Clinical trial NCT05678712: Improved Glycemic Control in Diabetic Patients in Hemodialysis Using Continuous Glucose Monitoring (CGM)
Official title: Improved Glycemic Control in Diabetic Patients in Hemodialysis Using Continuous Glucose Monitoring (CGM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Type1diabetes
Type2Diabetes
Keywords: Diabetes
Heamodialysis
CGM
Glycemic control
Algorithm
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Steno Diabetes Center Nordjylland
name: Aalborg University
First posted: 2023-01-10
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: time below range (CGM)
timeFrame: 6 weeks of treatment in each of the two treatment periods
Secondary outcomes:
measure: Time in range (CGM)
timeFrame: 6 weeks of treatment in each of the two treatment periods
measure: Time in borderline low range (CGM)
timeFrame: 6 weeks of treatment in each of the two treatment periods
measure: Time above range (CGM)
timeFrame: 6 weeks of treatment in each of the two treatment periods
measure: Time above range (CGM) (high)
timeFrame: 6 weeks of treatment in each of the two treatment periods
measure: Concentration of HbA1c
timeFrame: 6 weeks of treatment in each of the two treatment periods
measure: Glucose variability
timeFrame: 6 weeks of treatment in each of the two treatment periods
measure: Sensitivity and specificity of algorithm
timeFrame: Through study completion, an average of one year
Other outcomes:
measure: Hypo- and hyperglycemic episodes
timeFrame: 6 weeks of treatment in each of the two treatment periods
measure: Insulin requirements
timeFrame: 6 weeks of treatment in each of the two treatment periods
measure: Diabetes-related quality of life
timeFrame: Week 0, week 6, week 8, week 14
Locations:
city: Aalborg
country: Denmark
facility: Department of nephrology (dialysis)
Study officials:
affiliation: Aalborg University
name: Sisse Heiden Laursen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aalborg University Hospital and Steno Diabetes Center
name: Peter Vestergaard, PhD (and MD)
role: STUDY_CHAIR
References: