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Completed

NCT Number: NCT01180530

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

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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Key information

Conditions

Diabetes Autoimmune Diseases Delivery Systems Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Mississauga, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NovoPen Echo®

Device

Prescribed insulin treatment delivered by NovoPen Echo®

Primary outcomes

  1. The incidence of technical complaints related to adverse reactions

    Time frame: after 12-18 weeks (end of study)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multicentre, Observational Study of NovoPen Echo® on Safety and Treatment Satisfaction of Insulin Therapy in Children and Adolescents With Diabetes Mellitus

Acronym: REMIND™

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 12, 2010
Registry last updated
Feb 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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