Observational Study of NovoPen Echo® on Safety and Treatment Satisfaction in Children and Adolescents With Type 1 Diabetes
REMIND™
A Multicentre, Observational Study of NovoPen Echo® on Safety and Treatment Satisfaction of Insulin Therapy in Children and Adolescents With Diabetes Mellitus
2 other identifiers
observational
358
4 countries
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2010
Shorter than P25 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2010
CompletedFirst Posted
Study publicly available on registry
August 12, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedFebruary 8, 2017
February 1, 2017
5 months
August 6, 2010
February 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
The incidence of technical complaints related to adverse reactions
after 12-18 weeks (end of study)
Study Arms (1)
A
Interventions
Eligibility Criteria
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.
You may qualify if:
- Children/adolescents with type 1 diabetes mellitus
You may not qualify if:
- Use of insulin pen or syringes for at least 12 months
- Insulin pump or Insuflon® users
- Any disease or condition in children/adolescents which might interfere with the study at the individual physician's discretion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (5)
Novo Nordisk Investigational Site
Mississauga, L4W 4XI, Canada
Novo Nordisk Investigational Site
Espoo, FI-02600, Finland
Novo Nordisk Investigational Site
Kfar Saba, 44425, Israel
Novo Nordisk Investigational Site
Malmo, 202 15, Sweden
Novo Nordisk Investigational Site
Malmo, SE-202 15, Sweden
Related Publications (2)
Hansen B, Lilleore SK, Ter-Borch G. Needle with a novel attachment versus conventional screw-thread needles: a preference and usability test among adults with diabetes and impaired manual dexterity. Diabetes Technol Ther. 2011 May;13(5):579-85. doi: 10.1089/dia.2010.0214. Epub 2011 Mar 15.
PMID: 21406015RESULTAdolfsson P, Veijola R, Huot C, Hansen HD, Lademann JB, Phillip M. Safety and patient perception of an insulin pen with simple memory function for children and adolescents with type 1 diabetes--the REMIND study. Curr Med Res Opin. 2012 Sep;28(9):1455-63. doi: 10.1185/03007995.2012.698258. Epub 2012 Jul 27.
PMID: 22640459RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2010
First Posted
August 12, 2010
Study Start
October 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
February 8, 2017
Record last verified: 2017-02