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

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Prov. de Buenos Aires, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No treatment given

Other

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).

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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Sep 28, 2012
Registry last updated: Dec 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed