Continuous Glucose Monitoring in Dialysis Patients With Diabetes

NCT06641765 | Active Not Recruiting FDA Device

• 1 other identifier: CGM-Dialysis study
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Continuous Glucose Monitoring; Haemodialysis; Peritoneal Dialysis

Keywords

Hypoglycaemia; Quality of life; Time-in-range; HbA1c; Diabetes; Dialysis

Outcome Measures

Primary Outcomes (1)

• Change in time-in-target-range (3.9-10 mmol/L) from baseline through to study end between the three groups.

  Evaluated by 10 days of CGM obtained at baseline, months 0, 3, 6, and 9.

  9 Months

Secondary Outcomes (16)

• Difference in percentage of participants reaching the goal of minimum of 60% of time-in-target-range (3.9-10 mmol/L) between the three groups.

  9 Months

• Change in time-in-range < 3 mmol/L from baseline through to study end between the three groups.

  9 Months

• Change in time-in-range < 3.9 mmol/L from baseline through to study end between the three groups.

  9 Months

• Change in time-in-range 3.9-7.8 mmol/L from baseline through to study end between the three groups.

  9 Months

• Change in time-in-range > 10 mmol/L from baseline through to study end between the three groups.

  9 Months

Other Outcomes (11)

• Difference in "Hypoglycaemia Fear Survey [HFS-II]" between the three groups

  9 Months

• Difference in "The Diabetes Treatment Satisfaction Questionnaire status" between the three groups

  9 Months

• Difference in "Gold Score" (Hypoglycaemia awareness) between the three groups

  9 Months

Study Arms (3)

Control group (Group 1)

NO INTERVENTION

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.

Intermittent CGM (Group 2)

ACTIVE COMPARATOR

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).

Device: Continous Glucose Monitoring

Continuous CGM (Group 3)

ACTIVE COMPARATOR

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).

Device: Continous Glucose Monitoring

Interventions

Continous Glucose Monitoring DEVICE

10 days of real time open access to Continous Glucose Monitoring - either at defined time intervals (Group 2) or continuously for 9 months (Group 3).

Also known as: Dexcom G7

Continuous CGM (Group 3); Intermittent CGM (Group 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Major allergy to tape/adhesives
• Women who are pregnant or planning pregnancy
• Ongoing use of CGM
• Ongoing use of insulin pump

Sponsors & Collaborators

• Bo Feldt-Rasmussen: lead
• Steno Diabetes Center Copenhagen: collaborator

Study Sites (5)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Herlev Hospital

Herlev, 2730, Denmark

Location

North Zealand Hospital, Hillerød

Hillerød, 3400, Denmark

Location

Holbæk Sygehus

Holbæk, 4300, Denmark

Location

Zealand University Hospital

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Hypoglycemia; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Tobias Bomholt, MD, PhD

  Department of Nephrology, Rigshospitalet, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, DMSc, Professor

Model Details: Multicentre, prospective, randomized controlled study.

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 15, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (5)