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Evaluation of Safety and Parameters of Application Technique

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: January 19, 2012
Last updated: November 4, 2016
Last verified: November 2016
This study is conducted in Europe. The aim of the study is to monitor patients changing therapy from syringe to insulin delivery system as prescribed by the treating physician in Slovakia.

Condition Intervention
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Delivery Systems Other: No treatment given

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monitoring of Expected Parameters of the Application Technique and Safety of the Therapy

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Number of insulin applications (punctures)
  • Reasons leading to change of the therapy
  • Patient satisfaction with NovoPen® 4 insulin delivery system

Secondary Outcome Measures:
  • Adverse reactions
  • Hypoglycaemia

Enrollment: 4819
Study Start Date: October 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
NovoPen® 4 Other: No treatment given
Collection of data about patients with type 1 diabetes or type 2 diabetes treated with insulin changing their insulin administration from syringe to a insulin delivery system based on completion of questionaire


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with type 1 diabetes or type 2 diabetes mellitus treated with insulin having changed administration of inulin from syringe to a Novo Nordisk insulin delivery system

Inclusion Criteria:

  • Diabetes mellitus (type 1 or type 2)
  • Treated with insulin
  Contacts and Locations
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Please refer to this study by its identifier: NCT01516242

Novo Nordisk Investigational Site
Bratislava, Slovakia, 811 05
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT01516242     History of Changes
Other Study ID Numbers: MS236-1926
Study First Received: January 19, 2012
Last Updated: November 4, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases processed this record on September 25, 2017