Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Melanie Davies


Contact details

Leicester Diabetes Centre (Broadleaf)
Leicester General Hospital
Gwendolen road
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number

UNOLE 0106

Study information

Scientific title

To test an integrated approach for promoting effective self management in people with established Type 2 Diabetes Mellitus (T2DM): a cluster randomised controlled trial of the DESMOND Ongoing education programme


Study hypothesis

An approach integrating ongoing self-management education with clinical management in those with established Type 2 Diabetes Mellitus (T2DM) within a primary care setting will improve glycaemic control, other biomedical parameters and patient level outcomes

Ethics approval

Leicestershire Northampton and Rutland Committee 1, 07/09/2010, ref:10/H0406/54

Study design

Multicentre cluster randomised controlled trial with randomisation at the level of the GP Practice

Primary study design


Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type


Patient information sheet

Not available in web format. Please use contact details below to request a patient information leaflet


Type 2 diabetes mellitus (T2DM)


Patients in the intervention group will receive the following:
1. DESMOND Foundation. An existing DESMOND 6-hour group education course which provides introductory information for managing type-2 diabetes
2. Six group sessions of DESMOND-Ongoing (4 in the 1st year and 2 in the 2nd year) delivered by specially trained DESMOND Educators which concentrate on developing self-management skills in people with established type-2 diabetes and covers specific topics related to type-2 diabetes including diet, exercise, managing hypo- and hyper-glycaemia
3. Two Care Planning sessions (delivered at yearly intervals) delivered at the level of the GP Practice by trained GPs and/or Practice Nurses. Care Planning focuses on 'looking with rather than at' someone with diabetes to plan their care and areas for improvement over the forthcoming year. Patients are helped to identify goals and make action plans to acheive these. The healthcare professionals delivering the Care Planning sessions will first be given in-depth training in Care Planning by DESMOND Eductors within the study group.

The intervention is a rolling intervention. In the ‘real world’ it will comprise a six hour introductory session (DESMOND Foundation), a Care Planning session, and then four rolling sessions of DESMOND ongoing delivered at 6 monthly intervals (meaning that the complete material is delivered in 2 years. However, for the trial we are condensing the intervention during the first years as a proof of concept and then will change to the frequency that it would be delivered in the ‘real world’ during the 2nd year. Therefore intervention patients will receive the six sessions mentioned above during the first year and then a further Care Planning session and 2 sessions of Going Forward with Diabetes during the 2nd year.

Intervention type



Drug names

Primary outcome measure

Reduction in HbA1c at 24 months

Secondary outcome measures

1. Reduction in the following biomedical measures measured at 12 and 24 months
1.1. HbA1c (at 12 months)
1.2. Cholesterol (total, HDL and LDL)
1.3. Triglyceride
1.4. Blood pressure (BP) Systolic
1.5. BP Diastolic
1.6. Weight
1.7. Waist circumference
1.8. Hip circumference

2. Improvement in the following scores at 12 and 24 months
2.1. EQ5D
2.2. Illness Perceptions Questionnaire revised
2.3. Diabetes Illness Representations Questionnaire
2.4. Summary of Diabetes Self Care Activities questionnaire
2.5. Hospital Anxiety and Depression Score
2.6. Problem Areas in Diabetes Score
2.7. International Physical Activity Questionnaire

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Current participant inclusion criteria as of 04/02/2019:
1. Individuals with established Type 2 Diabetes Mellitus
2. Diabetes duration of 12 months or more
3. HbA1c between 7.8 and 11%

Previous participant inclusion criteria:
1. Individuals with established Type 2 Diabetes Mellitus
2. Diabetes duration of 12 months or more
3. HbA1c between 7.0 and 11%

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Receiving insulin therapy
2. Have existing comorbidities that could interfere with participation in the study over the 24 months
3. Unable to give informed consent
4. Severe and enduring mental health problems
5. Patients who are not primarily responsible for their own care
6. Unable to participate in a group programme (e.g. housebound)
7. Insufficient understanding of English to participate in the group education
8. Visually impaired or hard of hearing to the level that they can not participate in the group education
9. Aged under 18 years

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Leicester Diabetes Centre (Broadleaf)
United Kingdom

Sponsor information


University of Leicester (UK)

Sponsor details

University Road
United Kingdom
+44 (0)11 6252 2759

Sponsor type




Funder type


Funder name

National Institute for Health Research (NIHR) (UK) - Collaboration for Leadership in Applied Health Research and Care (CLAHRC)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Leicestershire, Northamptonshire and Rutland CLARHC and CLAHRC for South Yorkshire (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

See additional file (ISRCTN71467886_BasicResults_4Feb19.pdf)

Publication list

Publication citations

Additional files

Editorial Notes

04/02/2019: The following changes were made: 1. The basic results of this trial were uploaded as an additional file. 2. The participant inclusion criteria was updated. 27/04/2018: No publications found, verifying study status with principal investigator 03/03/2016: No publications found, verifying study status with principal investigator