Clinical trial NCT02703155: The Use of Home Oral Glucose Tolerance Test Kit in Screening Cystic Fibrosis Related Diabetes
Official title: The Use of Self-Administered Electronic Oral Glucose Tolerance Test Kit in Screening Cystic Fibrosis Related Diabetes in Children With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cystic Fibrosis Related Diabetes
Cystic Fibrosis
Lead sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University College, London
First posted: 2016-03-09
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The aim of this study is to establish if the self-administered electronic Oral Glucose Tolerance Test kit can increase the annual uptake of screening for CFRD in children who are between 10 and 17 years of age with CF.

Detailed description: Cystic fibrosis related diabetes (CFRD) is the most common secondary complication of Cystic fibrosis. It affects nearly 20% of adolescents and 40-50% of adults. Undiagnosed CFRD is associated with significant decline in lung function and nutritional status with an increase in mortality. This emphasises the importance of screening for CFRD in children with CF to minimise the nutritional and pulmonary consequences of diabetes.

The UK CF trust guidelines, the European consensus statement and US Cystic Fibrosis Foundation clinical care guidelines recommend the 2hr (1.75g/kg) oral glucose tolerance test as a screening tool on an annual basis in all CF patients without CFRD.

The American Diabetes Association (A.D.A) recommends that annual screening for CFRD should begin by age 10 years in all CF patients who do not have CFRD. The European Consensus Statement on this is in agreement for screening to start at age 10 years. This standard is often applied within the United Kingdom.

The current gold standard screening tool, the Oral Glucose Tolerance Test, is resource intensive. This requires an individual/child and a parent to attend a clinical facility while fasted and requires trained health care professionals to take venous samples, analyse and interpret the results.

There are also problems encountered in standardising the test. The patient should be fasted and must travel to clinic for the test in the morning. The OGTT, if done at hospital, can therefore affect an individual's time off work, time off school, can cause inconvenience and expensive for an individual, parent and child to travel to clinic. The unpredictability of workload for hospital staff means that test times are often not strictly adhered to or accurately recorded. In patients with cystic fibrosis there is also an additional risk of cross infection when they attend the hospital for OGTT. These factors limit the uptake of OGTTs for screening in children with cystic fibrosis.

To overcome these issues a simple, disposable, self-administered electronic OGTT Kit containing everything required to perform the OGTT at home with simple written and pictorial instructions has been used in this study.

The aim of this study is to establish if the self-administered electronic Oral Glucose Tolerance Test kit can increase the annual uptake of screening for CFRD in children who are between 10 and 17 years of age with CF.

Eligibility criteria: Inclusion Criteria:

* Children diagnosed with cystic fibrosis who are between 10 years and 17years old and managed at Great Ormond Street Hospital.

Exclusion Criteria:

* Children who are diagnosed with cystic fibrosis related diabetes.

Primary outcomes:
measure: proportion of annual screening for Cystic Fibrosis Related Diabetes(CFRD) in children between 10years and 17 years with Cystic Fibrosis(CF) using the Home OGTT device.
timeFrame: 1 year
Secondary outcomes:
measure: User acceptability -Questionnaire
timeFrame: 1 year
measure: Variability- timing of sample
timeFrame: 1 year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
Study officials:
affiliation: Great Ormond Street Hospital
name: Catherine Peters, FRCPCH, MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bethel MA, Price HC, Sourij H, White S, Coleman RL, Ring A, Kennedy IE, Tucker L, Holman RR. Evaluation of a self-administered oral glucose tolerance test. Diabetes Care. 2013 Jun;36(6):1483-8. doi: 10.2337/dc12-0643. Epub 2013 Jan 15.
citation: Moran A, Brunzell C, Cohen RC, Katz M, Marshall BC, Onady G, Robinson KA, Sabadosa KA, Stecenko A, Slovis B; CFRD Guidelines Committee. Clinical care guidelines for cystic fibrosis-related diabetes: a position statement of the American Diabetes Association and a clinical practice guideline of the Cystic Fibrosis Foundation, endorsed by the Pediatric Endocrine Society. Diabetes Care. 2010 Dec;33(12):2697-708. doi: 10.2337/dc10-1768. No abstract available.
citation: Wickens-Mitchell KL, Gilchrist FJ, McKenna D, Raffeeq P, Lenney W. The screening and diagnosis of cystic fibrosis-related diabetes in the United Kingdom. J Cyst Fibros. 2014 Sep;13(5):589-92. doi: 10.1016/j.jcf.2014.01.008. Epub 2014 Feb 14.
citation: Management of cystic fibrosis related diabetes mellitus. Report of the UK Cystic Fibrosis Trust Diabetes Working Group; 2004 [June, n.d.].
citation: Ode KL, Moran A. New insights into cystic fibrosis-related diabetes in children. Lancet Diabetes Endocrinol. 2013 Sep;1(1):52-8. doi: 10.1016/S2213-8587(13)70015-9. Epub 2013 May 23.
citation: Kern AS, Prestridge AL. Improving screening for cystic fibrosis-related diabetes at a pediatric cystic fibrosis program. Pediatrics. 2013 Aug;132(2):e512-8. doi: 10.1542/peds.2012-4029. Epub 2013 Jul 1.