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HyperglycemiaNCT05447806

Diabetes Clinical Decision Support

A study testing Active Electronic Medical Record Inpatient Diabetes Clinical Decision Support in people with Hyperglycemia and Hyperglycemia Stress, run by Milton S. Hershey Medical Center at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hyperglycemia, Hyperglycemia Stress, Diabetes
What is being tested?
Active Electronic Medical Record Inpatient Diabetes Clinical Decision Support
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15,732 participants
Where
2 sitesUnited States
Study dates
15 Jul 2022to 16 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Children (<18 years)

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites, 2 recruiting
  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033

    Ariana Pichardo-Lowden, MD, 717-531-0003 ext. 281452, apichardolowden@pennstatehealth.psu.edu

    Recruiting
  • Penn State Health St. Joseph Medical Center

    Reading, Pennsylvania, 19605

    Franciss Quigley, MD, 610 378 2440, fquigley@pennstatehealth.psu.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Active Electronic Medical Record Inpatient Diabetes Clinical Decision Support
Keywords
Clinical Decision Support, Electronic Medical Records, Health Systems Science, Hospital Management
Medical subject headings
Hyperglycemia, Diabetes Mellitus, Prediabetic State, Hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active Electronic Medical Record Inpatient Diabetes Clinical Decision SupportDevice

    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.

Study groups in NCT05447806
Study groupRoleWhat they receive
Active Inpatient Diabetes Clinical Decision SupportExperimentalThe 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.
Receives: Device: Active Electronic Medical Record Inpatient Diabetes Clinical Decision Support
Inactive Inpatient Diabetes Clinical Decision SupportNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Average hospital length of stay (LOS)

    Number of days in the hospital

    Measured: Duration of hospital admission, up to 3 months

Secondary outcomes (20)
  1. Proportion of gap in care events

    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].

    Measured: Duration of hospital admission, up to 3 months

  2. Glycemic control parameters - Glucose metrics

    Average glucose per admission, glucose range (Glucose value in mg/dl)

    Measured: Duration of hospital admission, up to 3 months

  3. Glycemic control parameters - average glucose per day per admission

    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).

    Measured: Duration of hospital admission, up to 3 months

  4. Glycemic control parameters - glycemic variability

    Standard deviation

    Measured: Duration of hospital admission, up to 3 months

  5. Incidence of inpatient mortality

    Number of deceased patients

    Measured: Duration of hospital admission, up to 3 months

  6. Incidence of post-discharge mortality

    Number of deceased patients

    Measured: Up to 3 months after discharge

  7. Proportion of hospital-acquired infections

    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

    Measured: Duration of hospital admission, up to 3 months

  8. Proportion of surgical complications

    Number of complications: 1)Wound dehiscence 2)Seroma 3)Surgical site infection 4)Acute organ rejection 5)Ventral/Ruptured Hernia 6)Ileus

    Measured: Duration of hospital admission, up to 3 months

  9. Proportion of medical complications

    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.

    Measured: Duration of hospital admission, up to 3 months

  10. Proportion of safety events

    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

    Measured: Duration of hospital admission, up to 3 months

  11. Frequency of severity of illness

    Number of cases during hospitalization: Diagnosis Related Group (DRG) SOI categories 1, 2, 3, and 4.

    Measured: Duration of hospital admission, up to 3 months

  12. Proportion of diabetes medication optimization at the transition of care

    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).

    Measured: Duration of hospital admission, up to 3 months

  13. Average reduction of glycohemoglobin level within 12 months of discharge

    Percent level reduction: Glycohemoglobin reduction in relation to level prior to admission among patients who continue to follow with the health system

    Measured: up to 12 months after being discharged from the hospital

  14. Frequency of hospital readmission

    Number of admissions: Admission within 7, 14, and 30 days from discharge.

    Measured: Up to 30 days after being discharged from the hospital

  15. Frequency of Intensive Care unit (ICU) transfers

    Number of transfers: Refers to admission to ICU transferred from non-ICU units

    Measured: Duration of hospital admission, up to 3 months

  16. Cost of hospitalization

    Log-transformed amount of hospital submitted claims

    Measured: Duration of hospital admission, up to 3 months

  17. Frequency of post-hospitalization skilled care needed from home to more advanced care

    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.

    Measured: Duration of hospital admission, up to 3 months

  18. Frequency of post-hospitalization skilled care needed

    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.

    Measured: Duration of hospital admission, up to 3 months

  19. Frequency of utilization of consulting services resource

    Number of consults to diabetes services (endocrinology, diabetes education, hospitalists).

    Measured: Duration of hospital admission, up to 3 months

  20. Hospital revenue

    Number in category of DRG for expected reimbursement

    Measured: Duration of hospital admission, up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2022
  2. Study start15 Jul 2022
  3. Primary completion16 Oct 2025
  4. Study completion16 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
This prospective quasi-experiment will use an interrupted time series analysis to determine the impact of our novel glucose management CDS tool on the care of adult hospitalized patients outside of intensive care units in an academic and four community hospitals. The tool will be intermittently active in the EMR hospital-wide every 3 months for 36-months to enable an intervention (active) and a control (inactive) group of 18 months each in each hospital.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
15,732 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05447806
Sponsor's protocol ID
STUDY00012931/20607
Other IDs
1R01DK130992-01
Status last verified
Aug 2025
First submitted
15 Jun 2022
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: This trial was granted prior to 2023

Questions about this trial

What is this clinical trial studying?

A study testing Active Electronic Medical Record Inpatient Diabetes Clinical Decision Support in people with Hyperglycemia and Hyperglycemia Stress, run by Milton S. Hershey Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ariana Pichardo-Lowden, MD (7175310003 ext. 281452, apichardolowden@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average hospital length of stay (LOS) (time frame: Duration of hospital admission, up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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Diabetes Clinical Decision Support (NCT05447806) | AzTrials