Diabetes, Kidney Failure
Conditions
Keywords
glycemia, diabetes, kidney failure, dialysis, glucose sensor
Brief summary
Continuous monitoring of glucose with a FreeStyle Libre pro sensor in diabetic and dialysis patients
Interventions
None listed
Sponsors
Centre Hospitalier Saint Joseph Saint Luc de Lyon
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 < 70mg/dL | At sensor removal (day 14) | % time with glucose \<70 mg/dL |
| 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 (%) |
Countries
France
Outcome results
None listed