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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

358 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1 Delivery Systems

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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A

NovoPen Echo®

Intervention Type DEVICE

Prescribed insulin treatment delivered by NovoPen Echo®

Interventions

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NovoPen Echo®

Prescribed insulin treatment delivered by NovoPen Echo®

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Children/adolescents with type 1 diabetes mellitus
* 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

Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No