SCIPI - Subcutaneous Insulin: Pumps or Injections

Completed

• Conditions: Children with Type 1 Diabetes Mellitus; Nutritional, Metabolic, Endocrine; Insulin-dependant diabetes mellitus

• Registration Number: ISRCTN29255275
• Lead Sponsor: Alder Hey Children's NHS Foundation Trust (UK)

Brief Summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25873144 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/30109847

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-12
• Study Completion: 2014-06-30
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 316

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified