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

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.

Study Overview

• Status: Completed
• Conditions: Type1diabetes; Hemodialysis; Type2Diabetes
• Intervention / Treatment: Device: Access to CGM data (Dexcom G6)

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).

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sisse H Laursen, PhD; Phone Number: +72691206; Email: sih@hst.aau.dk
• Study Contact Backup: Name: Morten H Jensen, PhD; Phone Number: +4522226964; Email: mhj@hst.aau.dk

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Department of nephrology (dialysis)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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
Experimental: 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	Device: Access to CGM data (Dexcom G6); Acces to CGM data (not blinded CGM)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypo- and hyperglycemic episodes	Number of hypo- and hyperglycemic episodes (15 minutes)	6 weeks of treatment in each of the two treatment periods
Insulin requirements	Changes in insulin requirements based on detection/memorisation (with help from nurse) of insulin doses and time points	6 weeks of treatment in each of the two treatment periods
Diabetes-related quality of life	Assessing whether there is a difference between intervention and standard treatment. Measured using the Dawn-2 Impact of Diabetes Questionnaire (DIDP) questionnaire	Week 0, week 6, week 8, week 14

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Collaborators: Aalborg University; Steno Diabetes Center Nordjylland
• Investigators: Principal Investigator: Sisse Heiden Laursen, PhD, Aalborg University; Study Chair: Peter Vestergaard, PhD (and MD), Aalborg University Hospital and Steno Diabetes Center

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2022
• Primary Completion (Actual): December 18, 2023
• Study Completion (Actual): December 18, 2023

Study Registration Dates

• First Submitted: March 4, 2022
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes; CGM; Glycemic control; Algorithm; Heamodialysis
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: N-20210070

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No