Continuous Glucose Monitoring in Haemodialysis and Peritoneal Dialysis Patients With Type 1 and Type 2 Diabetes

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The primary objective of this multicenter, randomized controlled trial is to assess whether the intermittent or continuous use of continous glucose monitoring can enhance glycaemic control among dialysis patients with type 1 or type 2 diabetes, in comparison to the standard monitoring involving finger-prick glucose and HbA1c. Participants will be monitored for 9 months and randomly assigned to one of three groups: * Group 1, the control group, will undergo standard monitoring (using HbA1c and BGM) along with double-blinded CGM sessions at month 0, 3, 6, and 9. * Group 2 will have intermittent access to open CGM during the same time intervals. * Group 3 will have continuous access to open CGM throughout the entire duration of the study. During the study period, participants will have three consultations with an endocrinologist for adjustments in their glucose-lowering treatment. The goal is to compare markers of glycaemic control between the three groups. Secondary objectives include evaluating the impact on hypoglycaemia, quality of life, hospitals admissions and cardiovascular events.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Written informed consent obtained before any trial-related procedures are performed

• Diabetes, one of the following groups: Type 1 diabetes OR Type 2 diabetes receiving glucose-lowering therapy OR Type 2 diabetes managed with lifestyle changes with an HbA1c ≥ 50 mmol/mol

• Maintenance haemodialysis or peritoneal dialysis (minimum of two weeks)

• Subject must be willing and able to comply with trial protocol and be fluent in Danish or English

Locations
Other Locations
Denmark
Rigshospitalet
RECRUITING
Copenhagen
Herlev Hospital
NOT_YET_RECRUITING
Herlev
North Zealand Hospital, Hillerød
NOT_YET_RECRUITING
Hillerød
Holbæk Sygehus
NOT_YET_RECRUITING
Holbæk
Zealand University Hospital
NOT_YET_RECRUITING
Roskilde
Contact Information
Primary
Christine LM Olesen, MD
Christine.Olesen@regionh.dk
21495144
Backup
Tobias Bomholt, MD, PhD
Tobias.bomholt@regionh.dk
35457952
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 96
Treatments
No_intervention: Control group (Group 1)
Will undergo standard glycaemic monitoring (HbA1c and finger-prick glucose) along with 10 days double-blinded CGM sessions scheduled at months 0, 3, 6, and 9.~Glucose-lowering treatment is adjusted by an endocrinologist or a diabetes nurse at months 0, 3, and 6.~CGM data will be double-blinded, and treatment adjustments will be based on usual monitoring of HbA1c and finger-prick glucose.
Active_comparator: Intermittent CGM (Group 2)
Will have intermittent access to 10 days of open CGM scheduled at months 0, 3, 6 along with double-blinded CGM at month 9.~Glucose-lowering treatment is adjusted by an endocrinologist or a diabetes nurse at months 0, 3, and 6.~The objective is to adjust their glucose-lowering treatment to ensure patients spend less than 1% of their time with glucose levels below 3.9 mmol/L and more than 60% of the time within the target range (3.9 to 10.0 mmol/L).
Active_comparator: Continuous CGM (Group 3)
Will have continuous access to open CGM throughout the entire duration of the study from month 0-9.~Glucose-lowering treatment is adjusted by an endocrinologist or a diabetes nurse at months 0, 3, and 6.~The objective is to adjust their glucose-lowering treatment to ensure patients spend less than 1% of their time with glucose levels below 3.9 mmol/L and more than 60% of the time within the target range (3.9 to 10.0 mmol/L).
Sponsors
Collaborators: Steno Diabetes Center Copenhagen
Leads: Bo Feldt-Rasmussen

This content was sourced from clinicaltrials.gov