MedTrace Logo

Comparing Laboratory Blood Glucose Results With HemoCue Glucose 201 RT

NCT01883037 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2014-11-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Blood glucose results

The glucose value from the HemoCue Glucose 201 RT will be compared with the Trust Laboratory value.

Sponsors & Collaborators

  • Royal Brompton & Harefield NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Nicholas J Simmonds, MD MRCP · Royal Brompton & Harefield NHS Foundation Trust

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-04-30
Completion
2014-05-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01883037 on ClinicalTrials.gov