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Evaluation of Safety and Parameters of Application Technique

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ClinicalTrials.gov Identifier: NCT01516242
Recruitment Status : Completed
First Posted : January 24, 2012
Last Update Posted : November 7, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Delivery Systems Other: No treatment given

Study Design

Study Type : Observational
Actual Enrollment : 4819 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monitoring of Expected Parameters of the Application Technique and Safety of the Therapy
Study Start Date : October 2006
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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

Outcome Measures

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

Secondary Outcome Measures :
  1. Adverse reactions
  2. Hypoglycaemia

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT01516242     History of Changes
Other Study ID Numbers: MS236-1926
First Posted: January 24, 2012    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: November 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