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OpenTrials
Completed

NCT Number: NCT03006510

Hypoglycemia Prediction Model

Our goal for this Learning Healthcare System Demonstration Project is to reduce the rate of inpatient hypoglycemia. Hypoglycemia can result in longer lengths of stay and increased morbidity and mortality (ie falls and cardiovascular or cerebral events).

The group at Washington University (WSL) developed a predictive hypoglycemia risk score. Using current glucose, body weight, creatinine clearance, insulin type and dosing, and oral diabetic therapy, they identified patients at high risk for hypoglycemia and then provided in-person education to the providers of these patients. This resulted in a 68% reduction in severe hypoglycemia (blood glucose < 40 mg/dL). This approach required significant personnel hours and is difficult to replicate in other systems.

The investigators will implement an EHR-based intervention at UCSF to predict which patients are at high risk of inpatient hypoglycemia and take action to prevent the hypoglycemic event. In real time, all adult (non OB) patients with a glucose < 90, and a high risk of future hypoglycemia (based on the WSL formula) will be identified. Patients will be randomly assigned to intervention or no intervention (current standard care). The intervention will consist of an automated provider alert with recommendations on what adjustments could be made to avoid a potentially serious hypoglycemic event.

The outcomes that will be measured include: 1) reductions in serious hypoglycemic events, 2) monitor the changes made by providers as a result of alerts in order to study provider behavior and identify future areas of intervention, and 3) provider satisfaction with the alert system.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All adult inpatients having glucoses measured (point of care)

Exclusion criteria

  • adults admitted to obstetrics

Treatment and study plan

Hypoglycemia prediction alert

Other

In real time, for a patient with a glucose <90 mg/d, using a hypoglycemia prediction model that takes into account patient weight, renal function, eating and insulin dosing a risk score is produced.

If the Risk score is >35, then the patient is determined to be at risk for hypoglycemia in the next 72 hours.

If a patient is determined to be at risk for hypoglycemia, the following will occur:

Alert will be generated and sent via "careweb" a pager alert system that sends the alert specifically to the current oncall provider The "alert" also points the provider to the EMR order section where a formal more detailed alert gives recommendationsd for changes in insulin dosing to potentially prevent hypoglycemia.

Primary outcomes

  1. The proportion of patients (in each group) who ultimately have a hypoglycemic event

    Time frame: 72 hours

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Leveraging the Power of the EMR: Using a Real Time Prediction Model to Decrease Inpatient Hypoglycemic Events

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 30, 2016
Registry last updated
Oct 8, 2021

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.

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