- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05678712
Improved Glycemic Control in Diabetic Patients in Hemodialysis Using Continuous Glucose Monitoring (CGM)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
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
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-
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Aalborg, Denmark, 9000
- Department of nephrology (dialysis)
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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)
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
|
Acces to CGM data (not blinded CGM)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
time below range (CGM)
Time Frame: 6 weeks of treatment in each of the two treatment periods
|
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)
Time Frame: 6 weeks of treatment in each of the two treatment periods
|
Change in time in range (CGM) (3,9-10,0 mmol/L)
|
6 weeks of treatment in each of the two treatment periods
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Time in borderline low range (CGM)
Time Frame: 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)
|
6 weeks of treatment in each of the two treatment periods
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Time above range (CGM)
Time Frame: 6 weeks of treatment in each of the two treatment periods
|
Change in CGM time above range (>10 mmol/L)
|
6 weeks of treatment in each of the two treatment periods
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Time above range (CGM) (high)
Time Frame: 6 weeks of treatment in each of the two treatment periods
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Change in CGM time above range (>13,9 mmol/L)
|
6 weeks of treatment in each of the two treatment periods
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Concentration of HbA1c
Time Frame: 6 weeks of treatment in each of the two treatment periods
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Change in HbA1c
|
6 weeks of treatment in each of the two treatment periods
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Glucose variability
Time Frame: 6 weeks of treatment in each of the two treatment periods
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Glucose variability (variation coefficient or SD)
|
6 weeks of treatment in each of the two treatment periods
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Sensitivity and specificity of algorithm
Time Frame: Through study completion, an average of one year
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Sensitivity and specificity of algorithm to predict hypoglycemias
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Through study completion, an average of one year
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hypo- and hyperglycemic episodes
Time Frame: 6 weeks of treatment in each of the two treatment periods
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Number of hypo- and hyperglycemic episodes (15 minutes)
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6 weeks of treatment in each of the two treatment periods
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Insulin requirements
Time Frame: 6 weeks of treatment in each of the two treatment periods
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Changes in insulin requirements based on detection/memorisation (with help from nurse) of insulin doses and time points
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6 weeks of treatment in each of the two treatment periods
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Diabetes-related quality of life
Time Frame: Week 0, week 6, week 8, week 14
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Assessing whether there is a difference between intervention and standard treatment.
Measured using the Dawn-2 Impact of Diabetes Questionnaire (DIDP) questionnaire
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Week 0, week 6, week 8, week 14
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Collaborators and Investigators
Sponsor
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)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- N-20210070
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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