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Delivering Early Care In Diabetes Evaluation (DECIDE): To assess hospital versus home management at diagnosis in childhood type 1 diabetes - a comparison of psychological, social, physical and economic outcomes

Delivering Early Care In Diabetes Evaluation (DECIDE): To assess hospital versus home management at diagnosis in childhood type 1 diabetes - a comparison of psychological, social, physical and economic outcomes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN78114042
Enrollment
240
Registered
2007-11-09
Start date
2008-01-01
Completion date
Unknown
Last updated
2021-06-07

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

Conditions

Type 1 diabetes Nutritional, Metabolic, Endocrine Insulin-dependent diabetes mellitus

Interventions

Patients will be randomised to either: 1. Home management 2. Hospital managment Patients and their parents will be randomised on the day of diagnosis t

Sponsors

Cardiff University (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
Glycaemic control (HbA1c) over the 2 years post diagnosis. Measurements will be taken at 0, 1, 12 and 24 months.

Secondary

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 29, 2026