Type 1 diabetes Nutritional, Metabolic, Endocrine Insulin-dependent diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children aged 0 - 17 years old 2. Newly diagnosed type 1 diabetes (using recognised standard diagnostic criteria) who are clinically well (pH greater than 7.29) at presentation 3. Written informed consent given by parent(s)/carer/child and assent from child 4. Able to fill out study material (all parents and children aged greater than or equal to 8 years old)
Exclusion criteria
Exclusion criteria: 1. Children with a coexisting chronic disorder (e.g., cystic fibrosis) which will impact significantly on blood glucose control 2. Children with type 2 diabetes 3. Children with Maturity Onset Diabetes of the Young (MODY) 4. Children with an uncertain diagnosis 5. Children who are under the care of the local authority 6. Children whose home circumstances are assessed as being unsuitable for home management 7. Children who require hospitalisation for reasons other than their diagnosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycaemic control (HbA1c) over the 2 years post diagnosis. Measurements will be taken at 0, 1, 12 and 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical: growth (height, weight, body mass index [BMI]) and adverse events (e.g. severe hypoglycaemia) 2. Patient: quality of life, coping with diabetes, diabetes knowledge, satisfaction and time off school 3. Parent: anxiety, coping with diabetes, diabetes knowledge, satisfaction and time off work 4. Health professionals: experience of both approaches to care 5. Health resource usage: hospitalisation, home and clinic visits Measurements will be taken at 0, 1, 12 and 24 months. | — |
Countries
United Kingdom