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Diabetes 6 (D-6) trial: psychologically enhanced diabetes care, delivered by nurses

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN75776892
Enrollment
432
Registered
2010-05-19
Start date
2010-09-27
Completion date
Unknown
Last updated
2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Diabetes Research Network

Interventions

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 psychologica

Sponsors

King's College Hospital NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Change in HbA1c (glycaemic control) at 18 months

Secondary

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 24, 2026