Observational Study of NovoPen Echo® on Safety and Treatment Satisfaction in Children and Adolescents With Type 1 Diabetes

Completed

• Conditions: Delivery Systems; Diabetes; Diabetes Mellitus, Type 1

• Registration Number: NCT01180530
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Asia, Europe and North America. The aim of this observational study is to evaluate the safety of NovoPen Echo® by collecting safety information (incidence of technical complaints related to adverse reactions). Study duration: 12-18 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-06
• Study First Submitted QC: 2010-08-11
• Study First Posted: 2010-08-12
• Study Start: 2010-10
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 358

Inclusion Criteria

• Children/adolescents with type 1 diabetes mellitus
• After the participating physician's decision has been made to initiate treatment with NovoPen Echo®, any patient who meets all the inclusion criteria and does not meet any of the exclusion criteria, is eligible to participate
• Use of insulin pen or syringes for at least 12 months

Exclusion Criteria

• Insulin pump or Insuflon® users
• Any disease or condition in children/adolescents which might interfere with the study at the individual physician's discretion

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of technical complaints related to adverse reactions	after 12-18 weeks (end of study)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇪 Malmö, Sweden