Effect of Flooding on the Glycaemic Control of Patients with Diabetes Mellitus

ISRCTN ISRCTN54232449
DOI https://doi.org/10.1186/ISRCTN54232449
Secondary identifying numbers 1
Submission date
18/03/2010
Registration date
25/03/2010
Last edited
01/08/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Eric Kilpatrick
Scientific

220-236 Anlaby Road
Hull
HU3 2RW
United Kingdom

Study information

Study designLongitudinal study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Other
Study typeOther
Scientific titleA Longitudinal Study on the Effect of Flooding on the Glycaemic Control of Patients with Diabetes Mellitus
Study objectivesA natural disaster such floods has a detrimental effect on glycaemic control in patients with diabetes mellitus.
Ethics approval(s)Hull and East Riding Local Research Ethics Committee approved (LRED: 08/H1304/83)
Health condition(s) or problem(s) studiedDiabetes Mellitus (type I and II)
InterventionData were collected using anonymous numbers assigned to each recipient and then scanned the data using a computer software called FORMIC
Intervention typeOther
Primary outcome measureWe intend to determine if glycaemic control (as assessed by HbA1c) was different amongst patients with diabetes who were flooded compared to those who were not. The analysis, to be performed by a statistician will most likely use an unpaired t test analysis following logarithmic transformation of the HbA1c data.
Secondary outcome measuresTo establish if the frequency of HbA1c monitoring was different amongst those flooded compared to those who were not over the 15 months following the flooding.
Overall study start date20/12/2008
Completion date30/03/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants15,000
Key inclusion criteria1. All patients registered as having diabetes mellitus via pathology database
2. Age ≥ 18 years
Key exclusion criteria1. Nursing home patients
2. Prisoners
3. Patients dependent on professional care for management of their diabetes.
Date of first enrolment20/12/2008
Date of final enrolment30/03/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

220-236 Anlaby Road
Hull
HU3 2RW
United Kingdom

Sponsor information

Hull & East Yorkshire Hospitals NHS Trust (UK)
Hospital/treatment centre

c/o James Illingsworth
R&D Department
Office 6
2nd Floor Daisy Building
Castle Hill Hospital
Castle Road
Cottingham
HU16 5JQ
England
United Kingdom

ROR logo "ROR" https://ror.org/01b11x021

Funders

Funder type

Charity

Diabetes UK (UK) (ref: 08/0003768)
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
DIABETES UK LIMITED, British Diabetic Association
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2011 Yes No