Continuous glucose monitoring in dialysis
| ISRCTN | ISRCTN95927934 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95927934 |
| Integrated Research Application System (IRAS) | 277881 |
| Central Portfolio Management System (CPMS) | 44772 |
| Sponsor | Abbott Diabetes Care Ltd |
| Funder | Abbott Diabetes Care Ltd |
- Submission date
- 20/07/2026
- Registration date
- 20/07/2026
- Last edited
- 05/08/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
This pilot study assessed how accurately two continuous glucose monitoring (CGM) systems measure glucose levels in adults with diabetes undergoing haemodialysis, compared with standard fingerprick blood glucose tests.
Who can participate?
Patients aged 18 years or over with type 1 or type 2 diabetes requiring insulin therapy who are on stable haemodialysis
What does the study involve?
Around 10 participants wore two sensors at the same time (one on the arm and one on the abdomen) for up to 10 days. They tested their blood glucose four times per day and scanned one sensor at the same time, while continuing their usual daily activities and dialysis sessions. After the study, participants returned for sensor removal and data collection. Sensor glucose readings were not visible, and diabetes management was based on fingerprick results.
What are the possible benefits and risks of participating?
There was no direct benefit to participants, but the study may improve understanding of these devices in people on haemodialysis. Risks were minimal and included skin irritation from the sensors and minor discomfort or bruising from fingerprick testing.
Where is the study run from?
Oxford University Hospitals NHS Foundation Trust, Churchill Hospital (UK)
When is the study starting and how long is it expected to run for?
November 2020 to March 2022
Who is funding the study?
Abbott Diabetes Care Ltd (UK)
Who is the main contact?
Dr Pamela Reid, pamela.reid@abbott.com
Contact information
Public, Scientific
Range Road
Witney
OX29 7YL
United Kingdom
| Phone | +44 (0)1993 863024 |
|---|---|
| pamela.reid@abbott.com |
Principal investigator
Churchill Hospital
Oxford
OX3 7LE
United Kingdom
| Phone | +44 (0)1865227795 |
|---|---|
| Thomas.Connor@ouh.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | N/A: single arm study |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Single |
| Purpose | Device feasibility |
| Scientific title | Continuous glucose monitoring system use in insulin-treated patients undergoing dialysis |
| Study objectives | This pilot study aims to evaluate two continuous glucose monitoring (CGM) systems in patients with diabetes undergoing haemodialysis. |
| Ethics approval(s) |
Approved 20/06/2020, Yorkshire & The Humber - Leeds West Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, United Kingdom; +44 (0)207 972 25 04; sheffield.rec@hra.nhs.uk), ref: 20/YH/0166 |
| Health condition(s) or problem(s) studied | People with diabetes undergoing haemodialysis |
| Intervention | Participants wear two different on-market glucose sensors concurrently for up to 10 days. Participants perform four daily fingerprick blood glucose measurements using the provided blood glucose meter. Glucose data from both sensors is blinded to participants and not used for glucose management. Only the fingerprick blood glucose results are visible to participants. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | FreeStyle Libre Flash Glucose Monitoring System, Dexcom G6 Continuous Glucose Monitoring System |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 14/03/2022 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 10 |
| Total final enrolment | 13 |
| Key inclusion criteria | 1. Aged 18 years or over 2. Type 1 or type 2 diabetes, requiring insulin therapy 3. Willing and able to test their blood glucose levels via fingerprick at least four times a day using the provided system 3. On stable haemodialysis (i.e., treatment using dialysis has been in progress for a minimum of 90 days) |
| Key exclusion criteria | 1. Concomitant disease or condition that may compromise patient safety 2. Currently prescribed oral steroid therapy for any acute or chronic condition 3. Female participant known to be pregnant 4. Have a pacemaker or any other neurostimulators 5. Known (or suspected) allergy to medical-grade adhesives |
| Date of first enrolment | 17/11/2020 |
| Date of final enrolment | 24/12/2020 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Oxford
OX3 7LE
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | version 1.0 | 01/07/2026 | 21/07/2026 | No | No |
| Plain English results | version 1.0 | 01/07/2026 | 21/07/2026 | No | Yes |
Additional files
- ISRCTN95927934_BasicResults_v1.0_01July2026.pdf
- Basic results
- ISRCTN95927934_PlainEnglishResults_v1.0_01July2026.pdf
- Plain English results
Editorial Notes
05/08/2026: Internal review.
21/07/2026: Basic results and plain English results were uploaded.
20/07/2026: Study's existence confirmed by the HRA.
