Insight Kids Study - RD002177
Research type
Research Study
Full title
Insight Kids Study: Reaching HbA1c Targets in Children and Adolescents with Type 1 Diabetes: A Randomized, Controlled Trial Comparing Continuous Subcutaneous Insulin Infusion with Multiple Daily Injections
IRAS ID
169843
Contact name
Ruth Krone
Contact email
Sponsor organisation
Roche Diagnostics GmbH - Diabetes Care
Duration of Study in the UK
1 years, 1 months, 29 days
Research summary
When treating patients with type 1 diabetes, insulin can be administered either by multiple daily injections, or by infusion using an insulin pump. Both types of treatment are well-established in diabetes therapy. The aim of this study is to assess whether insulin injection therapy or insulin pump therapy is more effective in treating children and adolescents 6 to 17 years of age with type 1 diabetes who have previously not been treated with insulin pump therapy. At study start, patients will be randomly allocated to either injection or insulin pump therapy. The percentages of patients reaching their goals for glycemic control with the two types of insulin therapy after 6 months will be compared. In addition, treatment satisfaction and factors of health-related quality of life will be assessed by means of surveys. From month 6 onwards, all patients will be treated for another 3 months with insulin pump therapy. In addition, young children 2 to 5 years of age will all be treated with insulin pump therapy in this study for 9 months. Insulin pump therapy is already the standard therapy in children of this age. For insulin pump therapy, the Accu Chek® Insight system will be used. The two main components of this system are an insulin pump and a handset. The study will be conducted in diabetes centres experienced in insulin pump therapy. Further to routine therapy procedures, patients will undergo blood tests every 3 months for assessing the long-term glycemic control. The study results are expected to help decide which therapy is more beneficial for children and adolescents with type 1 diabetes. The study results will also contribute to the clinical evidence of the use of the Accu-Chek® Insight system in patients with diabetes requiring insulin. The study is funded by Roche Diagnostics.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
15/WM/0230
Date of REC Opinion
18 Aug 2015
REC opinion
Further Information Favourable Opinion