Type one diabetes Nutritional, Metabolic, Endocrine Insulin-dependent diabetes mellitus
Conditions
Interventions
The investigation is a mixed-method study informed by the 'Promoting Action on Research Implementation in Health Services' (PARIHS) framework which has been widely used to inform design and evaluation
Sponsors
Cardiff University (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children aged 6 - 18 years, either sex 2. Type one diabetes
Exclusion criteria
Exclusion criteria: 1. Severe learning difficulties 2. Significant social problems 3. Needle phobias
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Choice of outcomes is guided by Health Technology Assessment (HTA) commissioned systematic reviews recommending that HbA1c (glycaemic control measure) is not the appropriate primary outcome on which to assess benefits of an intervention designed to more directly effect behaviour/self-management. Therefore, the primary outcome measure is diabetes self-efficacy and quality-of-life using the Diabetes Pediatric Quality of Life Inventory (PedsQol). Outcomes will be measured at baseline, 3 months (follow-up 1) and 6 months (follow-up 2). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. HbA1c 2. Generic quality of life 3. Routinely collected NHS/child-held data costs 4. Service use 5. Acceptability/utility Outcomes will be measured at baseline, 3 months (follow-up 1) and 6 months (follow-up 2). | — |
Countries
United Kingdom
Outcome results
None listed