DESMOND (Diabetes Education and Self Management for Ongoing and Newly Diagnosed) Monitoring Study
| ISRCTN | ISRCTN95696668 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95696668 |
| Secondary identifying numbers | 1 |
- Submission date
- 24/12/2009
- Registration date
- 18/05/2010
- Last edited
- 27/10/2022
- 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
Not provided at time of registration
Contact information
Prof Simon Heller
Scientific
Scientific
Professor of Clinical Diabetes
AUDEM Room OU141
University of Sheffield Medical School
Beech Hill Road
Sheffield
S10 2RX
United Kingdom
| s.heller@sheffield.ac.uk |
Study information
| Study design | Multicentre cluster randomised controlled trial with randomisation at practice level |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Other |
| Participant information sheet | Not available in web format. Please use contact details below to request a patient information sheet |
| Scientific title | Does self-monitoring of blood glucose as opposed to urinalysis provide additional benefit to newly diagnosed individuals with Type 2 diabetes receiving structured education? |
| Study hypothesis | To compare the effectiveness of urine and blood glucose monitoring strategies, when taught as part of a structured education programme, on glycaemic control in patients newly diagnosed with Type 2 diabetes. The measure of glycaemic control will be level of HbA1c in the blood 18 months after attending the programme. Please note, as of 03/11/2011 the anticipated start and end dates have been updated. The previous dates were as follows: Original start date: 01/12/2009 Original end date: 01/03/2010 |
| Ethics approval(s) | Cambridgeshire 1 Research Ethics Committee approved on the 6th February 2008 (ref: 07/H0304/129) |
| Condition | Type 2 diabetes (newly diagnosed) |
| Intervention | DESMOND structured group education programme. This is a 7 hour programme (two sessions of 3.5 hours each) which includes a session on self monitoring (blood or urine depending on randomisation of people attending) |
| Intervention type | Other |
| Primary outcome measure | HbA1c measured at 18 month follow-up |
| Secondary outcome measures | 1. Blood cholesterol 2. Body weight 3. Blood pressure 4. Waist circumference 5. Lifestyle (smoking and physical activity) 6. Questionnaire tools listed below 6.1. Diabetes Treatment Satisfaction Questionnaire 6.2. Well Being Questionnaire - 28 6.3. EQ-5D 6.4. Confidence in Self Care (CIDS) 6.5. Brief Diabetes Perceptions Questionnaire 6.6. Short Form 36 questionnaire 6.7. Summary of Diabetes Self Care Activities |
| Overall study start date | 28/09/2008 |
| Overall study end date | 21/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 400 |
| Total final enrolment | 292 |
| Participant inclusion criteria | 1. Age over 18 years 2. Newly diagnosed and able to attend a DESMOND course within 12 weeks of diagnosis 3. Capable of giving informed consent 4. Primarily responsible for their own care 5. Able to participate in a group programme 6. Can understand both written and spoken English |
| Participant exclusion criteria | 1. Severe medical problems (eg severe heart failure, advanced cancer) that would result in the patient gaining no benefit from attending an education programme. This will be at the discretion of the general practitioner. 2. Taking part in another research study |
| Recruitment start date | 28/09/2008 |
| Recruitment end date | 21/12/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Professor of Clinical Diabetes
Sheffield
S10 2RX
United Kingdom
S10 2RX
United Kingdom
Sponsor information
University Hospitals of Leicester (UK)
University/education
University/education
Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom
| carolyn.maloney@uhl-tr.nhs.uk | |
| Website | http://www.uhl-tr.nhs.uk/ |
"ROR" |
https://ror.org/02fha3693 |
Funders
Funder type
Charity
Diabetes UK (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 14/03/2012 | Yes | No | |
| Other publications | educators' views | 09/01/2014 | Yes | No | |
| Results article | 01/03/2015 | 27/10/2022 | Yes | No |
Editorial Notes
27/10/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
