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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01180530
First received: August 6, 2010
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 1
Delivery Systems
Device: NovoPen Echo®

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Multicentre, Observational Study of NovoPen Echo® on Safety and Treatment Satisfaction of Insulin Therapy in Children and Adolescents With Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • The incidence of technical complaints related to adverse reactions [ Time Frame: after 12-18 weeks (end of study) ] [ Designated as safety issue: No ]

Enrollment: 358
Study Start Date: October 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Device: NovoPen Echo®
Prescribed insulin treatment delivered by NovoPen Echo®

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any child or adolescent with type 1 diabetes who has just started using NovoPen Echo® is eligible. The selection of the patients will be at discretion of the individual physician.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01180530

Locations
Canada
Mississauga, Canada, L4W 4XI
Finland
Espoo, Finland, FI-02600
Israel
Kfar Saba, Israel, 44425
Sweden
Malmö, Sweden, SE-202 15
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Jacob Lademann Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01180530     History of Changes
Other Study ID Numbers: PDS328-3741, U1111-1113-5037
Study First Received: August 6, 2010
Last Updated: June 20, 2012
Health Authority: Canada: Not required for observational study
Finland: Not required for observational study
Israel: Not required for observational study
Sweden: Not required for observational study

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 20, 2014