Status:
COMPLETED
Pizza-Salami Study in Children and Adolescents With Type 1 Diabetes
Lead Sponsor:
Kinderkrankenhaus auf der Bult
Collaborating Sponsors:
Medtronic
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
6-21 years
Phase:
PHASE4
Brief Summary
The Pizza-Salami-Study aims to investigate the efficacy of carbohydrate plus fat/protein (CFP) counting compared with carbohydrate (CARB) counting using normal and dual-wave bolus in sensor-augmented ...
Detailed Description
This is a prospective, international multi-centre, open randomized clinical trial to assess whether the use of Paradigm REAL-Time System from the onset of Type 1 Diabetes (T1D) leads to a better glyca...
Eligibility Criteria
Inclusion
- Patients with type 1 diabetes
- Age 6 - 21 years
- Diabetes duration \> 1 year
- Treatment with pump therapy (CSII) \> 3 months
- Written informed consent by patients and parents
- Patients must be willing to wear a glucose sensor for two days and to perform capillary blood glucose measurement twice a day
- Patients must be willing to performed all study procedures
Exclusion
- Language barriers
- Eating disorders
- Pregnancy
- Drug abuse
- Patient refutes participation or study procedures
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01400659
Start Date
March 1 2009
End Date
November 1 2009
Last Update
December 18 2015
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