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
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
-
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.