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

NCT03885362 | Completed

• 1 other identifier: 18SM4938
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Diabetic Nephropathies; Type 1 Diabetes Mellitus; Chronic Kidney Diseases

Keywords

Type 1 Diabetes Mellitus; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (2)

• MARD between G6 and YSI

  Mean absolute relative difference between Dexcom G6 and YSI glucose during haemodialysis

  28 days

• MARD between Libre and YSI

  Mean absolute relative difference between Dexcom G6 and YSI glucose during haemodialysis

  28 days

Secondary Outcomes (17)

• HbA1c

  28 days

• MARD for G6 and YSI <3.9mmol/L

  28 days

• MARD for Libre and YSI <3.9mmol/L

  28 days

• MARD for Libre and YSI 3.9-10mmol/L

  28 days

• MARD for Libre and YSI >10mmol/L

  28 days

Study Arms (1)

Dexcom G6 and Abbott Freestyle Libre

EXPERIMENTAL

Participants will have a Dexcom G6 sensor and Abbott FreeStyle Libre sensor inserted in the abdomen and upper arm respectively. Participants will be asked to swipe the FreeStyle Libre reader across the sensor a minimum of every 8 hours. Participants will be asked to continue their usual regimen of self-monitoring capillary blood glucose (SMBG). During haemodialysis, a dialysis circuit blood sample will be drawn at 0 (pre-dialysis) 30, 60, 90, 120, 150, 180, 210 and 240 minutes and immediately after dialysis. Samples from the circuit will be analysed on the YSI glucose analyser. Participants will be asked to change the FreeStyle Libre sensors at day 14. The blinded CGM data will be uploaded at the time of each sensor change by the research team.

Device: Dexcom G6 and Abbott Freestyle Libre

Interventions

Dexcom G6 and Abbott Freestyle Libre DEVICE

Dexcom G6 - continuous glucose monitoring device - blinded. CE mark 2018 Abbott Freestyle Libre - flash glucose monitoring device. CE mark 2014

Dexcom G6 and Abbott Freestyle Libre

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College London/NHS trust Renal Unit

London, United Kingdom

Location

Related Publications (11)

• Coresh J, Selvin E, Stevens LA, Manzi J, Kusek JW, Eggers P, Van Lente F, Levey AS. Prevalence of chronic kidney disease in the United States. JAMA. 2007 Nov 7;298(17):2038-47. doi: 10.1001/jama.298.17.2038.

  PMID: 17986697 BACKGROUND

• Levin A. Clinical epidemiology of cardiovascular disease in chronic kidney disease prior to dialysis. Semin Dial. 2003 Mar-Apr;16(2):101-5. doi: 10.1046/j.1525-139x.2003.16025.x.

  PMID: 12641872 BACKGROUND

• Creme D, McCafferty K. Glycaemic Control Impact on Renal Endpoints in Diabetic Patients on Haemodialysis. Int J Nephrol. 2015;2015:523521. doi: 10.1155/2015/523521. Epub 2015 Sep 20.

  PMID: 26457201 BACKGROUND

• National Kidney Foundation. KDOQI Clinical Practice Guideline for Diabetes and CKD: 2012 Update. Am J Kidney Dis. 2012 Nov;60(5):850-86. doi: 10.1053/j.ajkd.2012.07.005.

  PMID: 23067652 BACKGROUND

• Haviv YS, Sharkia M, Safadi R. Hypoglycemia in patients with renal failure. Ren Fail. 2000 Mar;22(2):219-23. doi: 10.1081/jdi-100100866.

  PMID: 10803766 BACKGROUND

• Lee KF, Szeto YT, Benzie IF. Glycohaemoglobin measurement: methodological differences in relation to interference by urea. Acta Diabetol. 2002 Apr;39(1):35-9. doi: 10.1007/s005920200010.

  PMID: 12043937 BACKGROUND

• Inaba M, Okuno S, Kumeda Y, Yamada S, Imanishi Y, Tabata T, Okamura M, Okada S, Yamakawa T, Ishimura E, Nishizawa Y; Osaka CKD Expert Research Group. Glycated albumin is a better glycemic indicator than glycated hemoglobin values in hemodialysis patients with diabetes: effect of anemia and erythropoietin injection. J Am Soc Nephrol. 2007 Mar;18(3):896-903. doi: 10.1681/ASN.2006070772. Epub 2007 Jan 31.

  PMID: 17267743 BACKGROUND

• Joy MS, Cefalu WT, Hogan SL, Nachman PH. Long-term glycemic control measurements in diabetic patients receiving hemodialysis. Am J Kidney Dis. 2002 Feb;39(2):297-307. doi: 10.1053/ajkd.2002.30549.

  PMID: 11840370 BACKGROUND

• Pickup JC, Freeman SC, Sutton AJ. Glycaemic control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blood glucose: meta-analysis of randomised controlled trials using individual patient data. BMJ. 2011 Jul 7;343:d3805. doi: 10.1136/bmj.d3805.

  PMID: 21737469 BACKGROUND

• Beck RW, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S, Kollman C, Kruger D, McGill JB, Polonsky W, Toschi E, Wolpert H, Price D; DIAMOND Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):371-378. doi: 10.1001/jama.2016.19975.

  PMID: 28118453 BACKGROUND

• Lind M, Polonsky W, Hirsch IB, Heise T, Bolinder J, Dahlqvist S, Schwarz E, Olafsdottir AF, Frid A, Wedel H, Ahlen E, Nystrom T, Hellman J. Continuous Glucose Monitoring vs Conventional Therapy for Glycemic Control in Adults With Type 1 Diabetes Treated With Multiple Daily Insulin Injections: The GOLD Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):379-387. doi: 10.1001/jama.2016.19976.

  PMID: 28118454 BACKGROUND

MeSH Terms

Conditions

Diabetic Nephropathies; Diabetes Mellitus, Type 1; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nick Oliver

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Blinded CGM but not Libre
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: March 21, 2019
• Study Start: December 11, 2019
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)