NCT05098301

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 28, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

November 30, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

October 24, 2022

Status Verified

October 1, 2022

Enrollment Period

4 months

First QC Date

October 18, 2021

Last Update Submit

October 21, 2022

Conditions

Diabetes

Keywords

DiabetesFunctional insulin therapy

Outcome Measures

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

    day 1

Secondary Outcomes (1)

  • measure time-in-range evolution adjustment of insulin therapy parameters

    day 1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Type 1 diabetic patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Eric RENARD, MD, PhD

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2021

First Posted

October 28, 2021

Study Start

November 30, 2021

Primary Completion

April 1, 2022

Study Completion

July 1, 2022

Last Updated

October 24, 2022

Record last verified: 2022-10

Locations

FR(1)