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

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Kirsty Winkley


Contact details

Department of Psychological Medicine
Weston Education Centre
10 Cutcombe Road
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A randomised controlled trial of 'Psychologically Enhanced Diabetes Care, delivered by nurses' (D-6) for people with Type 2 diabetes and sub-optimal glycaemic control



Study hypothesis

Some people with type 2 diabetes (T2DM) have problems reaching ideal blood glucose levels that will prevent a worsening of their condition. They may need to make significant lifestyle changes to do this which can be very difficult. Often it may be a question of being unsure whether they can make the changes not that they don't know what changes to make. Talking therapies such as motivational interviewing and cognitive behavioural therapy can help people talk through their difficulties within a supportive relationship and help foster their own self confidence in their ability to make changes. These therapies have increasingly been used in health settings although usually delivered by psychologists but the skills involved can be taught to non-psychologists such as practice nurses.

The aim of this study is to train practice nurses (for intervention GP practices) in talking therapy for diabetes and compare their patients with those from practices where nurses have not had the training. We would invite approximately 24 GP practices from the London boroughs of Lambeth, Southwark and Lewisham to participate and these would be randomised and nurses in the intervention practices would receive training. Nurses working in the non-intervention (control) GP practices would receive additional training in diabetes education. If this study shows that training nurses in talking therapy helps their patients to get better control of their diabetes this training could be offered to other practice nurses working in the NHS.

Ethics approval

1. South East Ethics Committee 3, 30/11/2009, ref: 09/H0808/97
2. Research & Development Centre for South East London NHS, 05/05/2010, ref: RDLSL 534/CSP 20423

Study design

Multicentre randomised interventional treatment trial

Primary study design


Secondary study design

Randomised controlled 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 sheet


Topic: Diabetes Research Network; Subtopic: Type 2; Disease: Hypertension, Dyslipidaemia, Diabetic Control, Obesity, Prevention/screening


Baseline blood tests are taken in both the treatment and control groups. Patients are randomised to:
1. D-6 treatment group: face to face psychological diabetes care sessions. Maintenance psychological diabetes sessions, specified by patient, may be telephone/e-mail/face to face.
2. Control group: Face to face diabetes education sessions. Maintenance education sessions specified by patient, may be telephone/e-mail/face to face.

Follow-up blood tests are then taken in both the treatment and control groups.

Total duration of intervention: 12 months
Total duration of follow-up: 6 months

Intervention type



Phase II

Drug names

Primary outcome measure

Change in HbA1c (glycaemic control) at 18 months

Secondary outcome measures

1. Total cholesterol, taken at baseline and at end of study
2. Blood pressure, taken at baseline and at end of study
3. BMI, taken at baseline and at end of study
4. Quality of life, measured before and after intervention
5. Depressive symptoms, measured before and after intervention
6. Economic evaluation, measured before and after intervention

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. People with Type 2 diabetes for more than 2 years
2. Resident in south London boroughs of Lambeth Southwark and Lewisham
3. Aged 18 - 79 years, either sex
4. Persistent suboptimal glycaemic control defined as HbA1c above or equal to 8% on occasions in the past 12 months despite 2 appointments with a diabetes health professional

Participant type


Age group




Target number of participants

Planned sample size: 432

Participant exclusion criteria

1. Severe mental disorders
2. Terminal illnesses and severe end stage diabetes complications
3. Morbid obesity with a body mass index (BMI) greater than 50 kg/m^2 as there is usually comorbid psychiatric morbidity
4. No telephone or mobile phone access as telephone contact is part of the intervention

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Department of Psychological Medicine
United Kingdom

Sponsor information


King's College Hospital NHS Foundation Trust (UK)

Sponsor details

Department of Research & Development
34 Love Walk
United Kingdom

Sponsor type




Funder type


Funder name

National Institute for Health Research (NIHR) (UK) - Programme Grants for Applied Research (ref: RP-PG-0606-1142)

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)

Publication list

2016 results in:

Publication citations

Additional files

Editorial Notes

14/06/2017: The overall trial dates have been updated from 04/04/2008 - 01/04/2010 to 15/10/2007 - 30/11/2016 and the recruitment dates have been updated from 04/04/2008 - 01/04/2010 to 27/09/2010 - 11/10/2011. 22/08/2016: Publication reference added