NCT02703155

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

March 9, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

February 9, 2016

Last Update Submit

March 3, 2016

Conditions

Cystic Fibrosis Related DiabetesCystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • 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.

    Proportion of annual screening for Cystic Fibrosis Related Diabetes(CFRD) in children between 10years and 17 years with Cystic Fibrosis(CF).

    1 year

Secondary Outcomes (2)

  • User acceptability -Questionnaire

    1 year

  • Variability- timing of sample

    1 year

Study Arms (1)

Home Oral Glucose tolerance test kit

OTHER

Providing children with Cystic Fibrosis between 10 and 17 years of age with Home Oral glucose tolerance test kit to screen Cystic fibrosis related Diabetes.

Device: Home Oral Glucose Tolerance Test kit

Interventions

Home Oral Glucose Tolerance Test kitDEVICE

Providing Home Oral glucose tolerance test kit to children with Cystic fibrosis for screening Cystic Fibrosis Related Diabetes

Home Oral Glucose tolerance test kit

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Children who are diagnosed with cystic fibrosis related diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Great Ormond Street Hospital

London, London, United Kingdom

RECRUITING

Related Publications (6)

  • 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.

    PMID: 23321216BACKGROUND

  • 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.

    PMID: 21115772BACKGROUND

  • 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.

    PMID: 24529737BACKGROUND

  • Management of cystic fibrosis related diabetes mellitus. Report of the UK Cystic Fibrosis Trust Diabetes Working Group; 2004 [June, n.d.].

    BACKGROUND

  • 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.

    PMID: 24622267BACKGROUND

  • 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.

    PMID: 23821699BACKGROUND

Related Links

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Catherine Peters, FRCPCH, MD.

    Great Ormond Street Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Peters, FRCPCH, MD.

CONTACT

02078138247catherine.peters@gosh.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2016

First Posted

March 9, 2016

Study Start

October 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

March 9, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)