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

August 4, 2022 updated by: Imperial College London
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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, the investigators 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

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Imperial College London/NHS trust Renal Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MARD between G6 and YSI
Time Frame: 28 days
Mean absolute relative difference between Dexcom G6 and YSI glucose during haemodialysis
28 days
MARD between Libre and YSI
Time Frame: 28 days
Mean absolute relative difference between Dexcom G6 and YSI glucose during haemodialysis
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 28 days
Glycated Haemoglobin
28 days
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
28 days
MARD for Libre and YSI <3.9mmol/L
Time Frame: 28 days
Mean absolute relative difference between Libre and YSI glucose <3.9mmol/L
28 days
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
28 days
MARD for Libre and YSI >10mmol/L
Time Frame: 28 days
Mean absolute relative difference between Libre and YSI glucose >10mmol/L
28 days
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
28 days
MARD for G6 and YSI >10mmol/L
Time Frame: 28 days
Mean absolute relative difference between Dexcom G6 and YSI glucose >10mmol/L
28 days
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
24 hours
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
24 hours
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
24 hours
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
24 hours
CEG analysis G6 and YSI
Time Frame: 28 DAYS
Clarke Error Grid analysis between Dexcom G6 and YSI glucose during haemodialysis
28 DAYS
CEG analysis Libre and YSI
Time Frame: 28 DAYS
Clarke Error Grid analysis between Libre and YSI glucose during haemodialysis
28 DAYS
Severe hypoglycaemia
Time Frame: 28 days
Episodes of severe hypoglycaemia
28 days
DKA
Time Frame: 28 days
Diabetic Ketoacidosis
28 days
Sensor failure
Time Frame: 28 days
Events of G6/libre sensor failure
28 days
Missing glucose data
Time Frame: 28 days
Missing blood glucose data for G6/libre measured by number of missing data points
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2019

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

February 22, 2019

First Submitted That Met QC Criteria

March 20, 2019

First Posted (Actual)

March 21, 2019

Study Record Updates

Last Update Posted (Actual)

August 5, 2022

Last Update Submitted That Met QC Criteria

August 4, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18SM4938

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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