An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes

December 7, 2018 updated by: Novo Nordisk A/S
This study is conducted in Europe. The aim of the study is to gather information about hypoglycaemia (low blood glucose) among patients with Type 1 or Type 2 diabetes mellitus. The study is both retrospective and prospective.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

29304

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

  • Argentina
      • Prov. De Buenos Aires, Argentina, B1636DSU
        • Novo Nordisk Investigational Site
  • Austria
      • Vienna, Austria, A-1010
        • Novo Nordisk Investigational Site
  • Bulgaria
      • Sofia, Bulgaria, 1407
        • Novo Nordisk Investigational Site
  • Canada
      • Mississauga, Canada, L4W 4XI
        • Novo Nordisk Investigational Site
  • Croatia
      • Zagreb, Croatia, 10 000
        • Novo Nordisk Investigational Site
  • Czechia
      • Prague, Czechia, 16000
        • Novo Nordisk Investigational Site
  • Denmark
      • Copenhagen S, Denmark, 2300
        • Novo Nordisk Investigational Site
  • Finland
      • Espoo, Finland, FI-02600
        • Novo Nordisk Investigational Site
  • Germany
      • Mainz, Germany, 55127
        • Novo Nordisk Investigational Site
  • Hungary
      • Budapest, Hungary, 1025
        • Novo Nordisk Investigational Site
  • India
      • Bangalore, India, 560001
        • Novo Nordisk Investigational Site
  • Israel
      • Kfar Saba, Israel, 44425
        • Novo Nordisk Investigational Site
  • Lebanon
      • Amman, Lebanon, 11844
        • Novo Nordisk Investigational Site
  • Malaysia
      • Selangor Darul Ehsan, Malaysia
        • Novo Nordisk Investigational Site
  • Mexico
      • Mexico City, Mexico
        • Novo Nordisk Investigational Site
  • Netherlands
      • Alphen A/d Rijn, Netherlands
        • Novo Nordisk Investigational Site
  • Poland
      • Warszawa, Poland, PL-02-274
        • Novo Nordisk Investigational Site
  • Romania
      • Bucharest, Romania, 010031
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 119330
        • Novo Nordisk Investigational Site
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 3542
        • Novo Nordisk Investigational Site
  • Serbia
      • Belgrade, Serbia, 11070
        • Novo Nordisk Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 811 05
        • Novo Nordisk Investigational Site
  • Slovenia
      • Ljubljana, Slovenia, SI-1000
        • Novo Nordisk Investigational Site
  • Sweden
      • Malmö, Sweden, 202 15
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Insulin-treated patients with Type 1 or Type 2 diabetes mellitus. Patients should be ambulatory, literate, have used insulin for at least 12 months, and be over 18 years of age to be able to participate in the study.

Description

Inclusion Criteria:

  • Patients with Type 1 or Type 2 diabetes mellitus treated with insulin for more than 12 months
  • Patients giving informed consent to participate in the survey

Exclusion Criteria:

  • Non-ambulatory patients
  • Illiterate patients and patients otherwise unable to complete a written survey

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Insulin-treated patients with diabetes
Other: No treatment given
Patients will be asked to complete a two-part patient self-assessment questionnaire (SAQ) comprising a retrospective cross-sectional evaluation (Part 1), and a prospective observational evaluation (Part 2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of any hypoglycaemic event
Time Frame: In the 4 weeks prior to and following the baseline visit (Week 0)
In the 4 weeks prior to and following the baseline visit (Week 0)

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference in the reported incidence rates of any hypoglycaemia
Time Frame: In the 4 weeks prior to (Part 1) versus following (Part 2) the baseline visit
In the 4 weeks prior to (Part 1) versus following (Part 2) the baseline visit
Incidence of hypoglycaemic events requiring hospital admission
Time Frame: In the 6 months prior to and 4 weeks following the baseline visit
In the 6 months prior to and 4 weeks following the baseline visit
Incidence of all severe hypoglycaemic events
Time Frame: In the 6 months prior to and 4 weeks following the baseline visit
In the 6 months prior to and 4 weeks following the baseline visit
Incidence of probable symptomatic hypoglycaemic events
Time Frame: In the 4 weeks prior to and following the baseline visit
In the 4 weeks prior to and following the baseline visit

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.

General Publications

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 (Actual)

September 5, 2012

Primary Completion (Actual)

December 30, 2013

Study Completion (Actual)

December 30, 2013

Study Registration Dates

First Submitted

September 26, 2012

First Submitted That Met QC Criteria

September 27, 2012

First Posted (Estimate)

September 28, 2012

Study Record Updates

Last Update Posted (Actual)

December 11, 2018

Last Update Submitted That Met QC Criteria

December 7, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INS-4019
  • U1111-1132-1910 (Other Identifier: WHO)

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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