DESMOND (Diabetes Education and Self Management for Ongoing and Newly Diagnosed): a randomised controlled trial of a structured group education programme for people newly diagnosed with type two diabetes

ISRCTN	ISRCTN17844016
DOI	https://doi.org/10.1186/ISRCTN17844016
Protocol serial number	N/A
Sponsor	University Hospitals of Leicester NHS Trust (UK)
Funders	Diabetes UK (UK) (ref: BDA:RD04/0002922), Department of Health (UK), NovoNordisk (UK) - unrestricted educational grant

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Melanie Davies
Scientific

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

Primary study design	Interventional
Study design	Cluster randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	DESMOND
Study objectives	To evaluate the effectiveness and feasibility of delivering structured group self-management education to individuals newly diagnosed with type two diabetes.
Ethics approval(s)	Approval received from Multi-centre Research Ethics Committee (MREC) on the 16th June 2004.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Glycaemic control as measured by HbA1c at 12 months.
Key secondary outcome measure(s)	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
Completion date	31/01/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	1000
Key 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
Key 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
Date of first enrolment	01/07/2004
Date of final enrolment	31/01/2007

Leicester Diabetes Centre (Broadleaf)

Leicester
LE5 4PW
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2008		Yes	No
Results article	results	26/04/2012		Yes	No