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OpenTrials
Completed

NCT Number: NCT01516242

Evaluation of Safety and Parameters of Application Technique

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Delivery Systems Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Bratislava, 811 05, Slovakia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diabetes mellitus (type 1 or type 2)
  • Treated with insulin

Treatment and study plan

No treatment given

Other

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

Primary outcomes

  1. Number of insulin applications (punctures)

  2. Reasons leading to change of the therapy

  3. Patient satisfaction with NovoPen® 4 insulin delivery system

Secondary outcomes

  1. Adverse reactions

  2. Hypoglycaemia

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Monitoring of Expected Parameters of the Application Technique and Safety of the Therapy

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jan 24, 2012
Registry last updated
Nov 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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