ALPHA

• Research type

  Research Study

• Full title

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

• IRAS ID

  253404

• Contact name

  Nick Oliver

• Contact email

  nick.oliver@imperial.ac.uk

• Sponsor organisation

  Imperial College London

• Duration of Study in the UK

  0 years, 6 months, 1 days

• Research 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 Libre 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.

  This study examined the accuracy of continuous glucose monitoring (CGM) sensors in people with diabetes who are undergoing haemodialysis. CGM devices, which measure glucose levels through a sensor worn on the body, are commonly used by people with type 1 diabetes and some with type 2 diabetes. However, there is limited information on how well these sensors work for individuals on dialysis.

  The study was conducted in two phases with adults with diabetes who regularly attend haemodialysis sessions. All participants were using insulin or medication to lower their blood glucose. During the dialysis sessions, glucose readings were taken from both sensors at the same time, alongside blood glucose samples that were analysed using a reference standard.

  In phase 1, the study evaluated two commonly used glucose sensors, the Dexcom G6 and Abbott Freestyle Libre 1. Forty adults with diabetes on haemodialysis participated, with over 2500 matched samples analysed for each sensor. The Freestyle Libre 1 readings closely matched the laboratory results and proved reliable during dialysis. The Dexcom G6 readings showed greater differences, though most remained within safe ranges for making treatment decisions (as determined by the Clarke Error Grid analyses).

  In phase 2, the study assessed the newer Dexcom G7 sensor. Ten adults with diabetes who were on haemodialysis took part, with 720 matched samples analysed in total. The Dexcom G7 readings closely matched the laboratory results, with almost all readings falling within clinically safe and accurate ranges.

  In conclusion, the Freestyle Libre 1 and Dexcom G7 provided accurate and reliable glucose information in haemodialysis settings. The older Dexcom G6 performed less well during dialysis, and further studies are needed for this group of people. Overall, the findings support the use of newer glucose monitoring technologies to enhance diabetes care for people undergoing haemodialysis.

  Published manuscripts:
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fpubmed.ncbi.nlm.nih.gov%252F36961385%252F%2FNBTI%2Feg3CAQ%2FAQ%2F15bce81f-f3fa-4b36-a54e-41967a8f6911%2F1%2FbEejiIENUf&data=05%7C02%7Cbromley.rec%40hra.nhs.uk%7C5474105a614a4cc5bf4508de3bbc732c%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639013877766356319%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=SUGABve6pntw5Z18lfCuxFgzA7DgSPWcofC%2BCvZkndY%3D&reserved=0
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fpubmed.ncbi.nlm.nih.gov%252F39788885%252F%2FNBTI%2Feg3CAQ%2FAQ%2F15bce81f-f3fa-4b36-a54e-41967a8f6911%2F2%2F6mzQSzm2k7&data=05%7C02%7Cbromley.rec%40hra.nhs.uk%7C5474105a614a4cc5bf4508de3bbc732c%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639013877766393362%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=rSJJQzkP51xQl4hEGcHPu0OLCsE4oEUtA0d1RHS7rNY%3D&reserved=0
  

• REC name

  London - Bromley Research Ethics Committee

• REC reference

  19/LO/0431

• Date of REC Opinion

  31 May 2019

• REC opinion

  Further Information Favourable Opinion