Evaluation of Safety and Parameters of Application Technique

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Delivery Systems
• Interventions: Other: No treatment given

• Registration Number: NCT01516242
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2012-01-19
• Study First Submitted QC: 2012-01-19
• Study First Posted: 2012-01-24
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-04
• Last Update Posted: 2016-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4819

Inclusion Criteria

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NovoPen® 4	No treatment given	-

Primary Outcome Measures

Name	Time	Method
Number of insulin applications (punctures)
Reasons leading to change of the therapy
Patient satisfaction with NovoPen® 4 insulin delivery system

Secondary Outcome Measures

Name	Time	Method
Adverse reactions
Hypoglycaemia

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇰 Bratislava, Slovakia