Pilot Study : FreeStyle Libre Pro Flash Continuous Glucose Monitoring System in Subjects With Diabetes on HemoDIALsis
Completed
- Conditions
- Kidney FailureDiabetes
- Registration Number
- NCT04641650
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference between estimated Hba1c (or Glucose Management Index (GMI)) with FreeStyle Libre Pro sensor and laboratory Hba1c 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
Name Time Method Time in glucose range 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)
Time with Glucose > 180 mg/dL At sensor removal (day 14) % time with glucose \>180 mg/dL
Glucose total coefficient of variation (CV) At sensor removal (day 14) Glucose total CV (%)
Time with Glucose < 70mg/dL At sensor removal (day 14) % time with glucose \<70 mg/dL
Trial Locations
- Locations (1)
Centre Hospitalier Saint Joseph Saint Luc
🇫🇷Lyon, France