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

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes; Delivery Systems

Treatments: Device: NovoPen Echo®

Study type: Observational

Funder types: Industry

Identifiers

NCT01180530

U1111-1113-5037 (Other Identifier)

PDS328-3741

Details and patient eligibility

About

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.

Enrollment: 358 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

358 participants in 1 patient group

A

Treatment:

Device: NovoPen Echo®