NCT01516242

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,819

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
Last Updated

November 7, 2016

Status Verified

November 1, 2016

Enrollment Period

1.2 years

First QC Date

January 19, 2012

Last Update Submit

November 4, 2016

Conditions

DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Delivery Systems

Outcome Measures

Primary Outcomes (3)

  • Number of insulin applications (punctures)

  • Reasons leading to change of the therapy

  • Patient satisfaction with NovoPen® 4 insulin delivery system

Secondary Outcomes (2)

  • Adverse reactions

  • Hypoglycaemia

Study Arms (1)

NovoPen® 4

Other: No treatment given

Interventions

No treatment givenOTHER

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

NovoPen® 4

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Bratislava, 811 05, Slovakia

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2012

First Posted

January 24, 2012

Study Start

October 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

November 7, 2016

Record last verified: 2016-11

Locations

SL(1)