Tight glycaemic control” and the risk of hypoglycaemia: Is this different between multiple injections versus insulin pump therapy? A UK multi-centre, open randomised control trial. - DUK Pump Study

• Conditions: Type 1 diabetes mellitus in children and adolescents; MedDRA version: 9.1Level: LLTClassification code 10012609Term: Diabetes mellitus juvenile onset

• Registration Number: EUCTR2008-002711-41-GB
• Lead Sponsor: niversity of Dundee (Research & Innovation Services)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

We will recruit 10 children and adolescents (8 to 16 yrs).
The centre will enroll subjects on the understanding that they will be allowed to continue managing their diabetes with CSII if this is the subjects choice, after completion of the study, supported by their local clinic.
Each subject should have been diagnosed with diabetes for one year and currently be treated with MDI therapy for at least six months. Glycaemic control should be consistent with an HbA1c <10.5%.
Each recruit should expect to comply with a rigorous programme of monitoring and insulin adjustment (see below).
All subjects should have a mobile phone (with basic SMS facility) and be prepared to receive a daily message throughout the study.
All patients should accept the requirement of Glycaemic excursion using continuous glocuse monitoring over 3-10 days at the begining of each treatment arm and Blind Glycaemic excursion using continuous glocuse monitoring over 3-10 days at the run-in period and at the end of each treatment arm.
To ensure a cohesive approach to hypoglycaemiic care by parent, recruit and clinical staff, hypoglycaemia is classified and managed using the Sympotomatic Hypoglycaemia guideline.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Diabetes diagnosed less than one year.
Current glycated haemoglobin >10.5%
Subjects with vascular complications of diabetes.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the prevalence and incidence of clinical hypoglycaemia in children and adolescents with Type 1 Diabetes Mellitus treated either with multiple daily subcutaneous injections of fast and long-acting insulin with fast acting insulin delivered by continous insulin infusion (CSII using an insulin pump).;Secondary Objective: ;Primary end point(s): Incidence and prevalence of hypoglycaemia as measured by home blood glucose testing using capillary blood glucose monitoring, patient diaries of clinical episodes and intermittent monitoring using continuous glucose monitoring system.