Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
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.
Interventions
OTHERNo 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).
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of any hypoglycaemic event | In the 4 weeks prior to and following the baseline visit (Week 0) |
Secondary
| 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 |
Countries
Argentina, Austria, Bulgaria, Canada, Croatia, Czechia, Denmark, Finland, Germany, Hungary, India, Israel, Lebanon, Malaysia, Mexico, Netherlands, Poland, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, Sweden
Outcome results
None listed