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

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ClinicalTrials.gov Identifier: NCT01180530
Recruitment Status : Completed
First Posted : August 12, 2010
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 1 Delivery Systems Device: NovoPen Echo®

Study Type : Observational
Actual Enrollment : 358 participants
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
Study Start Date : October 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
A Device: NovoPen Echo®
Prescribed insulin treatment delivered by NovoPen Echo®



Primary Outcome Measures :
  1. The incidence of technical complaints related to adverse reactions [ Time Frame: after 12-18 weeks (end of study) ]


Information from the National Library of Medicine

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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

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

Additional Information:
Publications of Results:
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 Posted: August 12, 2010    Key Record Dates
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