NCT04641650

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2021

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

November 18, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 24, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

July 21, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2022

Completed
Last Updated

April 4, 2024

Status Verified

April 1, 2024

Enrollment Period

1.3 years

First QC Date

November 18, 2020

Last Update Submit

April 3, 2024

Conditions

Kidney FailureDiabetes

Keywords

glycemiadiabeteskidney failuredialysisglucose sensor

Outcome Measures

Primary Outcomes (1)

  • Difference between estimated Hba1c (or Glucose Management Index (GMI)) with FreeStyle Libre Pro sensor and laboratory Hba1c

    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 Outcomes (4)

  • Time in glucose range

    At sensor removal (day 14)

  • Time with Glucose < 70mg/dL

    At sensor removal (day 14)

  • Time with Glucose > 180 mg/dL

    At sensor removal (day 14)

  • Glucose total coefficient of variation (CV)

    At sensor removal (day 14)

Eligibility Criteria

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

Subjects with diabetes on hemodialysis

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Saint Joseph Saint Luc

Lyon, 69365, France

Location

MeSH Terms

Conditions

Renal InsufficiencyDiabetes Mellitus

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Lucien Marchand, MD

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 18, 2020

First Posted

November 24, 2020

Study Start

July 21, 2021

Primary Completion

November 9, 2022

Study Completion

November 9, 2022

Last Updated

April 4, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)