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Completed

NCT Number: NCT04641650

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

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

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Key information

Conditions

Kidney Failure Diabetes Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Saint Joseph Saint Luc

Lyon, 69365, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. Time with Glucose < 70mg/dL

    Time frame: At sensor removal (day 14)

    % time with glucose <70 mg/dL

  3. Time with Glucose > 180 mg/dL

    Time frame: At sensor removal (day 14)

    % time with glucose >180 mg/dL

  4. Glucose total coefficient of variation (CV)

    Time frame: At sensor removal (day 14)

    Glucose total CV (%)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Other

Registry information

Official study title

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

Acronym: FSL DIAL

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 24, 2020
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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