Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 22, 2019
First Posted Date  ICMJE March 21, 2019
Last Update Posted Date October 22, 2020
Actual Study Start Date  ICMJE December 11, 2019
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
  • MARD between G6 and YSI [ Time Frame: 28 days ]
    Mean absolute relative difference between Dexcom G6 and YSI glucose during haemodialysis
  • MARD between Libre and YSI [ Time Frame: 28 days ]
    Mean absolute relative difference between Dexcom G6 and YSI glucose during haemodialysis
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
  • HbA1c [ Time Frame: 28 days ]
    Glycated Haemoglobin
  • 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
  • MARD for Libre and YSI <3.9mmol/L [ Time Frame: 28 days ]
    Mean absolute relative difference between Libre and YSI glucose <3.9mmol/L
  • 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
  • MARD for Libre and YSI >10mmol/L [ Time Frame: 28 days ]
    Mean absolute relative difference between Libre and YSI glucose >10mmol/L
  • 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
  • MARD for G6 and YSI >10mmol/L [ Time Frame: 28 days ]
    Mean absolute relative difference between Dexcom G6 and YSI glucose >10mmol/L
  • 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
  • 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
  • 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
  • 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
  • CEG analysis G6 and YSI [ Time Frame: 28 DAYS ]
    Clarke Error Grid analysis between Dexcom G6 and YSI glucose during haemodialysis
  • CEG analysis Libre and YSI [ Time Frame: 28 DAYS ]
    Clarke Error Grid analysis between Libre and YSI glucose during haemodialysis
  • Severe hypoglycaemia [ Time Frame: 28 days ]
    Episodes of severe hypoglycaemia
  • DKA [ Time Frame: 28 days ]
    Diabetic Ketoacidosis
  • Sensor failure [ Time Frame: 28 days ]
    Events of G6/libre sensor failure
  • Missing glucose data [ Time Frame: 28 days ]
    Missing blood glucose data for G6/libre measured by number of missing data points
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of the Accuracy of Continuous Glucose Sensors in People With Diabetes Undergoing Haemodialysis
Official Title  ICMJE Assessment of the Accuracy of Continuous Glucose Sensors in People With Diabetes Undergoing Haemodialysis
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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
Blinded CGM but not Libre
Primary Purpose: Prevention
Condition  ICMJE
  • Diabetic Nephropathies
  • Type 1 Diabetes Mellitus
  • Chronic Kidney Diseases
Intervention  ICMJE 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
Study Arms  ICMJE 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.

Intervention: Device: Dexcom G6 and Abbott Freestyle Libre
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 20, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nick Oliver 0207 594 2460 nick.oliver@imperial.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03885362
Other Study ID Numbers  ICMJE 18SM4938
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Imperial College London
Study Sponsor  ICMJE Imperial College London
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nick Oliver Imperial College London
PRS Account Imperial College London
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP