Diabetes MellitusRECORDNCT06657508
Continuous Glucose Monitoring in People With Diabetes on Dialysis
An observational study of Diabetes Mellitus and End-Stage Renal Disease, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Continuous glucose monitoring is a sensor, which monitors glucose levels continuously throughout the day. In people with diabetes, especially those treated with insulin, this sensor helps guide the amount of treatment (such as insulin) required to maintain glucose within target. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, End-Stage Renal Disease
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Dec 2024to Oct 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Outpatient secondary care setting. The study population involves people living with diabetes and end-stage renal disease on dialysis (as per eligibility criteria) attending the Renal Unit at the University Hospitals of Derby and Burton NHS Foundation Trust.
Who may be able to join
- Age: ≥18 years (no upper age limit)
- People with insulin-treated diabetes who receive NHS funded continuous glucose monitoring as part of their routine clinical care
- Diabetes duration > 6 months
- People with end-stage renal disease established on dialysis (maintenance haemodialysis or peritoneal dialysis)
- Ability to give informed consent
Who cannot join
- Participation in other competing studies/clinical trials as determined by the study investigator
- Serious illness or events with life expectancy < 3 months or other significant illness which, in the opinion of the study clinician, precludes involvement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-World Evaluation of Continuous Glucose Monitoring Data in People With Diabetes and End-Stage Renal Disease Receiving Dialysis
Continuous glucose monitoring is a sensor, which monitors glucose levels continuously throughout the day. In people with diabetes, especially those treated with insulin, this sensor helps guide the amount of treatment (such as insulin) required to maintain glucose within target.
In dialysis, the glucose levels and insulin needs can change a lot because of the kidney failure and dialysis treatments.
The goal of this observational study is to describe the changes in glucose during and in between dialysis sessions over two weeks by using continuous glucose monitoring. The study will also explore whether there is a relationship between the trend of the glucose and fluid level changes during and in between dialysis treatments. Also, the study will assess whether there is a relationship between glucose levels and several long-term outcomes, such as admissions to the hospital, for up to five years.
Read the detailed description
This is a single-centre observational prospective study, which involves existing users of NHS funded continuous glucose monitoring (CGM) with insulin-treated diabetes mellitus (DM) and end-stage renal disease (ESRD) established on dialysis.
CGM is the standard of care for glucose monitoring in all people with type 1 DM and specific groups with type 2 DM in the United Kingdom.
The study aims to evaluate the association between glucose levels in people with diabetes who are on dialysis with short- and long-term clinical outcomes.
The study will address the following hypotheses:
- Dialysis causes fluctuation in CGM glucometrics during dialysis and in between dialysis periods.
- Dysglycaemia is associated with adverse short- and long-term outcomes in people with diabetes who are on dialysis.
The primary objective of the study is to describe glucose levels in the intradialytic and interdialytic periods, by accessing CGM-derived glucometrics over 2 weeks.
The secondary objectives of the study are as follows:
Short term outcomes:
- To understand the impact of dialysis on CGM glucometrics in intradialytic and interdialytic periods (maintenance haemodialysis or peritoneal dialysis) by using raw glucose data combined across multiple different sensors
- To investigate the association of glycaemic control (CGM data and HbA1c) with:
- Ultrafiltration volume (assessed via body weight change in the intradialytic period)
- Body composition (assessed by bioelectrical impedance analysis)
- Blood pressure
Long term outcomes:
- To investigate the association of CGM metrics (intradialytic and interdialytic periods and 14- and 90-day data) and HbA1c with long term outcomes (up to 5 years):
- Mortality
- Hospital admissions
- Cardiovascular events (acute myocardial infarction, stroke, acute or decompensated heart failure)
- New diabetic foot ulcer or peripheral vascular disease requiring intervention or amputations
- To compare CGM measures with HbA1c as a predictor of long-term outcomes as described above
- Conditions
- Diabetes Mellitus, End-Stage Renal Disease
- Keywords
- Diabetes mellitus, End-stage renal disease, End-stage kidney disease, Dialysis, Haemodialysis, Peritoneal dialysis, Kidney replacement therapy, Continuous Glucose Monitoring, Glucose fluctuations
- Medical subject headings
- Diabetes Mellitus, Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in continuous glucose monitoring % time in glucose range [3.9-10.0 mmol/l] between intradialytic and interdialytic periods
Measured: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Secondary outcomes (23)
Change in continuous glucose monitoring % time in tight glucose range [3.9-7.8 mmol/l] between intradialytic and interdialytic periods
Measured: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Change in continuous glucose monitoring % time above glucose range, level 1 [10.1-13.9 mmol/L] between intradialytic and interdialytic periods
Measured: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Change in continuous glucose monitoring % time above glucose range, level 2 [>13.9 mmol/l] between intradialytic and interdialytic periods
Measured: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Change in continuous glucose monitoring % time below glucose range, level 1 [3.0-3.8 mmol/l] between intradialytic and interdialytic periods
Measured: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Change in continuous glucose monitoring % time below glucose range, level 2 [<3.0 mmol/l] between intradialytic and interdialytic periods
Measured: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Change in continuous glucose monitoring average glucose between intradialytic and interdialytic periods
Measured: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Change in continuous glucose monitoring % coefficient of variation between intradialytic and interdialytic periods
Measured: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Change in continuous glucose monitoring Glucose management indicator (GMI) between intradialytic and interdialytic periods
Measured: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Relationship between continuous glucose monitoring metrics and baseline Gold score
The Gold score assesses hypoglycaemia awareness
Measured: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Relationship between continuous glucose monitoring metrics and baseline Diabetes Distress Scale [DDS-17] score
Measured: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Relationship between continuous glucose monitoring metrics and baseline Problem Areas in Diabetes [PAID] score
Measured: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Relationship between continuous glucose monitoring metrics and baseline Glucose Monitoring Satisfaction Survey [GMSS] score
Measured: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Relationship between continuous glucose monitoring metrics and baseline Hypoglycaemia Fear Survey-Version II Worry scale [HFS-II W] score
Measured: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Relationship between continuous glucose monitoring metrics and baseline Integrated Palliative Outcome Score [IPOS]-renal score
Measured: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Relationship between continuous glucose monitoring metrics and baseline Dialysis Thirst Inventory questionnaire score
Measured: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Relationship between glucose outcomes and body composition measures on dialysis days assessed by bioelectrical impedance analysis
Glucose outcomes include 14- and 90- day continuous glucose monitoring metrics at baseline, intradialytic and interdialytic continuous glucose monitoring metrics, baseline HbA1c
Measured: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Relationship between glucose outcomes and ultrafiltration volume during dialysis sessions assessed via body weight changes in the intradialytic period
Glucose outcomes include 14- and 90- day continuous glucose monitoring metrics at baseline, intradialytic and interdialytic continuous glucose monitoring metrics, baseline HbA1c
Measured: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Relationship between glucose outcomes and changes in blood pressure in the intradialytic period
Glucose outcomes include 14- and 90- day continuous glucose monitoring metrics at baseline, intradialytic and interdialytic continuous glucose monitoring metrics, baseline HbA1c.
Changes in blood pressure are assessed by measuring blood pressure prior to and post dialysis sessions
Measured: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Association between glucose outcomes and mortality
Glucose outcomes include 14- and 90- day continuous glucose monitoring metrics at baseline, baseline HbA1c, intradialytic and interdialytic continuous glucose monitoring metrics, 14- and 90- day continuous glucose monitoring metrics and HbA1c at month 3, 6, 9 and 12
Measured: From baseline to 5 years
Association between glucose outcomes and hospital admissions
Glucose outcomes include 14- and 90- day continuous glucose monitoring metrics at baseline, baseline HbA1c, intradialytic and interdialytic continuous glucose monitoring metrics, 14- and 90- day continuous glucose monitoring metrics and HbA1c at month 3, 6, 9 and 12
Measured: From baseline to 5 years
Association between glucose outcomes and cardiovascular outcomes
Glucose outcomes include 14- and 90- day continuous glucose monitoring metrics at baseline, baseline HbA1c, intradialytic and interdialytic continuous glucose monitoring metrics, 14- and 90- day continuous glucose monitoring metrics and HbA1c at month 3, 6, 9 and 12.
Cardiovascular outcomes include acute myocardial infarction, stroke, acute or decompensated heart failure
Measured: From baseline to 5 years
Association between glucose outcomes and new diabetic foot ulcer requiring intervention or amputation
Glucose outcomes include 14- and 90- day continuous glucose monitoring metrics at baseline, baseline HbA1c, intradialytic and interdialytic continuous glucose monitoring metrics, 14- and 90- day continuous glucose monitoring metrics and HbA1c at month 3, 6, 9 and 12
Measured: From baseline to 5 years
Association between glucose outcomes and new peripheral vascular disease requiring intervention or amputation
Glucose outcomes include 14- and 90- day continuous glucose monitoring metrics at baseline, baseline HbA1c, intradialytic and interdialytic continuous glucose monitoring metrics, 14- and 90- day continuous glucose monitoring metrics and HbA1c at month 3, 6, 9 and 12
Measured: From baseline to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start31 Dec 2024
- Primary completion28 Oct 2025
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657508
- Sponsor's protocol ID
- 24046
- Acronym
- RECORD
- Status last verified
- Apr 2026
- First submitted
- 23 Oct 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Evaluation of Continuous Glucose Monitoring Data in People With Diabetes and End-Stage Renal Disease Receiving Dialysis
- ClinicalTrials.gov ID
- NCT06657508
- Acronym / sponsor ID
- RECORD / 24046
- Conditions
- Diabetes Mellitus, End-Stage Renal Disease
- Keywords
- Diabetes mellitus, End-stage renal disease, End-stage kidney disease, Dialysis, Haemodialysis, Peritoneal dialysis, Kidney replacement therapy, Continuous Glucose Monitoring
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 28 Oct 2025 (actual)
- Study completion
- Oct 2030 (estimated)
- First posted
- 24 Oct 2024 (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.
Continuous glucose monitoring is a sensor, which monitors glucose levels continuously throughout the day. In people with diabetes, especially those treated with insulin, this sensor helps guide the amount of treatment (such as insulin) required to maintain glucose within target.
In dialysis, the glucose levels and insulin needs can change a lot because of the kidney failure and dialysis treatments.
The goal of this observational study is to describe the changes in glucose during and in between dialysis sessions over two weeks by using continuous glucose monitoring. The study will also explore whether there is a relationship between the trend of the glucose and fluid level changes during and in between dialysis treatments. Also, the study will assess whether there is a relationship between glucose levels and several long-term outcomes, such as admissions to the hospital, for up to five years.
Detailed description
This is a single-centre observational prospective study, which involves existing users of NHS funded continuous glucose monitoring (CGM) with insulin-treated diabetes mellitus (DM) and end-stage renal disease (ESRD) established on dialysis.
CGM is the standard of care for glucose monitoring in all people with type 1 DM and specific groups with type 2 DM in the United Kingdom.
The study aims to evaluate the association between glucose levels in people with diabetes who are on dialysis with short- and long-term clinical outcomes.
The study will address the following hypotheses:
- Dialysis causes fluctuation in CGM glucometrics during dialysis and in between dialysis periods.
- Dysglycaemia is associated with adverse short- and long-term outcomes in people with diabetes who are on dialysis.
The primary objective of the study is to describe glucose levels in the intradialytic and interdialytic periods, by accessing CGM-derived glucometrics over 2 weeks.
The secondary objectives of the study are as follows:
Short term outcomes:
- To understand the impact of dialysis on CGM glucometrics in intradialytic and interdialytic periods (maintenance haemodialysis or peritoneal dialysis) by using raw glucose data combined across multiple different sensors
- To investigate the association of glycaemic control (CGM data and HbA1c) with:
- Ultrafiltration volume (assessed via body weight change in the intradialytic period)
- Body composition (assessed by bioelectrical impedance analysis)
- Blood pressure
Long term outcomes:
- To investigate the association of CGM metrics (intradialytic and interdialytic periods and 14- and 90-day data) and HbA1c with long term outcomes (up to 5 years):
- Mortality
- Hospital admissions
- Cardiovascular events (acute myocardial infarction, stroke, acute or decompensated heart failure)
- New diabetic foot ulcer or peripheral vascular disease requiring intervention or amputations
- To compare CGM measures with HbA1c as a predictor of long-term outcomes as described above
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Outpatient secondary care setting. The study population involves people living with diabetes and end-stage renal disease on dialysis (as per eligibility criteria) attending the Renal Unit at the University Hospitals of Derby and Burton NHS Foundation Trust.
Key inclusion criteria (5 listed)
- Age: ≥18 years (no upper age limit)
- People with insulin-treated diabetes who receive NHS funded continuous glucose monitoring as part of their routine clinical care
- Diabetes duration > 6 months
- People with end-stage renal disease established on dialysis (maintenance haemodialysis or peritoneal dialysis)
- Ability to give informed consent
Key exclusion criteria (2 listed)
- Participation in other competing studies/clinical trials as determined by the study investigator
- Serious illness or events with life expectancy < 3 months or other significant illness which, in the opinion of the study clinician, precludes involvement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in continuous glucose monitoring % time in glucose range [3.9-10.0 mmol/l] between intradialytic and interdialytic periods
Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
23 secondary outcomes
Change in continuous glucose monitoring % time in tight glucose range [3.9-7.8 mmol/l] between intradialytic and interdialytic periods
Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Change in continuous glucose monitoring % time above glucose range, level 1 [10.1-13.9 mmol/L] between intradialytic and interdialytic periods
Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Change in continuous glucose monitoring % time above glucose range, level 2 [>13.9 mmol/l] between intradialytic and interdialytic periods
Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Change in continuous glucose monitoring % time below glucose range, level 1 [3.0-3.8 mmol/l] between intradialytic and interdialytic periods
Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Change in continuous glucose monitoring % time below glucose range, level 2 [<3.0 mmol/l] between intradialytic and interdialytic periods
Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Change in continuous glucose monitoring average glucose between intradialytic and interdialytic periods
Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Change in continuous glucose monitoring % coefficient of variation between intradialytic and interdialytic periods
Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Change in continuous glucose monitoring Glucose management indicator (GMI) between intradialytic and interdialytic periods
Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Relationship between continuous glucose monitoring metrics and baseline Gold score
Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Relationship between continuous glucose monitoring metrics and baseline Diabetes Distress Scale [DDS-17] score
Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Relationship between continuous glucose monitoring metrics and baseline Problem Areas in Diabetes [PAID] score
Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Relationship between continuous glucose monitoring metrics and baseline Glucose Monitoring Satisfaction Survey [GMSS] score
Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Relationship between continuous glucose monitoring metrics and baseline Hypoglycaemia Fear Survey-Version II Worry scale [HFS-II W] score
Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Relationship between continuous glucose monitoring metrics and baseline Integrated Palliative Outcome Score [IPOS]-renal score
Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Relationship between continuous glucose monitoring metrics and baseline Dialysis Thirst Inventory questionnaire score
Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Relationship between glucose outcomes and body composition measures on dialysis days assessed by bioelectrical impedance analysis
Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Relationship between glucose outcomes and ultrafiltration volume during dialysis sessions assessed via body weight changes in the intradialytic period
Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Relationship between glucose outcomes and changes in blood pressure in the intradialytic period
Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Association between glucose outcomes and mortality
Time frame: From baseline to 5 years
Association between glucose outcomes and hospital admissions
Time frame: From baseline to 5 years
Association between glucose outcomes and cardiovascular outcomes
Time frame: From baseline to 5 years
Association between glucose outcomes and new diabetic foot ulcer requiring intervention or amputation
Time frame: From baseline to 5 years
Association between glucose outcomes and new peripheral vascular disease requiring intervention or amputation
Time frame: From baseline to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and End-Stage Renal Disease, run by University of Nottingham at 1 site in United Kingdom.
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 5 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in continuous glucose monitoring % time in glucose range [3.9-10.0 mmol/l] between intradialytic and interdialytic periods (time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions). 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 29 Apr 2026.