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

Novo Nordisk A/S29,304 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

29,304

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventions

No treatment givenOTHER

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).

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (24)

Novo Nordisk Investigational Site

Prov. de Buenos Aires, Argentina

Outcomes

Primary Outcomes

Incidence of any hypoglycaemic event

Time frame: In the 4 weeks prior to and following the baseline visit (Week 0)

Secondary Outcomes

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

Incidence of hypoglycaemic events requiring hospital admission

Time frame: 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

Incidence of probable symptomatic hypoglycaemic events

Time frame: In the 4 weeks prior to and following the baseline visit

Data from ClinicalTrials.gov

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