The 16-week trial is an open-label cross-over trial which includes heamodialysis patients with T2D and T1D on insulin therapy. During one period, patients carry a non-blinded CGM. In the other period they follow standard procedures (the last two weeks with a blinded CGM). The patients and the dialysis staff can use the CGM measures to regulate insulin and food intake during the non-blinded weeks. The research group will collect the CGM-data during the trial.
Background: Managing diabetes is often problematic in haemodialysis (HD) patients. Low blood glucose is especially common during treatment. Typically, the patient's blood sugar is only measured during treatment if considered relevant. Otherwise, HbA1c is used to control diabetes - a method associated with uncertain in HD patients. An alternative or supplement to the current management of diabetes could be CGM which enables closer observation and management of the diabetes disease. Despite the possibilities of using CGM, there are still few studies in the field which examine the importance of CGM data in relation to the management of diabetes in HD patients. Aims: To investigate whether the use of CGM data can prevent low blood sugar levels during HD and examins whether the use of CGM data can improve the management of diabetes in HD patients. Furthermore, it is found relevant to investigate if CGM data, selected blood test responses, treatment data, personal data and information about medicines can be used to predict low blood sugar during HD using an algorithm. Thus, the study also aims to develop and validate such an algorithm. Setting: The trial will be conducted at two dialysis wards (Aalborg and Hjørring) at Aalborg University Hospital. Subjects: Heamodialysis patients with T1D and T2D on insulin therapy. Study design: The 16-week trial is an open-label cross-over trial. During one period, patients carry a non-blinded CGM. In the other period they follow standard procedures (the last two weeks with a blinded CGM). The patients and the dialysis staff can use the CGM measures to regulate insulin and food intake during the non-blinded weeks. The research group will collect the CGM-data during the trial. The last four weeks include baseline measures (blinded CGM).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Acces to CGM data (not blinded CGM)
Department of nephrology (dialysis)
Aalborg, Denmark
time below range (CGM)
Change in time below range (CGM) (\< 3.0 mmol/L)
Time frame: 6 weeks of treatment in each of the two treatment periods
Time in range (CGM)
Change in time in range (CGM) (3,9-10,0 mmol/L)
Time frame: 6 weeks of treatment in each of the two treatment periods
Time in borderline low range (CGM)
Change in CGM time in low range(3.0 mmol/L ≤ glucose \< 3.9 mmol/L)
Time frame: 6 weeks of treatment in each of the two treatment periods
Time above range (CGM)
Change in CGM time above range (\>10 mmol/L)
Time frame: 6 weeks of treatment in each of the two treatment periods
Time above range (CGM) (high)
Change in CGM time above range (\>13,9 mmol/L)
Time frame: 6 weeks of treatment in each of the two treatment periods
Concentration of HbA1c
Change in HbA1c
Time frame: 6 weeks of treatment in each of the two treatment periods
Glucose variability
Glucose variability (variation coefficient or SD)
Time frame: 6 weeks of treatment in each of the two treatment periods
Sensitivity and specificity of algorithm
Sensitivity and specificity of algorithm to predict hypoglycemias
Time frame: Through study completion, an average of one year
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