Improved Glycemic Control in Diabetic Patients in Hemodialysis Using Continuous Glucose Monitoring (CGM)

Study Overview
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Brief Summary
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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
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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).

Official Title
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Improved Glycemic Control in Diabetic Patients in Hemodialysis Using Continuous Glucose Monitoring (CGM)

Conditions
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Hemodialysis, Type1diabetes, Type2Diabetes

Intervention / Treatment
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* Device: Access to CGM data (Dexcom G6)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard treatment<br>After a two weeks run-in baseline period (blinded CGM) some of the participants (1:1) were randomly assigned to six weeks of standard treatment, i.e. self monitoring of blood glucose (the last two weeks with blinded CGM → 2 weeks wash-out (baseline for next period) (blinded CGM) → six weeks with non-blinded CGM with data available for the patient himself/herself and dialysis staff | |
| Experimental: Intervention (access to CGM data)<br>After a two weeks run-in baseline period (blinded CGM) some of the participants (1:1) were randomly assigned to six weeks with non-blinded CGM with data available for the patient himself/herself and dialysis staff → 2 weeks wash-out (baseline for next period) (blinded CGM) → Six weeks of standard treatment, i.e. self monitoring of blood glucose (the last two weeks with blinded CGM | Device: Access to CGM data (Dexcom G6)<br>* Acces to CGM data (not blinded CGM)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time below range (CGM) | Change in time below range (CGM) (< 3.0 mmol/L) | 6 weeks of treatment in each of the two treatment periods | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in range (CGM) | Change in time in range (CGM) (3,9-10,0 mmol/L) | 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) | 6 weeks of treatment in each of the two treatment periods | 
| Time above range (CGM) | Change in CGM time above range (>10 mmol/L) | 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) | 6 weeks of treatment in each of the two treatment periods | 
| Concentration of HbA1c | Change in HbA1c | 6 weeks of treatment in each of the two treatment periods | 
| Glucose variability | Glucose variability (variation coefficient or SD) | 6 weeks of treatment in each of the two treatment periods | 
| Sensitivity and specificity of algorithm | Sensitivity and specificity of algorithm to predict hypoglycemias | Through study completion, an average of one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Heamodialysis, CGM, Glycemic control, Algorithm