Preventing Hypoglycemia

June 19, 2014 updated by: Washington University School of Medicine

Prevention of Hypoglycemia and Insulin Errors in Barnes-Jewish Hospital Inpatients

The purpose of the project is to improve in-patient safety by lowering the risk of severe hypoglycemia (low blood sugar) for patients with diabetes on insulin therapy and to improve communication between healthcare providers.

The procedures of the study are:

  • the hospital patient information system [Pharmacy Event System,(PES)] will generate for healthcare providers a real-time risk alert of severe hypoglycemia (low blood sugar)
  • the real-time PES risk alert will be sent via a beeper to the patient's charge nurse
  • the charge nurse will follow the specific guidelines in the alert for assessment of the patient's care and insulin regimen
  • the charge nurse will then notify the physician of the patient's assessment and of the recommendation for change/no change in insulin regimen and/or clinical care
  • the alerted charge nurse and physician will complete a collaboration scale

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This prospective nonrandomized intervention study involved inpatients admitted to 6 designated intervention and 8 designated control acute medicine divisions at Barnes-Jewish Hospital in St Louis, the academic teaching hospital of Washington University School of Medicine, from August 2011 through December 2011. The study population consisted of patients cared for on either the control or intervention floors who were receiving anti-diabetic medications during their hospital stay. The study was approved by the Washington University Medical Center institutional review board, and included a waiver of consent for all patients.

The pharmacy informatics system was programmed with the previously-developed hypoglycemia alert parameters to identify those patients at high risk of hypoglycemia based on real-time patient information (7). Patients were identified as high risk on intervention floors if insulin or an oral anti-hyperglycemic agent was prescribed, if their hypoglycemia informatics-generated risk score was greater than 35, and if they had a capillary or venous blood glucose level of ≤90 mg/dL. The risk score of 35 was the value that corresponded to 50% sensitivity for a subsequent blood glucose < 60 mg/ dl and a 75% sensitivity for a blood glucose < 40 mg/ dL. Patients were assigned to categories based on the division that they were admitted to and risk score algorithm.

The electronic alert was sent to division-specific charge nurses via a pager. Fourteen charge nurses on intervention divisions were trained to assess the alert, interview the patient, identify an alternate dosing strategy and collaborate with the patient's physicians. These trained nurses were available on intervention divisions Monday through Friday from 0700 to 1700. Control patients (HR-) were identified as high risk on control divisions based on the same criteria as intervention patients. The control patients' charts were reviewed upon discharge of the patient by a certified diabetes nurse educator on the research team who evaluated the number of hypoglycemic episodes in these patients as well as physician recognition of increased risk and whether appropriate changes were made to the patient orders in response to a low or down-trending blood glucose levels.

Nurses and physicians caring for patients on study divisions provided informed consent to participate in the study. Nurses' satisfaction with the alert process and physician interaction was assessed with a collaboration scale that was completed after each alert as well as a post study satisfaction scale (9). Nurses and physicians provided informed consent to participate.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
390

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inclusion criteria for participating charge nurses and physicians is the insulin management educational classes and the pre/post quiz. No exclusion criteria.

Exclusion Criteria:

  • No exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Informatics Real-Time Alert
Alert/Nurse and Physician Intervention
Other: Informatics Alert/Nurse/physician responders
NO_INTERVENTION: control-no intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Severe Hypoglycemia
Time Frame: from time of the Pharmacy Expert System (PES) alert until discharge of the patient from the hospital, an average of 3-5 days
The incidence of Severe Hypoglycemia (<40mg/dl) in patients after receiving a PES Hypoglycemia Risk Alert until discharge from the hospital in both intervention and control groups.
from time of the Pharmacy Expert System (PES) alert until discharge of the patient from the hospital, an average of 3-5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Garry Tobin, MD, Washington University School of Medicine St. Louis, Missouri

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 20, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201104182

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