Pilot Study : FreeStyle Libre Pro Flash Continuous Glucose Monitoring System in Subjects With Diabetes on HemoDIALsis (FSL DIAL)

April 3, 2024 updated by: Centre Hospitalier Saint Joseph Saint Luc de Lyon

FreeStyle Libre Pro Flash Continuous Glucose Monitoring (CGM) System in Subjects With Diabetes on HemoDIALsis (FSL-DIAL Pilot Study)

Continuous monitoring of glucose with a FreeStyle Libre pro sensor in diabetic and dialysis patients

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lyon, France, 69365
        • Centre Hospitalier Saint Joseph Saint Luc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Subjects with diabetes on hemodialysis

Description

Inclusion Criteria:

  • Diabetes without any change in treatment in the last 3 months
  • Hemodialysis for > 3 months
  • Recent laboratory HbA1c (< 15 days)

Exclusion Criteria:

  • Patient does not show non-opposition
  • Skin allergy to the sensor
  • Sepsis / Acute anaemia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between estimated Hba1c (or Glucose Management Index (GMI)) with FreeStyle Libre Pro sensor and laboratory Hba1c
Time Frame: At sensor removal (day 14)
Comparison between estimated HbA1c with 14 days of CGM data and laboratory HbA1c (routine blood test in hemodialysis) in each subject
At sensor removal (day 14)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in glucose range
Time Frame: At sensor removal (day 14)
Percent (%) time in glucose range of ≥70 to ≤180 mg/dL (≥3.9 to ≤10 mmol/L), obtained using professional continuous glucose monitoring (CGM)
At sensor removal (day 14)
Time with Glucose < 70mg/dL
Time Frame: At sensor removal (day 14)
% time with glucose <70 mg/dL
At sensor removal (day 14)
Time with Glucose > 180 mg/dL
Time Frame: At sensor removal (day 14)
% time with glucose >180 mg/dL
At sensor removal (day 14)
Glucose total coefficient of variation (CV)
Time Frame: At sensor removal (day 14)
Glucose total CV (%)
At sensor removal (day 14)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Investigators

  • Principal Investigator: Lucien Marchand, MD, Study Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2021

Primary Completion (Actual)

November 9, 2022

Study Completion (Actual)

November 9, 2022

Study Registration Dates

First Submitted

November 18, 2020

First Submitted That Met QC Criteria

November 18, 2020

First Posted (Actual)

November 24, 2020

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSL DIAL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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