End-Stage Kidney Disease, Type 2 Diabetes Mellitus
Conditions
Keywords
Hemodialysis, Continuous glucose monitoring, Hypoglycemia, Hyperglycemia
Brief summary
The purpose of this study is to investigate differences in glycemia * during the whole hemodialysis day and the whole freeday * during hemodialysis, during the evening and the night after hemodialysis and at the same time intervals during the freeday in an unselected type 2 diabetic patient group using both glucose-containing and glucose-free dialysate.
Interventions
OTHERGlucose-containing compared to glucose-free hemodialysate
Comparison of effects on glucose variation
Sponsors
Tampere University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* type 2 diabetic patient * undergoing stable intermittent thrice weekly hemodialysis for at least one month
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose below 4.0 mmol/l | In the end of a two week period | In the end of a two-week glucose-containing and glucose-free period percentage of hypoglycemic values of continuous glucose monitoring during the whole hemodialysis day is compared to the whole freeday. Similar comparison is made between the whole glucose-containing and the whole glucose-free hemodialysis day as well as between the whole glucose-containing and the whole glucose-free freeday. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose below 4.0 mmol/l during specified time intervals | In the end of a two-week period | Percentage of hypoglycemia during the specified time intervals is compared within the glucose-containing and glucose-free hemodialysis day and freeday, and between the glucose-containing and glucose-free hemodialysis day and the freeday. Lastly comparisons are made between the glucose-containing and glucose-free hemodialysis day, and between the glucose-containing and glucose-free freeday. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Glucose above 10.0 mmol/l | In the end of a two-week period | Percentage of hyperglycemic values of continuous glucose monitoring during the whole glucose-containing and glucose-free hemodialysis day is compared to the whole glucose-containing and glucose-free freeday, respectively. Similar comparison is made between the whole glucose-containing and glucose-free hemodialysis day and between the whole glucose-containing and glucose-free freeday. |
| Glucose above 10.0 mmol/l during specified time intervals | In the end of a two-week period | Percentage of hyperglycemia during the specified time intervals is compared within the glucose-containing and glucose-free hemodialysis day and freeday, and between the glucose-containing and glucose-free hemodialysis day and the freeday. Lastly comparisons are made between the glucose-containing and glucose-free hemodialysis day, and between the glucose-containing and glucose-free freeday. |
| Mean glucose | In the end of a two-week period | Mean glucose of continuous glucose monitoring during the whole glucose-containing and glucose-free hemodialysis day is compared to the whole glucose-containing and glucose-free freeday, respectively. Similar comparison is made between the whole glucose-containing and glucose-free hemodialysis day and between the whole glucose-containing and glucose-free freeday. |
| Standard deviation of glucose during specified time intervals | In the end of a two-week period | Standard deviation of glucose during the specified time intervals is compared within the glucose-containing and glucose-free hemodialysis day and freeday, and between the glucose-containing and glucose-free hemodialysis day and the freeday. Lastly comparisons are made between the glucose-containing and glucose-free hemodialysis day, and between the glucose-containing and glucose-free freeday. |
| Standard deviation of glucose | In the end of a two-week period | Standard deviation of glucose of continuous glucose monitoring during the whole glucose-containing and glucose-free hemodialysis day is compared to the whole glucose-containing and glucose-free freeday, respectively. Similar comparison is made between the whole glucose-containing and glucose-free hemodialysis day and between the whole glucose-containing and glucose-free freeday. |
| Mean glucose during specified time intervals | In the end of a two-week period | Mean glucose during the specified time intervals is compared within the glucose-containing and glucose-free hemodialysis day and freeday, and between the glucose-containing and glucose-free hemodialysis day and the freeday. Lastly comparisons are made between the glucose-containing and glucose-free hemodialysis day, and between the glucose-containing and glucose-free freeday. |
Outcome results
None listed