Type 2 diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosed with T2D 2. Aged =18 years 3. Mild/moderate ID as confirmed by health professional/medical records 4. Sufficient communication skills to engage in a group education programme 5. Able to give informed consent 6. Living in the community
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes 2. Severe/profound ID 3. Displaying severe challenging behaviour 4. Acute psychotic illness 5. Lack mental capacity to give consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline to 6 months post-randomisation measured using blood test | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in HbA1c from baseline at 12 months (all participants) and 18 months (Internal Pilot participants only) measured using blood test At 6 and 12 months (all participants), and at 18 months (Internal Pilot participants only): 2. Metabolic and cardiovascular measures: Lipids (Total cholesterol, Low-density lipoprotein (LDL) cholesterol, High-density lipoprotein (HDL) cholesterol), estimated Glomerular Filtration Rate (eGFR), Diastolic and systolic blood pressure (mmHg); Weight (kg); Body Mass Index (kg/m²) 3. Illness perception measured using the Illness Perception Questionnaire Revised (IPQ) 4. Depression measured using the Glasgow Depression Scale 5. Health-related quality of life measured using EQ-5D 6. Health and social care service use and associated costs measured using ModRUM (Modular Resource Use Measure) 7. Intervention costs measured using ModRUM | — |
Countries
England, Northern Ireland, Scotland, United Kingdom