ClinicalTrials.gov
ClinicalTrials.gov Menu

Hypoglycemia Prediction Model

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03006510
Recruitment Status : Not yet recruiting
First Posted : December 30, 2016
Last Update Posted : December 30, 2016
Sponsor:
Information provided by (Responsible Party):
Robert Rushakoff, University of California, San Francisco

Brief Summary:

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.

We 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.


Condition or disease Intervention/treatment Phase
Hypoglycemia Other: Hypoglycemia prediction alert Early Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Official Title: Leveraging the Power of the EMR: Using a Real Time Prediction Model to Decrease Inpatient Hypoglycemic Events
Study Start Date : January 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Arm Intervention/treatment
Active Comparator: Alert
If glucose <90 mg/dl and hypoglycemia prediction score >35, then alert with suggestion for intervention sent to treating team
Other: Hypoglycemia prediction alert

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.


No Intervention: No alert
Routine standard care. If glucose <90 mg/dl and hypoglycemia prediction score >35, then report for investigators will be collected, but no active alert will be sent to teams.



Primary Outcome Measures :
  1. The proportion of patients (in each group) who ultimately have a hypoglycemic event [ Time Frame: 72 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • adults admitted to obstetrics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03006510


Contacts
Contact: Robert J Rushakoff, MD 4158853868 robert.rushakoff@ucsf.edu

Sponsors and Collaborators
University of California, San Francisco

Publications:

Responsible Party: Robert Rushakoff, Professor of Medicine, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03006510     History of Changes
Other Study ID Numbers: 16-20565
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: December 30, 2016
Last Verified: December 2016

Keywords provided by Robert Rushakoff, University of California, San Francisco:
inpatient diabetes
hypoglycemia

Additional relevant MeSH terms:
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases