Comparing Laboratory Blood Glucose Results With HemoCue Glucose 201 RT

NCT01883037 | Completed DMC

• 1 other identifier: 2012CF007B
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Cystic Fibrosis

Keywords

Cystic Fibrosis; Cystic Fibrosis related diabetes; Oral glucose tolerance test

Outcome Measures

Primary Outcomes (1)

• Does HemoCue Glucose 201 RT provide lab-quality results in the analysis of glucose values during oral glucose tolerance tests?

  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 Outcomes (1)

• Is HemoCue Glucose 201 RT method cost saving relative to the traditional laboratory method for analysing glucose values taken during oral glucose tolerance tests?

  One year

Other Outcomes (1)

• 2. To see if the HemoCue Glucose 201 RT offers sufficient advantages to make it a viable alternative to conventional testing

  One year

Study Arms (2)

Laboratory blood glucose

Blood glucose value from Lab

Other: Blood glucose results

HemoCue Glucose 201 RT

Blood glucose value from HemoCue Glucose 201 RT

Other: Blood glucose results

Interventions

Blood glucose results OTHER

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

Also known as: HemoCue Glucose 201 RT

HemoCue Glucose 201 RT; Laboratory blood glucose

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients with an existing diagnosis of CFRD are exclude.

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Blood Glucose

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Glucose; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Nicholas J Simmonds, MD MRCP

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: June 21, 2013
• Study Start: June 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: November 13, 2014

Record last verified: 2014-11

Locations

GB (1)