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

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

Sponsors

Lead sponsor: Novo Nordisk A/S

Source Novo Nordisk A/S
Brief Summary

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.

Overall Status Completed
Start Date September 5, 2012
Completion Date December 30, 2013
Primary Completion Date December 30, 2013
Study Type Observational
Primary Outcome
Measure Time Frame
Incidence of any hypoglycaemic event In the 4 weeks prior to and following the baseline visit (Week 0)
Secondary Outcome
Measure Time Frame
Difference in the reported incidence rates of any hypoglycaemia In the 4 weeks prior to (Part 1) versus following (Part 2) the baseline visit
Incidence of hypoglycaemic events requiring hospital admission In the 6 months prior to and 4 weeks following the baseline visit
Incidence of all severe hypoglycaemic events In the 6 months prior to and 4 weeks following the baseline visit
Incidence of probable symptomatic hypoglycaemic events In the 4 weeks prior to and following the baseline visit
Enrollment 29304
Condition
Intervention

Intervention type: Other

Intervention name: No treatment given

Description: 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).

Arm group label: Insulin-treated patients with diabetes

Eligibility

Sampling method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Global Clinical Registry (GCR, 1452) Study Director Novo Nordisk A/S
Location
facility
Novo Nordisk Investigational Site | Prov. De Buenos Aires, B1636DSU, Argentina
Novo Nordisk Investigational Site | Vienna, A-1010, Austria
Novo Nordisk Investigational Site | Sofia, 1407, Bulgaria
Novo Nordisk Investigational Site | Mississauga, L4W 4XI, Canada
Novo Nordisk Investigational Site | Zagreb, 10 000, Croatia
Novo Nordisk Investigational Site | Prague, 16000, Czechia
Novo Nordisk Investigational Site | Copenhagen S, 2300, Denmark
Novo Nordisk Investigational Site | Espoo, FI-02600, Finland
Novo Nordisk Investigational Site | Mainz, 55127, Germany
Novo Nordisk Investigational Site | Budapest, 1025, Hungary
Novo Nordisk Investigational Site | Bangalore, 560001, India
Novo Nordisk Investigational Site | Kfar Saba, 44425, Israel
Novo Nordisk Investigational Site | Amman, 11844, Lebanon
Novo Nordisk Investigational Site | Selangor Darul Ehsan, Malaysia
Novo Nordisk Investigational Site | Mexico City, Mexico
Novo Nordisk Investigational Site | Alphen A/d Rijn, Netherlands
Novo Nordisk Investigational Site | Warszawa, PL-02-274, Poland
Novo Nordisk Investigational Site | Bucharest, 010031, Romania
Novo Nordisk Investigational Site | Moscow, 119330, Russian Federation
Novo Nordisk Investigational Site | Riyadh, 3542, Saudi Arabia
Novo Nordisk Investigational Site | Belgrade, 11070, Serbia
Novo Nordisk Investigational Site | Bratislava, 811 05, Slovakia
Novo Nordisk Investigational Site | Ljubljana, SI-1000, Slovenia
Novo Nordisk Investigational Site | Malmö, 202 15, Sweden
Location Countries

Argentina

Austria

Bulgaria

Canada

Croatia

Czechia

Denmark

Finland

Germany

Hungary

India

Israel

Lebanon

Malaysia

Mexico

Netherlands

Poland

Romania

Russian Federation

Saudi Arabia

Serbia

Slovakia

Slovenia

Sweden

Verification Date

December 2018

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Insulin-treated patients with diabetes

Study Design Info

Observational model: Cohort

Time perspective: Cross-Sectional

Source: ClinicalTrials.gov