Improving diabetes self-management for people with severe mental illness

Evaluating a diabetes self-management intervention for people with severe mental illness: the DIAMONDS programme (Diabetes and Mental Illness, Improving Outcomes and Self-management)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN22275538

Enrollment

380

Registered

2022-10-07

Start date

2022-12-20

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Diabetes self-management for people with severe mental illness Nutritional, Metabolic, Endocrine Diabetes mellitus

Interventions

Current interventions as of 05/04/2024: The DIAMONDS RCT is a multi-centre, two-armed, parallel, individually randomised control trial with embedded process and economic evaluations. The trial include

Eligibility

Sex/Gender

All

Age

18 Years to 110 Years

Inclusion criteria

Inclusion criteria: Current participant inclusion criteria as of 25/10/2024: 1. Adults (aged 18 years or older) 2. Confirmed diagnosis of severe mental illness (SMI; schizophrenia, bipolar disorder, schizoaffective disorder, psychosis, severe depression) and type 2 diabetes Previous participant inclusion criteria: 1. Adults (aged 18 years or older) 2. Confirmed diagnosis of severe mental illness (SMI; schizophrenia, bipolar disorder, schizoaffective disorder, severe depression) and type 2 diabetes

Exclusion criteria

Exclusion criteria: Current participant exclusion criteria as of 25/10/2024: 1. Cognitive impairments 2. Gestational diabetes, type 1 diabetes, diabetes due to a specific genetic defect or secondary to pancreatitis or endocrine conditions 3. Impaired capacity to participate 4. Current inpatient in an acute or mental health hospital Previous participant exclusion criteria: 1. Cognitive impairments 2. Gestational diabetes, type 1 diabetes, diabetes due to a specific genetic defect or secondary to pancreatitis or endocrine conditions 3. Impaired capacity to participate

Design outcomes

Primary

Measure	Time frame
Glycated haemoglobin (HbA1c) measured using blood test at baseline, 6 months and 12 months	—

Secondary

Measure	Time frame
1. Cholesterol measured using blood test at baseline, 6 months and 12 months 2. Haemoglobin measured using blood test at baseline, 6 months and 12 months 3. BMI measured using weight and height measurements at baseline, 6 months and 12 months 4. Waist circumference measured using standard trust procedures at baseline, 6 months and 12 months 5. Blood pressure measured using standard trust procedures at baseline, 6 months and 12 months 6. Smoking status assessed through participant self-report at baseline, 6 months and 12 months 7. Urinary albumin to creatinine ratio extracted from patient's medical notes at baseline 8. Physical activity measured using the International Physical Activity Questionnaire (IPAQ) at baseline, 6 months and 12 months 9. Psychiatric symptoms assessed using the Brief Psychiatric Rating Scale (BPRS) at baseline, 6 months and 12 months 10. Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9) at baseline, 6 months and 12 months 11. Diabetes distress assessed using the Problem Areas in Diabetes (PAID) scale at baseline, 6 months and 12 months 12. Summary of diabetes self-care activities assessed using the Summary of Diabetes Self-Care Activities Measure (SDSCA) at baseline, 6 months and 12 months 13. Insulin use assessed through participant self-report at baseline, 6 months and 12 months 14. Diabetes complications extracted from medical records at baseline, 6 months and 12 months 15. Health-related quality of life assessed using the EQ-5D-5L at baseline, 6 months and 12 months 16. Health resource use using a bespoke health resource use questionnaire at baseline, 6 months and 12 months 17. Mechanism of action measured using a set of self-report processes at baseline, 6 months and 12 months	—

Measure

Time frame

1. Cholesterol measured using blood test at baseline, 6 months and 12 months 2. Haemoglobin measured using blood test at baseline, 6 months and 12 months 3. BMI measured using weight and height measurements at baseline, 6 months and 12 months 4. Waist circumference measured using standard trust procedures at baseline, 6 months and 12 months 5. Blood pressure measured using standard trust procedures at baseline, 6 months and 12 months 6. Smoking status assessed through participant self-report at baseline, 6 months and 12 months 7. Urinary albumin to creatinine ratio extracted from patient's medical notes at baseline 8. Physical activity measured using the International Physical Activity Questionnaire (IPAQ) at baseline, 6 months and 12 months 9. Psychiatric symptoms assessed using the Brief Psychiatric Rating Scale (BPRS) at baseline, 6 months and 12 months 10. Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9) at baseline, 6 months and 12 months 11. Diabetes distress assessed using the Problem Areas in Diabetes (PAID) scale at baseline, 6 months and 12 months 12. Summary of diabetes self-care activities assessed using the Summary of Diabetes Self-Care Activities Measure (SDSCA) at baseline, 6 months and 12 months 13. Insulin use assessed through participant self-report at baseline, 6 months and 12 months 14. Diabetes complications extracted from medical records at baseline, 6 months and 12 months 15. Health-related quality of life assessed using the EQ-5D-5L at baseline, 6 months and 12 months 16. Health resource use using a bespoke health resource use questionnaire at baseline, 6 months and 12 months 17. Mechanism of action measured using a set of self-report processes at baseline, 6 months and 12 months

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 11, 2026