Diabetes Clinical Decision Support

May 12, 2026 updated by: Ariana Pichardo-Lowden, Milton S. Hershey Medical Center

Glucose Management Clinical Decision Support to Improve Outcomes in Academic and Community Hospitals

The purpose of this study is to determine the impact of an electronic medical record clinical decision support tool on rates of dysglycemia in the hospital, and its clinical and economical outcomes. The study also evaluates the perspectives of providers regarding the tool's usefulness on disease management support, knowledge, and practice performance.

Study Overview

Status

Status

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

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

Approximately 9 million patients with diabetes (DM) are hospitalized annually and over 30% of inpatients without DM experience high glucose (HG) due to their acute illness. HG increases the risk of infectious and non- infectious complications and death, hospital length of stay (LOS), utilization of hospital resources and overall healthcare costs. While glucose control reduces these risks, controlling HG in the hospital is difficult due to multiple barriers such as recognizing and proactively treating glucose abnormalities, and adequately ordering insulin to treat HG in the hospital. Clinical decision support (CDS) is a system that uses computerized person- specific data in the electronic medical record (EMR) proven to improve hospital care. Among the various modalities, alert-CDS is shown to improve care delivery, providers' proactivity, and glucose control specifically in intensive care settings of academic institutions. However, alert-CDS has not yet been studied outside of intensive care units (ICU), or in community hospitals where most patients receive care. Furthermore, its impact on patients' outcomes has not been tested in any setting. The proposed project uses an innovative alert-CDS tool the investigators developed and validated which automatically identifies dysglycemia and inadequacies in insulin administration in the hospital. It alerts clinicians with recommendations to support decision making without superseding their clinical judgement. In the pilot study, it was found that this alert-CDS tool reduced recurrent high glucose levels and shortened LOS. Based on this promising preliminary data, in this project the investigators propose to study the impact of our CDS tool on clinical, economic and providers' performance outcomes among non-intensive care patients both in academic and community hospitals. This resource will be available intermittently in the EMR every 3 months for 36 months, thus allowing the comparison of 18 months of intervention and 18 months of standard care. Based on the pilot study, a sample size of 12,560 subjects will give an 80% power of detecting 0.34 days (~ 8 hours) difference in length of stay, the primary endpoint of our study. The investigators propose the following aims: Aim 1) To determine the impact of the alert-CDS over conventional care on the clinical outcomes of non-ICU patients in an academic and four community hospitals. Aim 2) To determine the impact of the alert-CDS over conventional care on the economic outcomes of non-ICU patients in an academic and four community hospital. Aim 3) To determine the impact of alert-CDS for inpatient glycemic control on providers' perspectives, competencies and practice performance between an academic and four community hospital. The study received an IRB waiver of consent for the inclusion of subjects identified in the electronic health record. The consent of clinicians participating in study surveys is implied by agreeing to respond to surveys. It is hypothesized that the tool will increase providers' knowledge and decision making to manage dysglycemia allowing them to make better decisions about insulin administration. It is also hypothesized that clinical and economic outcomes will be better during the time alert-CDS is available. The anticipated success of our study builds upon a well-established multidisciplinary team of investigators strongly supported by leadership stakeholders in hospitals within a health system. The proposed study has the potential of establishing a new paradigm in the management of dysglycemia in hospitalized patients with a major positive impact on clinical and economic outcomes.

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 (Estimated)

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.
15732

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
      • Reading, Pennsylvania, United States, 19605

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Hospitalized adult (>18 years) patients at Penn State Health, Hershey Medical Center, St. Joseph's Hospital, Hampden Medical Center, Holy Spirit Medical Center, and Lancaster Medical Center
  • Ambulatory adult (>18 years) patients at Penn State Health, Hershey Medical Center, St. Joseph's Hospital, Hampden Medical Center, Holy Spirit Medical Center, and Lancaster Medical Center
  • Trigger of an alert or a disease management message

Exclusion Criteria:

  • Children (<18 years)

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: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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: Active Inpatient Diabetes Clinical Decision Support
The Active arm consists of participants treated during the "ON" phase of the GlucAlert-CDS tool. The tool operates through an automated process of rules embedded in the EMR recognizing hypoglycemia (established or impending); recurrent hyperglycemia (in type 1 and 2 DM, or stress hyperglycemia-SH); and inappropriate insulin use (sliding scales monotherapy if recurrent hyperglycemia in type 2 DM or SH, or any time in type 1 DM). If the tool's criteria are met, an alert in the EMR will notify the provider with the clinically recommended treatment.
Device: Active Electronic Medical Record Inpatient Diabetes Clinical Decision Support
This prospective intervention will be carried out over 36 months and encompass 12 alternating GlucAlert-CDS phases lasting 3 months each. Six active phases (ON period) and six inactive phases (OFF period) will represent 18 months of intervention and control respectively. GlucAlert-CDS recognizes gaps in care denoting the automatic process of subjects' identification and inclusion. During the ON period, gap in care events detected in patients' EMR will evoke alert messages and care recommendations for clinicians in real time for their consideration. These notifications are programmed to be delivered to primary inpatient providers in direct care of these hospitalized patients. During the OFF period, the program will record the gaps in care events detected, but alerts will be inactive for providers' viewing.
No Intervention: Inactive Inpatient Diabetes Clinical Decision Support
The Inactive arm consists of participants treated during the "OFF" phase of the GlucAlert-CDS Tool. Alerts will not be sent to provider's

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
Average hospital length of stay (LOS)
Time Frame: Duration of hospital admission, up to 3 months
Number of days in the hospital
Duration of hospital admission, up to 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of gap in care events
Time Frame: Duration of hospital admission, up to 3 months
Number of events recognized for: 1) Hyperglycemia: recurrent hyperglycemia [>= 180/dl at least twice] or severe hyperglycemia [>= 250 mg/dl at least once] 2) Hypoglycemia: established hypoglycemia [<= 70 mg/dl] or impending hypoglycemia [71-80 mg/dl] 3)Inappropriate insulin use: among type 2 diabetes and stress hyperglycemia patients [sliding scale monotherapy when recurrent hyperglycemia present] or among type 1 diabetes [sliding scale monotherapy any time].
Duration of hospital admission, up to 3 months
Glycemic control parameters - average glucose per day per admission
Time Frame: Duration of hospital admission, up to 3 months
Number of glucose values within the following categories: severe hypoglycemia (<= 40 mg/dl), moderate hypoglycemia (41-70 mg/dl), within normal limits but not desired (71-110 mg/dl), within target/less commonly recommended (111-140 mg/dl), within target (141-180 mg/dl), mild hyperglycemia (181-220 mg/dl), moderate hyperglycemia (221-300 mg/dl), severe hyperglycemia (>=301 mg/dl).
Duration of hospital admission, up to 3 months
Glycemic control parameters - glycemic variability
Time Frame: Duration of hospital admission, up to 3 months
Standard deviation
Duration of hospital admission, up to 3 months
Incidence of inpatient mortality
Time Frame: Duration of hospital admission, up to 3 months
Number of deceased patients
Duration of hospital admission, up to 3 months
Incidence of post-discharge mortality
Time Frame: Up to 3 months after discharge
Number of deceased patients
Up to 3 months after discharge
Frequency of severity of illness
Time Frame: Duration of hospital admission, up to 3 months
Number of cases during hospitalization: Diagnosis Related Group (DRG) SOI categories 1, 2, 3, and 4.
Duration of hospital admission, up to 3 months
Proportion of diabetes medication optimization at the transition of care
Time Frame: Duration of hospital admission, up to 3 months
Number of participants: Patients with A1c > 8% having their diabetes treatment adjusted upon discharge, defined as a preadmission diabetes treatment changed to include additional medications (insulin, oral or non-insulin injectable agents).
Duration of hospital admission, up to 3 months
Average reduction of glycohemoglobin level within 12 months of discharge
Time Frame: up to 12 months after being discharged from the hospital
Percent level reduction: Glycohemoglobin reduction in relation to level prior to admission among patients who continue to follow with the health system
up to 12 months after being discharged from the hospital
Frequency of hospital readmission
Time Frame: Up to 30 days after being discharged from the hospital
Number of admissions: Admission within 7, 14, and 30 days from discharge.
Up to 30 days after being discharged from the hospital
Frequency of Intensive Care unit (ICU) transfers
Time Frame: Duration of hospital admission, up to 3 months
Number of transfers: Refers to admission to ICU transferred from non-ICU units
Duration of hospital admission, up to 3 months
Cost of hospitalization
Time Frame: Duration of hospital admission, up to 3 months
Log-transformed amount of hospital submitted claims
Duration of hospital admission, up to 3 months
Frequency of post-hospitalization skilled care needed from home to more advanced care
Time Frame: Duration of hospital admission, up to 3 months
Number of discharges higher than preadmission level of care: defined as discharge to more advanced care than previous to admission such as a) Inpatient advanced care facilities, b) rehabilitation, c) nursing home care.
Duration of hospital admission, up to 3 months
Frequency of post-hospitalization skilled care needed
Time Frame: Duration of hospital admission, up to 3 months
Number of discharges higher than preadmission level of care: defined as discharge to more advanced care than previous to admission such as a) Inpatient advanced care facilities, b) rehabilitation, c) nursing home care.
Duration of hospital admission, up to 3 months
Frequency of utilization of consulting services resource
Time Frame: Duration of hospital admission, up to 3 months
Number of consults to diabetes services (endocrinology, diabetes education, hospitalists).
Duration of hospital admission, up to 3 months
Hospital revenue
Time Frame: Duration of hospital admission, up to 3 months
Number in category of DRG for expected reimbursement
Duration of hospital admission, up to 3 months
Glycemic control parameters - Glucose metrics
Time Frame: Duration of hospital admission, up to 3 months
Average glucose per admission, glucose range (Glucose value in mg/dl)
Duration of hospital admission, up to 3 months
Proportion of hospital-acquired infections
Time Frame: Duration of hospital admission, up to 3 months
Number of infections: 1)Hospital acquired pneumonia (HAP) 2)Catheter-associated urinary tract infections (CAUTI) 3)Clostridium difficile colitis 4)MRSA infections 5)Central Line associated Bloodstream Infection (CLABSI) 6)Bacteremia 7)Vancomycin Resistant Enterococcus 8)Skin and soft tissue infection (SSI) 9)Ventilator Acquired Pneumonia
Duration of hospital admission, up to 3 months
Proportion of surgical complications
Time Frame: Duration of hospital admission, up to 3 months
Number of complications: 1)Wound dehiscence 2)Seroma 3)Surgical site infection 4)Acute organ rejection 5)Ventral/Ruptured Hernia 6)Ileus
Duration of hospital admission, up to 3 months
Proportion of medical complications
Time Frame: Duration of hospital admission, up to 3 months
Number of complications: 1) Systemic inflammatory response syndrome SIRS 2)Sepsis 3)Severe sepsis 4)Septic shock 5)Decubitus ulcers 6)Deep venous thromboembolism 7)Pulmonary embolism 8)Diabetes ketoacidosis (DKA) 9)Hypoglycemia 10)Delirium 11)Encephalopathy 12)Mental status changes/altered mental status 13)Acute respiratory failure 14)Acute kidney injury/failure 15)Acute coronary syndrome/acute MI 16)Heart failure exacerbation 17)Stroke 18)Ventilatory support 19)Seizures 20)Coma 21)Irreversible neurologic injury 22)QT prolongation 23)Ventricular arrhythmias 24)Atrial arrhythmias 25)Sudden cardiac death 26)3)Fall occurred during hospitalization.
Duration of hospital admission, up to 3 months
Proportion of safety events
Time Frame: Duration of hospital admission, up to 3 months
Number of events: 1)Diabetes Ketoacidosis diagnosis in type 1 diabetes after sliding scale insulin monotherapy gap in care event notification 2)Severe hypoglycemia (glucose level <= 40 mg/dl) after any hypoglycemia or hyperglycemia gap in care event notification 3)Hyperosmolar hyperglycemia state in type 2 diabetes after sliding scale insulin monotherapy gap in care event notification
Duration of hospital admission, up to 3 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Provider's perspective
Time Frame: Up to 48 months
5-point Likert scale responses of 1)Usefulness of CDS managing glucose issues 2)Importance of CDS in hospital diabetes care 3)Support of the CDS in own decision making 4)Sense of work disruption caused by the CDS messages 5)Sense of notification fatigue caused by the CDS messages. Providers will respond with their level of agreement to each question on a 5-point scale (from 1 - Strongly Disagree to 5 - Strongly Agree).
Up to 48 months
Provider's knowledge
Time Frame: Up to 48 months
Multiple choice questions correct responses: Refers to question on contextual and biomedical knowledge
Up to 48 months
Provider's decision making
Time Frame: Up to 48 months
Proportion of correct responses: Clinical vignettes representing common clinical scenario of glucose management in the hospital
Up to 48 months
Provider's practice performance
Time Frame: Up to 48 months
Number of insulin treatment adjustments.
Up to 48 months

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.
Milton S. Hershey Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)

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: Ariana Pichardo-Lowden, MD, Penn State College of Medicine

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 (Actual)

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.
July 15, 2022

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.
October 16, 2025

Study Completion (Estimated)

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.
October 16, 2026

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).
June 15, 2022

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.
July 1, 2022

First Posted (Actual)

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.
July 7, 2022

Study Record Updates

Last Update Posted (Actual)

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.
May 14, 2026

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.
May 12, 2026

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.
August 1, 2025

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.
  • STUDY00012931/20607
  • 1R01DK130992-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This trial was granted prior to 2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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