Investigating Novel Predictions of Hypoglycemia Occurrence in Real-world Models
Completed
Conditions studied: Hypoglycemia, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
In brief
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.
Key facts
- Study ID
- NCT04219514
- Run by
- Stewart Harris
- People needed
- 1206
- Starts
- 2020-02-10
- Expected to finish
- 2021-03-30
- Last updated by the study team
- 2021-04-13
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Unable to read and understand English
- Currently pregnant or pregnant within the previous year
- Currently participating in an interventional clinical trial or research study
Where it is running
- Ipsos — New York, New York, United States
Full record on ClinicalTrials.gov
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