Type 1 Diabetic Post Prandial Glycemia Evaluation Using an Algorithm

Type I Diabetes Clinical Trial

— EGHYA  

Official title:

Type 1 Diabetic Post Prandial Glycemia Evaluation Using an Algorithm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05151770
• Other study ID #: 2021-MDT1-001
• Secondary ID: 2021-AO2599-32
• Status: Completed
• Start date: December 30, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: April 2022
• Source: M-DT1
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 30, 2022
• Est. primary completion date: May 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type I Diabetes

Intervention

Other:
• Measure of glycemia levels and comparison to algorithm predictions
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.

Locations

Country	Name	City	State
France	APHM	Marseille
France	Hopital Sainte Musse	Toulon

Sponsors (3)

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

Country where clinical trial is conducted

France, 

Outcome

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