Type 1 Diabetic Post Prandial Glycemia Evaluation Using an Algorithm

Completed

• Conditions: Type I Diabetes

• Registration Number: NCT05151770
• Lead Sponsor: M-DT1

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-12
• Study First Submitted QC: 2021-11-25
• Study First Posted: 2021-12-09
• Study Start: 2021-12-30
• Status Verified: 2022-04
• Primary Completion: 2022-05-02
• Study Completion: 2022-12-30
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

APHM; 🇫🇷 Marseille, France

Hopital Sainte Musse; 🇫🇷 Toulon, France