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

• Sponsor: Aalborg University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05678712
• Collaborator: Steno Diabetes Center Nordjylland (Other), Aalborg University (Other)
• Enrollment: 29
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 22
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemodialysis; Type1diabetes; Type2Diabetes	Device: Access to CGM data (Dexcom G6)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Improved Glycemic Control in Diabetic Patients in Hemodialysis Using Continuous Glucose Monitoring (CGM)
• Actual Study Start Date: Mar 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. time below range (CGM) [6 weeks of treatment in each of the two treatment periods]

   Change in time below range (CGM) (< 3.0 mmol/L)

Secondary Outcome Measures

1. Time in range (CGM) [6 weeks of treatment in each of the two treatment periods]

   Change in time in range (CGM) (3,9-10,0 mmol/L)

2. Time in borderline low range (CGM) [6 weeks of treatment in each of the two treatment periods]

   Change in CGM time in low range(3.0 mmol/L ≤ glucose < 3.9 mmol/L)

3. Time above range (CGM) [6 weeks of treatment in each of the two treatment periods]

   Change in CGM time above range (>10 mmol/L)

4. Time above range (CGM) (high) [6 weeks of treatment in each of the two treatment periods]

   Change in CGM time above range (>13,9 mmol/L)

5. Concentration of HbA1c [6 weeks of treatment in each of the two treatment periods]

   Change in HbA1c

6. Glucose variability [6 weeks of treatment in each of the two treatment periods]

   Glucose variability (variation coefficient or SD)

7. Sensitivity and specificity of algorithm [Through study completion, an average of one year]

   Sensitivity and specificity of algorithm to predict hypoglycemias

Other Outcome Measures

1. Hypo- and hyperglycemic episodes [6 weeks of treatment in each of the two treatment periods]

   Number of hypo- and hyperglycemic episodes (15 minutes)

2. Insulin requirements [6 weeks of treatment in each of the two treatment periods]

   Changes in insulin requirements based on detection/memorisation (with help from nurse) of insulin doses and time points

3. Diabetes-related quality of life [Week 0, week 6, week 8, week 14]

   Assessing whether there is a difference between intervention and standard treatment. Measured using the Dawn-2 Impact of Diabetes Questionnaire (DIDP) questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of nephrology (dialysis)	Aalborg		Denmark	9000

Sponsors and Collaborators

• Aalborg University Hospital
• Steno Diabetes Center Nordjylland
• Aalborg University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peter Vestergaard, MD, professor, Aalborg University Hospital
• ClinicalTrials.gov Identifier: NCT05678712
• Other Study ID Numbers: N-20210070
• First Posted: Jan 10, 2023
• Last Update Posted: Jan 10, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Peter Vestergaard, MD, professor, Aalborg University Hospital: Diabetes; Heamodialysis; CGM; Glycemic control; Algorithm
• Additional relevant MeSH terms: Diabetes Mellitus

Study Results

No Results Posted as of Jan 10, 2023