Type 2 diabetes mellitus (T2DM) Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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%
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in HbA1c at 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom