Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/03/2010
Date assigned
25/03/2010
Last edited
01/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Eric Kilpatrick

ORCID ID

Contact details

220-236 Anlaby Road
Hull
HU3 2RW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

A Longitudinal Study on the Effect of Flooding on the Glycaemic Control of Patients with Diabetes Mellitus

Acronym

Study hypothesis

A natural disaster such floods has a detrimental effect on glycaemic control in patients with diabetes mellitus.

Ethics approval

Hull and East Riding Local Research Ethics Committee approved (LRED: 08/H1304/83)

Study design

Longitudinal study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

Diabetes Mellitus (type I and II)

Intervention

Data were collected using anonymous numbers assigned to each recipient and then scanned the data using a computer software called FORMIC

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

We 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 measures

To 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 trial start date

20/12/2008

Overall trial end date

30/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. All patients registered as having diabetes mellitus via pathology database
2. Age ≥ 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

15,000

Participant exclusion criteria

1. Nursing home patients
2. Prisoners
3. Patients dependent on professional care for management of their diabetes.

Recruitment start date

20/12/2008

Recruitment end date

30/03/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

220-236 Anlaby Road
Hull
HU3 2RW
United Kingdom

Sponsor information

Organisation

Hull & East Yorkshire Hospitals NHS Trust (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Diabetes UK (UK) (ref: 08/0003768)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21214625

Publication citations

  1. Results

    Ng J, Atkin SL, Rigby AS, Walton C, Kilpatrick ES, The effect of extensive flooding in Hull on the glycaemic control of patients with diabetes., Diabet. Med., 2011, 28, 5, 519-524, doi: 10.1111/j.1464-5491.2011.03228.x.

Additional files

Editorial Notes