CompletedNot Applicable

Assessment of the Accuracy of Continuous Glucose Sensors in People With Diabetes Undergoing Haemodialysis

United Kingdom40 participantsStarted 2019-12-11

Plain-language summary

The purpose of the study is to assess the accuracy of the Dexcom G6 CGM system and the Abbott FreeStyle Libre flash system compared to the reference standard YSI (Yellow Spring Instruments) glucose in people with diabetes undergoing haemodialysis. The Dexcom G6 is a continuous glucose monitoring system that gives blood glucose values in real-time and includes alarms if the glucose is very low or high. The Abbott FreeStyle ibre flash system is an intermittent glucose monitor that shows the blood glucose values when it is waved near the sensor and does not include alarms. The YSI glucose analysis will take place as a normal part of haemodialysis, by testing blood glucose levels during the haemodialysis session. The study will last 28 days per participant

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults \>18 years of age * Diabetes, with insulin treatment for over 6 months or on sulphonylureas * Chronic kidney disease requiring haemodialysis three times per week Exclusion Criteria: * Pregnant or planning pregnancy * Breastfeeding * Enrolled in other clinical trials * Have active malignancy or under investigation for malignancy * Severe visual impairment * Reduced manual dexterity * Unable to participate due to other factors, as assessed by the Chief Investigators

What they're measuring

MARD between G6 and YSI

Timeframe: 28 days

MARD between Libre and YSI

Timeframe: 28 days

Trial details

NCT IDNCT03885362

SponsorImperial College London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-01

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