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Investigating Novel Predictions of Hypoglycemia Occurrence in Real-world Models

NCT04219514 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1206

Last updated 2021-04-13

No results posted yet for this study

Summary

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.

Conditions

  • Hypoglycemia
  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus, Type 1

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Stewart Harris

    lead OTHER

Principal Investigators

  • Stewart Harris, MD MPH · Western University

  • Alexandria Ratzki-Leewing, PhD(c) MSc · Western University

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-10
Primary Completion
2021-03-30
Completion
2021-03-30

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04219514 on ClinicalTrials.gov