Evaluating glucose control before, during and after haemodialysis in patients with diabetes who are using insulin.

Rationale:

Glucose control in diabetic patients with end stage renal disease might be influenced by treatment with haemodialysis, but data on this subject are limited. Haemodialysis could affect glucose control through several mechanisms. It has been suggested that insulin is eliminated directly by the haemodialysis procedure itself. In addition, glucose control during haemodialysis could also be influenced by indirect mechanisms such as changes in food intake and physical activity.
Objective: The main objective is to compare glucose profiles recorded by continuous glucose monitoring (CGM) on days with and without haemodialysis in a group of insulin treated diabetic patients. Secondary objectives are to evaluate the relationship between food intake or physical activity and glucose profiles on days with and without haemodialysis and to examine the pharmacokinetics of insulin during haemodialysis.



Study design:

Short term invasive observational multicenter study.



Study population:

Adult patients (age=/> 18 years) with insulin treated diabetes undergoing regular haemodialysis treatment (n=20).



Main study parameters/endpoints:

Mean glucose concentration and area-under-the-curve (AUC) of glucose during 24-hour periods, frequency and severity of hypoglycaemic episodes, on days with and without haemodialysis.



Methods:

Glucose measurement by continuous glucose monitoring during 5 days. Food intake and hypoglycaemic episodes are recorded by the patients in a structured diary. Physical activity is monitored by means of a pedometer, except in those patients who are immobilised (e.g. leg amputation, paralysis). A subgroup of 10 diabetic patients also participates in a pharmacokinetics study. In these patients, blood samples for determination of glucose and insulin will be drawn before, during (at one hour intervals) and directly after one haemodialysis session simultaneously from the arterial and venous side of the haemodialysis unit. Dialysate will be sampled simultaneously for glucose measurement.

Glucose control in diabetic patients with end stage renal disease might be influenced by treatment with haemodialysis, but data on this subject are limited. Haemodialysis could affect glucose control through several mechanisms. It has been suggested that insulin is eliminated directly by the haemodialysis procedure itself. In addition, glucose control during haemodialysis could also be influenced by indirect mechanisms such as changes in food intake and physical activity.
The main objective of this study is to compare glucose profiles recorded by continuous glucose monitoring (CGM) on days with and without haemodialysis in a group of insulin treated diabetic patients. Secondary objectives are to evaluate the relationship between food intake or physical activity and glucose profiles on days with and without haemodialysis and to examine the pharmacokinetics of insulin during haemodialysis.

The observation period of each participant is 5 days, during which CGM takes place.

Continuous glucose monitoring (CGM) will be performed during 5 days in each participant. Participants receive regular daytime haemodialysis 3 times a week and CGM is started at the beginning of the first session of the week.