HemodialysisNCT05678712
Improved Glycemic Control in Diabetic Patients in Hemodialysis Using Continuous Glucose Monitoring (CGM)
A study testing Access to CGM data (Dexcom G6) in people with Hemodialysis and Type1diabetes, run by Aalborg University Hospital at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, Type1diabetes, Type2Diabetes
- What is being tested?
- Access to CGM data (Dexcom G6)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Mar 2022to 18 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Hemodialysis, Type1diabetes, Type2Diabetes
- Being tested
- Access to CGM data (Dexcom G6)
- Keywords
- Diabetes, Heamodialysis, CGM, Glycemic control, Algorithm
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to CGM data (Dexcom G6)Device
Acces to CGM data (not blinded CGM)
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | No intervention | 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 |
| Intervention (access to CGM data) | Experimental | 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 Receives: Device: Access to CGM data (Dexcom G6) |
What is being measured
The primary outcome is the main question the study is designed to answer.
time below range (CGM)
Change in time below range (CGM) (< 3.0 mmol/L)
Measured: 6 weeks of treatment in each of the two treatment periods
Secondary outcomes (7)
Time in range (CGM)
Change in time in range (CGM) (3,9-10,0 mmol/L)
Measured: 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)
Measured: 6 weeks of treatment in each of the two treatment periods
Time above range (CGM)
Change in CGM time above range (>10 mmol/L)
Measured: 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)
Measured: 6 weeks of treatment in each of the two treatment periods
Concentration of HbA1c
Change in HbA1c
Measured: 6 weeks of treatment in each of the two treatment periods
Glucose variability
Glucose variability (variation coefficient or SD)
Measured: 6 weeks of treatment in each of the two treatment periods
Sensitivity and specificity of algorithm
Sensitivity and specificity of algorithm to predict hypoglycemias
Measured: Through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start9 Mar 2022
- Primary completion18 Dec 2023
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Steno Diabetes Center Nordjylland, Aalborg University
- Responsible party
- Principal investigator, Peter Vestergaard, Aalborg University Hospital
- Investigators
- Sisse Heiden Laursen, PhD, Principal investigator, Aalborg UniversityPeter Vestergaard, PhD (and MD), Study chair, Aalborg University Hospital and Steno Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678712
- Sponsor's protocol ID
- N-20210070
- Status last verified
- Jan 2024
- First submitted
- 4 Mar 2022
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Glycemic Control in Diabetic Patients in Hemodialysis Using Continuous Glucose Monitoring (CGM)
- ClinicalTrials.gov ID
- NCT05678712
- Acronym / sponsor ID
- N-20210070
- Conditions
- Hemodialysis, Type1diabetes, Type2Diabetes
- Keywords
- Diabetes, Heamodialysis, CGM, Glycemic control, Algorithm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Steno Diabetes Center Nordjylland, Aalborg University
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | No intervention | –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 |
| Intervention (access to CGM data) | Experimental | Device: Access to CGM data (Dexcom G6)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Access to CGM data (Dexcom G6)Acces to CGM data (not blinded CGM) | Device | Intervention (access to CGM data) |
Primary outcome
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)
7 secondary outcomes
Time in range (CGM)
Time frame: 6 weeks of treatment in each of the two treatment periods
Time in borderline low range (CGM)
Time frame: 6 weeks of treatment in each of the two treatment periods
Time above range (CGM)
Time frame: 6 weeks of treatment in each of the two treatment periods
Time above range (CGM) (high)
Time frame: 6 weeks of treatment in each of the two treatment periods
Concentration of HbA1c
Time frame: 6 weeks of treatment in each of the two treatment periods
Glucose variability
Time frame: 6 weeks of treatment in each of the two treatment periods
Sensitivity and specificity of algorithm
Time frame: Through study completion, an average of one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sisse Heiden Laursen, PhD principal investigator
Aalborg University
Peter Vestergaard, PhD (and MD) study chair
Aalborg University Hospital and Steno Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access to CGM data (Dexcom G6) in people with Hemodialysis and Type1diabetes, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time below range (CGM) (time frame: 6 weeks of treatment in each of the two treatment periods). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.