We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT01180530
First Posted: August 12, 2010
Last Update Posted: February 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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: Observational Model: Other
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) ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180530


Locations
Canada
Novo Nordisk Investigational Site
Mississauga, Canada, L4W 4XI
Finland
Novo Nordisk Investigational Site
Espoo, Finland, FI-02600
Israel
Novo Nordisk Investigational Site
Kfar Saba, Israel, 44425
Sweden
Novo Nordisk Investigational Site
Malmö, Sweden, 202 15
Novo Nordisk Investigational Site
Malmö, Sweden, SE-202 15
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01180530     History of Changes
Other Study ID Numbers: PDS328-3741
U1111-1113-5037 ( Other Identifier: WHO )
First Submitted: August 6, 2010
First Posted: August 12, 2010
Last Update Posted: February 8, 2017
Last Verified: February 2017

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