A randomised controlled trial of continuous subcutaneous insulin infusion(CSII) compared to multiple daily injection(MDI) regimens on insulin in children and young people at diagnosis of type I diabetes mellitus (TIDM). - Subcutaneous Insulin: Pumps or Injections (SCIPI) Version Number 3.0

Phase 1

• Conditions: Type 1 Diabetes Mellitus; MedDRA version: 15.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

• Registration Number: EUCTR2010-023792-25-GB
• Lead Sponsor: Alder Hey Children's NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-09
• Study Completion: 2017-01-30
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 293

Inclusion Criteria

Patients with the following characteristics will be eligible for inclusion in the trial:
a.Newly diagnosed TIDM using standard diagnostic practice (26);
b.Age 7 months – 15 years (inclusive);
c.Parent/legal representative of the patient are willing to give consent for the study;
d.Parent/legal representative of the patient are able to comply with the treatment regimen and study visits;
e.Patient aged 8 years and over are able to comply with the treatment regimen and study visits.

Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Patients with the following characteristics will be excluded from the trial:
a.Treated previously for diabetes;
b.Haemoglobinopathy;
c.Co-existing pathology conditions likely to affect glycaemic control,
e.g. cystic fibrosis;
d.Psychological or psychiatric disorders, e.g. eating disorder;
e.Receipt of medication likely to affect glycaemic control, e.g. systemic or
high dose topical corticosteroid or growth hormone therapy;
f.Allergy to a component of insulin aspart or insulin glargine;
g.Have a sibling with existing TIDM;
h.Known thyroid condition in a non euthyroid state and;
i.Known Coeliac disease unable to maintain a gluten free diet.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified