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

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ClinicalTrials.gov Identifier: NCT03885362
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Imperial College London

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

Condition or disease Intervention/treatment Phase
Diabetic Nephropathies Type 1 Diabetes Mellitus Chronic Kidney Diseases Device: Dexcom G6 and Abbott Freestyle Libre Not Applicable

Detailed Description:

Diabetic nephropathy is the leading cause of end-stage renal failure (ESRF), representing approximately 40% of people requiring long-term renal replacement therapy and maintenance haemodialysis [1]. Mortality and morbidity within this cohort is high, with the predominant cause being cardiovascular disease (CVD) [2]. Glycaemic control in many haemodialysis dependent patients with diabetes is poor and may lead to additional renal complications, including high interdialytic weight gain, electrolyte imbalance, and amputations [3]. Current clinical guidance is centred around the prevention of hyperglycaemia and microvascular complications of diabetes.

Glucose self-management is particularly challenging due to cyclical changes in insulin sensitivity and circulating insulin concentrations. Hypoglycemia is common due to impaired renal gluconeogenesis, malnutrition, and the increased half-life of insulin and hypoglycemic agents [4, 5]. Additionally, people with chronic kidney disease and diabetes may have other diabetes complications such as retinopathy, neuropathy, and impaired awareness of hypoglycaemia, which can make self-management more difficult.

Overall assessment of glycaemic control is also more complex as classical markers of glycemic control (i.e. HbA1c and fructosamine) may be misleading due to the variable underestimation of glycaemia resulting from analytical interferences, shortened half-life of red blood cells and abnormal albumin level [6-8]. Further limitations of HbA1c is that it is not informative regarding glycemic control on the days on and off dialysis, and intra-day glycaemic variability.

Frequent capillary blood glucose tests or self-monitoring of blood glucose (SMBG) is the traditional and one of the most effective ways to track an individuals' blood glucose levels. Real-time continuous glucose monitoring (CGM) has been shown to improve overall glucose control, reduce hypoglycaemia in people with an HbA1c <7.0%, and may reduce severe hypoglycaemia [9-11]. In addition, they provide alert and alarm features for hypo- and hyperglycaemia, and for times of rapid glucose change.

Flash glucose monitoring does not provide real-time data with alerts and alarms, but allows users to retrospectively review the preceding 8 hours of continuous glucose data, along with a contemporary estimated blood glucose value and trend line. The system consists of a subcutaneous sensor placed on the back of the upper arm, which measures glucose in the interstitial fluid every minute. The glucose data are made available when the user chooses to swipe the reader over the sensor.

CGM has the potential to reduce HbA1c and minimize exposure to hypoglycaemia while addressing diabetes distress. Flash glucose monitoring may reduce exposure to hypoglycaemia in people with insulin-treated diabetes.

The accuracy of CGM and flash in people with diabetes on haemodialysis has not been described. In this clinical study, we will assess the accuracy of the Dexcom G6 CGM system and the Abbott FreeStyle Libre flash system compared to YSI (Yellow Spring Instruments) glucose in people undergoing haemodialysis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Blinded CGM but not Libre
Primary Purpose: Prevention
Official Title: Assessment of the Accuracy of Continuous Glucose Sensors in People With Diabetes Undergoing Haemodialysis
Actual Study Start Date : December 11, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: Dexcom G6 and Abbott Freestyle Libre

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




Primary Outcome Measures :
  1. MARD between G6 and YSI [ Time Frame: 28 days ]
    Mean absolute relative difference between Dexcom G6 and YSI glucose during haemodialysis

  2. MARD between Libre and YSI [ Time Frame: 28 days ]
    Mean absolute relative difference between Dexcom G6 and YSI glucose during haemodialysis


Secondary Outcome Measures :
  1. HbA1c [ Time Frame: 28 days ]
    Glycated Haemoglobin

  2. MARD for G6 and YSI <3.9mmol/L [ Time Frame: 28 days ]
    Mean absolute relative difference between Dexcom G6 and YSI glucose <3.9mmol/L

  3. MARD for Libre and YSI <3.9mmol/L [ Time Frame: 28 days ]
    Mean absolute relative difference between Libre and YSI glucose <3.9mmol/L

  4. MARD for Libre and YSI 3.9-10mmol/L [ Time Frame: 28 days ]
    Mean absolute relative difference between Libre and YSI glucose 3.9-10mmol/L

  5. MARD for Libre and YSI >10mmol/L [ Time Frame: 28 days ]
    Mean absolute relative difference between Libre and YSI glucose >10mmol/L

  6. MARD for G6 and YSI 3.9-10mmol/L [ Time Frame: 28 days ]
    Mean absolute relative difference between Dexcom G6 and YSI glucose 3.9-10mmol/L

  7. MARD for G6 and YSI >10mmol/L [ Time Frame: 28 days ]
    Mean absolute relative difference between Dexcom G6 and YSI glucose >10mmol/L

  8. MARD for G6 and YSI 24hr pre [ Time Frame: 24 hours ]
    Mean absolute relative difference between Dexcom G6 and YSI glucose during 24 hours prior to heamodialysis

  9. MARD for Libre and YSI 24hr pre [ Time Frame: 24 hours ]
    Mean absolute relative difference between Libre and YSI glucose during 24 hours prior to heamodialysis

  10. MARD for Libre and YSI 24hr post [ Time Frame: 24 hours ]
    Mean absolute relative difference between Libre and YSI glucose during 24 hours after heamodialysis

  11. MARD for G6 and YSI 24hr post [ Time Frame: 24 hours ]
    Mean absolute relative difference between Dexcom G6 and YSI glucose during 24 hours after heamodialysis

  12. CEG analysis G6 and YSI [ Time Frame: 28 DAYS ]
    Clarke Error Grid analysis between Dexcom G6 and YSI glucose during haemodialysis

  13. CEG analysis Libre and YSI [ Time Frame: 28 DAYS ]
    Clarke Error Grid analysis between Libre and YSI glucose during haemodialysis

  14. Severe hypoglycaemia [ Time Frame: 28 days ]
    Episodes of severe hypoglycaemia

  15. DKA [ Time Frame: 28 days ]
    Diabetic Ketoacidosis

  16. Sensor failure [ Time Frame: 28 days ]
    Events of G6/libre sensor failure

  17. Missing glucose data [ Time Frame: 28 days ]
    Missing blood glucose data for G6/libre measured by number of missing data points



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885362


Contacts
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Contact: Nick Oliver 0207 594 2460 nick.oliver@imperial.ac.uk

Locations
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United Kingdom
Imperial College London/NHS trust Renal Unit Recruiting
London, United Kingdom
Contact: Nick Oliver, FRCP    0207 594 2460    nick.oliver@imperial.ac.uk   
Principal Investigator: Nick Oliver         
Sub-Investigator: Tricia Tan         
Sub-Investigator: Andrew Frankel         
Sub-Investigator: Jo Reed         
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Nick Oliver Imperial College London
Publications:

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03885362    
Other Study ID Numbers: 18SM4938
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Type 1 Diabetes Mellitus
Chronic Kidney Diseases
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Diabetic Nephropathies
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Renal Insufficiency
Diabetes Complications