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Investigating Novel Predictions of Hypoglycemia Occurrence in Real-world Models

NCT04219514

CompletedN/A

Sponsor: Stewart Harris

Conditions: Hypoglycemia, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1

Countries: United States

Hypoglycemia is the most common diabetes-related adverse event. However, it is often under-reported to healthcare providers by patients and simultaneously, not often asked about by healthcare providers. As a result, little is known about how often hypoglycemia occurs and consequently, which individuals with diabetes will experience such events. The aims of this study are to determine the real- world occurrence of hypoglycemia and develop/validate real-world risk prediction models for hypoglycemia. These risk prediction models will generate a risk score that indicates an individual's risk for hypoglycemia given their socio-demographic, clinical, and/or behaviour-related characteristics. They can be used to promote clinician awareness around patients' hypoglycemia risks, guide point- of-care and patient decision-making with regard to treatment changes, inform the development and conduct of population-based interventions, and lead to tailored, cost-effective management strategies.

Eligibility overview

Sex: ALL

Age: 18 Years to 90 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Self-reported diagnosis of T1DM or T2DM
* Use of insulin and/or secretagogues for at least one year at the time of enrolment
* Living in the United States of America for at least one year at the time of enrolment

Exclusion Criteria:

* Unable to read and understand English
* Currently pregnant or pregnant within the previous year
* Currently participating in an interventional clinical trial or research study

Locations (1)

New York, New York, United States