CClinicalTrials.gg
CompletedNCT05098301GLUCAL3Updated Oct 24, 2022

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

An observational study in Diabetes, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-10-24.

Sponsored by University Hospital, Montpellier · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 75 Years
Sex
All
01

Study 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

02

Conditions studied

  • Diabetes

Keywords

  • Diabetes
  • Functional insulin therapy
03

In context

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Type 1 diabetic patients

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: day 1

Secondary outcomes

  1. 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

    Time frame: day 1

07

Study locations

1 site
  • Uhmontpellier
    Montpellier, 34295, France
08

References and documents

Individual participant data

Plan to share: Undecided — NC

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05098301
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Oct 28, 2021
Start date
Nov 30, 2021
Primary completion
Apr 1, 2022
Completion
Jul 1, 2022
Last update
Oct 24, 2022

Study contacts

Eric RENARD, MD, PhD
study director · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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