Paediatric onset study to assess the efficacy of insulin pump therapy using the MiniMed Paradigm® REAL-Time system during the first year of diabetes in children and adolescents with type 1 diabetes

Completed

• Conditions: Type 1 diabetes mellitus; Nutritional, Metabolic, Endocrine; Insulin-dependent diabetes mellitus

• Registration Number: ISRCTN05450731
• Lead Sponsor: Hannover Childrens Hospital (Hannoversche Kinderheilanstalt) (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-31
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Provided written informed consent
2. Aged between 1 (inclusive) and 17 (exclusive) years (either sex) and diagnosed with type 1 diabetes at latest 4 weeks prior to study entry
3. Patients must be willing to use the MiniMed Paradigm® REAL-Time system or MiniMed Paradigm® 515/715 insulin pump combined to conventional SMBG finger sticks for 12 months
4. Patients must be able and willing to perform at least two SMBG finger sticks daily
5. Patients are willing to undergo all study procedures
6. Training on how to adapt their insulin dose to their meals and awareness of how to calculate and apply corrective insulin boluses as well as of the influence of physical activity and their life style factors on their metabolic control
7. Patients are willing to participate to the MiniMed Paradigm® REAL-Time system (Group A) and to the MiniMed Paradigm® 515/715 plus the Guardian REAL-Time Clinical (Group B)

Exclusion Criteria

1. Hearing or vision impairment so that alarms cannot be recognised
2. Patient does not have reliable support person or is unwilling to comply with the provisions of the protocol
3. Mental incapacity
4. Language barriers precluding adequate understanding or cooperation
5. Patients suffering from severe chronic disease or genetic disorder other than type 1 diabetes (i.e. Down syndrome, etc.)
6. Pregnancy
7. Eating disorders
8. Alcohol or drug abuse other than nicotine
9. Patients participating in other device or drug related studies
10. Patients disclaimer of study participation

Study & Design

• Study Type: Interventional
• Study Design: Not specified