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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04641650
Recruitment Status : Not yet recruiting
First Posted : November 24, 2020
Last Update Posted : December 14, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Saint Joseph Saint Luc de Lyon

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

Condition or disease
Kidney Failure Diabetes

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: FreeStyle Libre Pro Flash Continuous Glucose Monitoring (CGM) System in Subjects With Diabetes on HemoDIALsis (FSL-DIAL Pilot Study)
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : June 1, 2021



Primary Outcome Measures :
  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 Outcome Measures :
  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 (%)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects with diabetes on hemodialysis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04641650


Contacts
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Contact: Fanny Doroszewski 00330478618398 fdoroszewski@chsjsl.fr

Sponsors and Collaborators
Centre Hospitalier Saint Joseph Saint Luc de Lyon
Investigators
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Principal Investigator: Lucien Marchand, MD Study Principal Investigator
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Responsible Party: Centre Hospitalier Saint Joseph Saint Luc de Lyon
ClinicalTrials.gov Identifier: NCT04641650    
Other Study ID Numbers: FSL DIAL
First Posted: November 24, 2020    Key Record Dates
Last Update Posted: December 14, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Saint Joseph Saint Luc de Lyon:
glycemia
diabetes
kidney failure
dialysis
glucose sensor
Additional relevant MeSH terms:
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Renal Insufficiency
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases