NovoLet® Acceptance Study Within the Hospital Practise in Indonesia

October 13, 2016 updated by: Novo Nordisk A/S

A Doctor and Nurse Survey on Using NovoLet® Within the Hospital Practice in Indonesia

This study is conducted in Asia. The aim of this study is to evaluate the overall acceptance of healthcare professionals (nurses and doctors) to the NovoLet® system used in a hospital environment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

203

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jakarta, Indonesia, 12520
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Individuals with either type 1 or type 2 diabetes, who were likely to be hospitalised and require insulin therapy in Indonesia

Description

Inclusion Criteria:

  • Type 1 diabetes
  • Type 2 diabetes
  • Likely to be hospitalised and require insulin therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Human insulin
Drug: insulin human
All subjects were treated with human insulin administered either by using the NovoLet® pre-filled insulin system or the conventional vial and syringe method. Doctors and nurses must personally administer at least 10 insulin doses to each patient under their individual clinical supervision for assessment of the NovoLet® pre-filled insulin system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall acceptance of the NovoLet® system among healthcare professionals (nurses and doctors)

Secondary Outcome Measures

Outcome Measure
Time taken for the healthcare professionals (nurses and doctors) to teach the patient
Incidence of adverse drug reactions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

December 12, 2011

First Submitted That Met QC Criteria

December 12, 2011

First Posted (Estimate)

December 14, 2011

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOPEN3-1887

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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