Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/04/2007
Date assigned
16/05/2007
Last edited
30/07/2012
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 Melanie Davies

ORCID ID

Contact details

Leicester Diabetes Centre (Broadleaf)
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

DESMOND

Study hypothesis

To evaluate the effectiveness and feasibility of delivering structured group self-management education to individuals newly diagnosed with type two diabetes.

Ethics approval

Approval received from Multi-centre Research Ethics Committee (MREC) on the 16th June 2004.

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Self management of type two diabetes

Intervention

A programme of six hours of structured group education consisting of two three-hour sessions offered as either one day or two half-days, facilitated by two health care professionals trained to deliver the intervention to groups of up to ten people newly diagnosed with type two diabetes, who may be accompanied by a partner, family member or friend.

This is compared to a control group receiving enhanced routine care.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Glycaemic control as measured by HbA1c at 12 months.

Secondary outcome measures

1. Cardiovascular (CV) risk as measured by lipid profile and blood pressure
2. Quality of life indicators, diabetes control, self-care and illness belief perceptions of patients at 12 months

Overall trial start date

01/07/2004

Overall trial end date

31/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Greater than 18 years of age
2. Referred to the study within four weeks of diagnosis of type two diabetes
3. In intervention group, able to attend the intervention within 12 weeks of diagnosis

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

1,000

Participant exclusion criteria

1. Are unable to give informed consent
2. Have been recruited to take part, or are already taking part in other research
3. Have severe and enduring mental health problems
4. Are not primarily responsible for their own care
5. Are unable to participate in a group programme
6. Have insufficient understanding of English to participate in the group education

Recruitment start date

01/07/2004

Recruitment end date

31/01/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leicester Diabetes Centre (Broadleaf)
Leicester
LE5 4PW
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust (UK)

Sponsor details

Gwendolen House
Gwendolen Road
Leicester
LE5 4PW
United Kingdom

Sponsor type

Government

Website

http://www.uhl-tr.nhs.uk/

Funders

Funder type

Industry

Funder name

Diabetes UK (UK) (ref: BDA:RD04/0002922)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Department of Health (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NovoNordisk (UK) - unrestricted educational grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18276664
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22539172

Publication citations

  1. Results

    Davies MJ, Heller S, Skinner TC, Campbell MJ, Carey ME, Cradock S, Dallosso HM, Daly H, Doherty Y, Eaton S, Fox C, Oliver L, Rantell K, Rayman G, Khunti K, , Effectiveness of the diabetes education and self management for ongoing and newly diagnosed (DESMOND) programme for people with newly diagnosed type 2 diabetes: cluster randomised controlled trial., BMJ, 2008, 336, 7642, 491-495, doi: 10.1136/bmj.39474.922025.BE.

  2. Results

    Khunti K, Gray LJ, Skinner T, Carey ME, Realf K, Dallosso H, Fisher H, Campbell M, Heller S, Davies MJ, Effectiveness of a diabetes education and self management programme (DESMOND) for people with newly diagnosed type 2 diabetes mellitus: three year follow-up of a cluster randomised controlled trial in primary care., BMJ, 2012, 344, e2333.

Additional files

Editorial Notes