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

NCT ID: NCT05678712

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-09
• Study Completion Date: 2023-12-18

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).

Conditions

Hemodialysis; Type1diabetes; Type2Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard treatment

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention (access to CGM data)

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

Group Type: EXPERIMENTAL

Access to CGM data (Dexcom G6)

Intervention Type: DEVICE

Acces to CGM data (not blinded CGM)

Interventions

Access to CGM data (Dexcom G6)

Acces to CGM data (not blinded CGM)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Steno Diabetes Center Nordjylland

OTHER

Sponsor Role: collaborator

Aalborg University

OTHER

Sponsor Role: collaborator

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Peter Vestergaard

MD, professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sisse Heiden Laursen, PhD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University

Peter Vestergaard, PhD (and MD)

Role: STUDY_CHAIR

Aalborg University Hospital and Steno Diabetes Center

Locations

Department of nephrology (dialysis)

Aalborg, , Denmark

Countries

Denmark

Other Identifiers

N-20210070

Identifier Type: -

Identifier Source: org_study_id