Continuous glucose monitoring in patients on peritoneal dialysis
Research type
Research Study
Full title
Continuous glucose monitoring in peritoneal dialysis
IRAS ID
309244
Contact name
Jennifer Williams
Contact email
Sponsor organisation
Royal Devon University Healthcare NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Research Summary:
Diabetes is the most common cause of kidney failure in the UK. Most people with kidney failure require kidney replacement therapy. Peritoneal dialysis is a form of kidney replacement therapy where the lining of the patients abdomen is used as a dialysis membrane.
In patients without significant kidney disease good diabetes control has been shown to be very important in preventing strokes, heart attacks and death from cardiovascular disease. Very little comparable research has been done in patients on peritoneal dialysis. This is partly because the standard blood tests that measure diabetes control are not as reliable in these patients.
Continuous glucose monitors (CGM) are widely used by people with diabetes. These monitors are attached to the skin of the upper arm, sugar levels are automatically measured at regular intervals for up to 10 days. These monitors provide doctors and patients with a lot more information about their diabetic control than traditional blood tests. CGMs are popular with patients as they reduce the number of painful finger prick blood sugar tests that need to be done. CGMs currently cannot be used in patients on peritoneal dialysis as no studies have been done to show that they are accurate in these patients.
We will conduct a study comparing results from CGMs with finger prick blood sugars and laboratory generated sugar levels. We will ask 15 people with diabetes who are on peritoneal dialysis to wear two CGM devices for 10 days and do 5 finger prick sugars per day. They will come to the research facility for half a day to collect blood samples that can be analysed in the laboratory. The results will be compared to see if the CGM is an accurate and reliable method of measuring blood sugar in these patients.
Summary of Results:
Peritoneal dialysis (PD) is a treatment for end stage kidney failure. Many people with kidney failure also have diabetes. New technology which allows continuous monitoring of blood sugar levels without repeated painful finger prick tests is not currently licensed for use in people on PD as their accuracy has not been thoroughly tested in this group of people.
This study aimed to test the accuracy of the FreeStyle Libre (FSL) continuous glucose monitor in people who have diabetes and are on PD.
To do this we wanted to compare the FSL to 2 standard measures of blood sugar. We recruited 12 participants who wore the FSL for 10 days. During this time they checked their blood sugars at home 5 times per day using a finger prick monitor. They also came to the research facility to have blood sugar measured on a laboratory machine.
We compared the readings from the FSL with both the finger prick tests and the laboratory tests to see how accurate it was.
We were able to compare 84 pairs of readings for the laboratory tests and 416 pairs of readings from the finger prick tests.
We found that on average the relative difference between the FSL and laboratory readings was 9.8%. The relative difference between the FSL and the finger prick readings was higher at 17.3%. Using an error grid we plotted out how differences between the FSL and either of the standard measures of blood sugar might affect a persons clinical treatment. On our plot 99.9% of our paired readings were in the 2 clinically acceptable zones, meaning that any differences would not have had a significant or dangerous impact on a persons treatment.
These results were generally reassuring with regards using this new technology in the care of people with diabetes who are also on PD. However it is a small study and larger studies are needed to further confirm these results.REC name
London - West London & GTAC Research Ethics Committee
REC reference
22/PR/0723
Date of REC Opinion
9 Jun 2022
REC opinion
Favourable Opinion