb1Ac\<12%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M-DT1lead
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mercollaborator
- Assistance Publique Hopitaux De Marseillecollaborator
Study Sites (2)
APHM
Marseille, France
Hopital Sainte Musse
Toulon, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2021
First Posted
December 9, 2021
Study Start
December 30, 2021
Primary Completion
May 2, 2022
Study Completion
December 30, 2022
Last Updated
March 15, 2023
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share