Children with Type 1 Diabetes Mellitus Nutritional, Metabolic, Endocrine Insulin-dependant diabetes mellitus
Conditions
Interventions
Participants will be randomised in a 1:1 ratio to either of the two treatments
1. Arm A (Multiple Dose Injection of Insulin (MDI) treatment): Insulin aspart and insulin glargine will be delivered subc
Sponsors
Alder Hey Children's NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed TIDM using standard diagnostic practise (WHO Definition 2006) 2. Age 6 months - 15 years (inclusive) 3. Willing to give consent for the study
Exclusion criteria
Exclusion criteria: 1. Treated previously for diabetes 2. Haemoglobinopathy 3. Co-existing pathology conditions likely to affect glycaemic control, e.g. cystic fibrosis 4. Psychological or psychiatric disorders, e.g. eating disorder 5. Receipt of medication likely to affect glycaemic control, e.g. systemic or high dose topical corticosteroid or growth hormone therapy 6. Allergy to a component of insulin aspart or insulin glargine 7. Patient who have a first degree relative with existing TIDM Patients previously diagnosed with coeliac disease or thyroid dysfunction will be eligible to join the study if they have maintained a gluten-free diet/been maintained in a euthyroid state for 3 months prior to the diagnosis of TIDM.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pilot study Fifty percent or more subjects who are eligible and are invited to participate in the pilot study are successfully recruited. Full study Glycaemic control (HbA1c) 12 months after diagnosis | — |
Secondary
| Measure | Time frame |
|---|---|
| Pilot study Demographic characteristics like age, gender and deprivation score are not significantly different in the group of subjects who are recruited compared to those who decline. These characteristics will be measured at the end of the pilot phase (at 6 months) before open the trial for full study. Full study 1. Percentage of patients in each group with HbA1c <7.5%, measured at baseline, 3, 6, 9 and 12 months 2. Prevalence of adverse events (including severe hypoglycaemia) at 3, 6, 9 and 12 months 3. Change in Body Mass Index Standard Deviation Score (BMI SDS) at 3, 6, 9 and 12 months 4. Insulin requirements (units / kg /day) at 3, 6, 9 and 12 months 5. Quality of Life (QoL) assessed by PedsQL questionnaire at baseline, 6 and 12 months 6. Incremental cost per Quality-Adjusted Life-Year (QALY) gained at 12 months | — |
Countries
United Kingdom
Outcome results
None listed