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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
ClinicalTrials.gov Identifier:
NCT01180530
First received: August 6, 2010
Last updated: June 20, 2012
Last verified: June 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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
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
Investigators
Study Director: Jacob Lademann Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

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
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013