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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01180530
• Collaborator: (none)
• Enrollment: 358
• Locations: 5
• Duration (Months): 5
• Patients Per Site: 71.6
• Patients Per Site Per Month: 14.4

Study Details

Study Description

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	Phase
Diabetes; Diabetes Mellitus, Type 1; Delivery Systems	Device: NovoPen Echo®

Study Design

• 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: Oct 1, 2010
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
A	Device: NovoPen Echo®; Prescribed insulin treatment delivered by NovoPen Echo®

Outcome Measures

Primary Outcome Measures

1. The incidence of technical complaints related to adverse reactions [after 12-18 weeks (end of study)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Mississauga		Canada	L4W 4XI
2	Novo Nordisk Investigational Site	Espoo		Finland	FI-02600
3	Novo Nordisk Investigational Site	Kfar Saba		Israel	44425
4	Novo Nordisk Investigational Site	Malmö		Sweden	202 15
5	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT01180530
• Other Study ID Numbers: PDS328-3741; U1111-1113-5037
• First Posted: Aug 12, 2010
• Last Update Posted: Feb 8, 2017
• Last Verified: Feb 1, 2017

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Feb 8, 2017