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

Diabetes Clinical Trial

— REMIND™  

Official title:

A Multicentre, Observational Study of NovoPen Echo® on Safety and Treatment Satisfaction of Insulin Therapy in Children and Adolescents With Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01180530
• Other study ID #: PDS328-3741
• Secondary ID: U1111-1113-5037
• Status: Completed
• Phase: N/A
• First received: August 6, 2010
• Last updated: February 6, 2017
• Start date: October 2010
• Est. completion date: March 2011

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 358
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Delivery Systems
• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Device:
• NovoPen Echo®
Prescribed insulin treatment delivered by NovoPen Echo®

Locations

Country	Name	City	State
Canada	Novo Nordisk Investigational Site	Mississauga
Finland	Novo Nordisk Investigational Site	Espoo
Israel	Novo Nordisk Investigational Site	Kfar Saba
Sweden	Novo Nordisk Investigational Site	Malmö
Sweden	Novo Nordisk Investigational Site	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Canada,  Finland,  Israel,  Sweden, 

References & Publications (2)

Adolfsson 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. — View Citation

Hansen B, Lilleøre 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: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of technical complaints related to adverse reactions		after 12-18 weeks (end of study)

External Links

•   Clinical Trials at Novo Nordisk