Data Therapy Collection to Evaluate Performances of an Automated Insulin Titration Algorithm Compared to Standard Method of Titration (GLUCAL3)

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

Study Overview

• Status: Completed
• Conditions: Diabetes

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Type 1 diabetic patients

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Eric RENARD, MD, PhD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: October 18, 2021
• First Submitted That Met QC Criteria: October 18, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Actual): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Diabetes; Functional insulin therapy
• Other Study ID Numbers: RECHMPL21_0562

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No