Hemodialysis, Type1diabetes, Type2Diabetes
Conditions
Keywords
Diabetes, Heamodialysis, CGM, Glycemic control, Algorithm
Brief summary
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.
Detailed description
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).
Interventions
DEVICEAccess to CGM data (Dexcom G6)
Acces to CGM data (not blinded CGM)
Sponsors
Steno Diabetes Center Nordjylland
Aalborg University
Aalborg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 18 years * Chronically ill heamodialysis patients (heamodialysis or heamodiafiltration - treatment)der modtager HD- eller hæmodiafiltrationsbehandling på dialyseafsnit,-- * Patients at dialysis wards in Aalborg and Hjørring, Aalborg University Hospital (center and home patients) * T1D or T2D and in treatment with insulin * Being able to use CGM equipment * Signed consent
Exclusion criteria
* Pregnancy or breastfeeding, * Terms that, in the opinion of the investigator or subinvestigators, render the participant unfit to conduct the trial, including lack of understanding of the trial or lack of physical or cognitive ability to participate * Patients undergoing peritoneal dialysis (PD) or heamofiltration dialysis (HF) * Acute HD treatment * Gestational diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time below range (CGM) | 6 weeks of treatment in each of the two treatment periods | Change in time below range (CGM) (\< 3.0 mmol/L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time above range (CGM) | 6 weeks of treatment in each of the two treatment periods | Change in CGM time above range (\>10 mmol/L) |
| Concentration of HbA1c | 6 weeks of treatment in each of the two treatment periods | Change in HbA1c |
| Glucose variability | 6 weeks of treatment in each of the two treatment periods | Glucose variability (variation coefficient or SD) |
| Sensitivity and specificity of algorithm | Through study completion, an average of one year | Sensitivity and specificity of algorithm to predict hypoglycemias |
| Time in range (CGM) | 6 weeks of treatment in each of the two treatment periods | Change in time in range (CGM) (3,9-10,0 mmol/L) |
| Time in borderline low range (CGM) | 6 weeks of treatment in each of the two treatment periods | Change in CGM time in low range(3.0 mmol/L ≤ glucose \< 3.9 mmol/L) |
| Time above range (CGM) (high) | 6 weeks of treatment in each of the two treatment periods | Change in CGM time above range (\>13,9 mmol/L) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Diabetes-related quality of life | Week 0, week 6, week 8, week 14 | Assessing whether there is a difference between intervention and standard treatment. Measured using the Dawn-2 Impact of Diabetes Questionnaire (DIDP) questionnaire |
| Hypo- and hyperglycemic episodes | 6 weeks of treatment in each of the two treatment periods | Number of hypo- and hyperglycemic episodes (15 minutes) |
| Insulin requirements | 6 weeks of treatment in each of the two treatment periods | Changes in insulin requirements based on detection/memorisation (with help from nurse) of insulin doses and time points |
Countries
Denmark
Outcome results
None listed