Effect of Flooding on the Glycaemic Control of Patients with Diabetes Mellitus
| ISRCTN | ISRCTN54232449 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54232449 |
| Protocol serial number | 1 |
| Sponsor | Hull & East Yorkshire Hospitals NHS Trust (UK) |
| Funder | Diabetes UK (UK) (ref: 08/0003768) |
- 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
Scientific
220-236 Anlaby Road
Hull
HU3 2RW
United Kingdom
Study information
| Primary study design | Observational |
|---|---|
| Study design | Longitudinal study |
| Secondary study design | Cohort study |
| Scientific title | A Longitudinal Study on the Effect of Flooding on the Glycaemic Control of Patients with Diabetes Mellitus |
| Study objectives | A 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) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 30/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 15000 |
| Key inclusion criteria | 1. All patients registered as having diabetes mellitus via pathology database 2. Age ≥ 18 years |
| Key exclusion criteria | 1. Nursing home patients 2. Prisoners 3. Patients dependent on professional care for management of their diabetes. |
| Date of first enrolment | 20/12/2008 |
| Date of final enrolment | 30/03/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
220-236 Anlaby Road
Hull
HU3 2RW
United Kingdom
HU3 2RW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
