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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01180530
First received: August 6, 2010
Last updated: November 15, 2016
Last verified: November 2016

August 6, 2010
November 15, 2016
October 2010
March 2011   (final data collection date for primary outcome measure)
The incidence of technical complaints related to adverse reactions [ Time Frame: after 12-18 weeks (end of study) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01180530 on ClinicalTrials.gov Archive Site
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Observational Study of NovoPen Echo® on Safety and Treatment Satisfaction in Children and Adolescents With Type 1 Diabetes
A Multicentre, Observational Study of NovoPen Echo® on Safety and Treatment Satisfaction of Insulin Therapy in Children and Adolescents With Diabetes Mellitus
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.
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Observational
Time Perspective: Prospective
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Non-Probability Sample
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.
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Delivery Systems
Device: NovoPen Echo®
Prescribed insulin treatment delivered by NovoPen Echo®
A
Intervention: Device: NovoPen Echo®
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
358
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
2 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Finland,   Israel,   Sweden
 
NCT01180530
PDS328-3741, U1111-1113-5037
No
Not Provided
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Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP