Data Therapy Collection to Evaluate Performances of an Automated Insulin Titration Algorithm Compared to Standard Method of Titration

Diabetes Clinical Trial

— GLUCAL3  

Official title:

Data Therapy Collection to Evaluate Performances of an Automated Insulin Titration Algorithm Compared to Standard Method of Titration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05098301
• Other study ID #: RECHMPL21_0562
• Status: Completed
• Start date: November 30, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: October 2022
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A data collection of blood glucose values, insulin, meal composition will be performed for a period of two months, to evaluate the performances of an automated insulin titration algorithm

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria:

• Person with Type 1 diabetes

• Treated by basal-bolus therapy with MDI or pump

• Patient with social security or beneficiary of medical coverage

• Patient using functional insulin therapy or starting and education course

• Patient able to read and understand the procedure, and able to express consent for study protocol

Exclusion criteria:

• Patient abusing substances

• Patient deprived of liberty by judicial or administrative decision, person subject to a legal protection measure, patient having a psychological condition making him unable to follow and understand study protocol

Related Conditions & MeSH terms

• Diabetes

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluate the performances of an insulin titration algorithm	to evaluate the performances of an insulin titration algorithm to calculate insulin therapy parameters at the same precision of an expert practitioner	day 1
Secondary	measure time-in-range evolution adjustment of insulin therapy parameters	to measure time-in-range evolution before and after adjustment of insulin therapy parameters by practitioner	day 1