Comparing Laboratory Blood Glucose Results With HemoCue Glucose 201 RT
NCT ID: NCT01883037
Last Updated: 2014-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
70 participants
OBSERVATIONAL
2013-06-30
2014-05-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Laboratory blood glucose
Blood glucose value from Lab
Blood glucose results
The glucose value from the HemoCue Glucose 201 RT will be compared with the Trust Laboratory value.
HemoCue Glucose 201 RT
Blood glucose value from HemoCue Glucose 201 RT
Blood glucose results
The glucose value from the HemoCue Glucose 201 RT will be compared with the Trust Laboratory value.
Interventions
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Blood glucose results
The glucose value from the HemoCue Glucose 201 RT will be compared with the Trust Laboratory value.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
16 Years
ALL
No
Sponsors
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Royal Brompton & Harefield NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Nicholas J Simmonds, MD MRCP
Role: PRINCIPAL_INVESTIGATOR
Royal Brompton & Harefield NHS Foundation Trust
Locations
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Royal Brompton Hospital
London, , United Kingdom
Countries
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Other Identifiers
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2012CF007B
Identifier Type: -
Identifier Source: org_study_id