Comparing Laboratory Blood Glucose Results With HemoCue Glucose 201 RT (CFRD)

November 12, 2014 updated by: Royal Brompton & Harefield NHS Foundation Trust

To Compare the Clinical Accuracy of Glucose Measurement During Oral Glucose Tolerance Test Using Two Methods: i) Laboratory Standard Technique, ii) HemoCue Glucose 201 RT System

There are very few studies comparing the accuracy, sensitivity and specificity of HemoCue glucose 201 RT system with the laboratory gold standard.

The incidence of cystic fibrosis related diabetes (CFRD) has risen significantly as patients' survival improves. Around 30% of all cystic fibrosis (CF) adult patients have CFRD. Early diagnosis of CFRD is important to slow the deterioration of lung function and nutritional status, both of which increase mortality.

The oral glucose tolerance test (OGTT) is the accepted method for detecting CFRD and the Cystic Fibrosis Trust guidelines recommend that patients with CF over the age of twelve years should be screened annually.

The World Health Organisation has pointed out that due to the absence of a more specific biological marker to define diabetes, plasma glucose estimation remains the basis of diagnostic criteria. WHO recommends that venous plasma glucose should be the standard method for measuring and reporting glucose concentration in blood. However, it has also recognised that there is a widespread use of capillary sampling. Although fasting values for venous and capillary plasma glucose are the same, in the nonfasting state capillary samples will give higher results than venous samples, and glucose values require conversion which can be problematic.

HemoCue Glucose 201 RT (HGS 201 RT) analyzer with plasma conversion provides laboratory quality test results at the point of care for the diagnosis, screening and monitoring of diabetes mellitus. The analyzer is easy to use and the system can be operated by nonlaboratory personnel, also the results can be presented immediately, leading to significant time and resource saving. The patient also benefits from having the result immediately instead of waiting for several hours. With immediate result, the doctor and health care professionals can provide education, support and reassurance, and implement care plans, if appropriate, at the earliest opportunity.

The aim of the study is to compare the clinical accuracy of HemoCue Glucose 201 RT with the laboratory standard method in the analysis of blood glucose concentration during oral glucose tolerance test.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All CF patients attending annual review who require an OGTT will have a venous and a capillary blood sample taken simultaneously before (fasting = 0 min) and 2 hours (post glucose load = 120 min) after the administration of 75 grams Glucose solution orally.

The capillary sample will be analysed immediately using HGS 201 RT. The venous sample will be collected in a Fluoride Oxalate tube (WHO guideline) and sent to the Trust's laboratory for analysis as per usual practice.

Study Type

Observational

Enrollment (Actual)

70

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, SW3 6NP
        • Royal Brompton Hospital

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The first 70 consecutive adult CF patients, without cystic fibrosis related diabetes, who are 16 years of age and over, attending annual review at the Royal Brompton Hospital from June 2013, are eligible for the study.

Description

Inclusion Criteria:

The first 70 consecutive suitable consenting adult CF patients, who are 16 years of age and over, attending annual review at the Royal Brompton Hospital from June 2013 to March 2014, are eligible for the study

Exclusion Criteria:

Patients with an existing diagnosis of CFRD are exclude.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Laboratory blood glucose
Blood glucose value from Lab
Other: Blood glucose results
The glucose value from the HemoCue Glucose 201 RT will be compared with the Trust Laboratory value.
Other Names:
  • HemoCue Glucose 201 RT
HemoCue Glucose 201 RT
Blood glucose value from HemoCue Glucose 201 RT
Other: Blood glucose results
The glucose value from the HemoCue Glucose 201 RT will be compared with the Trust Laboratory value.
Other Names:
  • HemoCue Glucose 201 RT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Does HemoCue Glucose 201 RT provide lab-quality results in the analysis of glucose values during oral glucose tolerance tests?
Time Frame: One year
The glucose value from the HemoCue Glucose 201 RT will be compared with the Trust Laboratory value. The sensitivity, specificity and clinical significance will be calculated.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Is HemoCue Glucose 201 RT method cost saving relative to the traditional laboratory method for analysing glucose values taken during oral glucose tolerance tests?
Time Frame: One year
The cost of using the HemoCue Glucose 201 RT will be compared with Trust Laboratory cost for analysing the glucose value from OGTT.
One year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
2. To see if the HemoCue Glucose 201 RT offers sufficient advantages to make it a viable alternative to conventional testing
Time Frame: One year
If using HemoCue Glucose 201 RT is shown to offer cost and clinical advantages over conventional testing then look to implement as standard test method and report more widely.
One year

Collaborators and Investigators

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

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Investigators

  • Principal Investigator: Nicholas J Simmonds, MD MRCP, Royal Brompton & Harefield NHS Foundation Trust

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

June 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

June 13, 2013

First Submitted That Met QC Criteria

June 18, 2013

First Posted (Estimate)

June 21, 2013

Study Record Updates

Last Update Posted (Estimate)

November 13, 2014

Last Update Submitted That Met QC Criteria

November 12, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012CF007B

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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