An interventional study of Active Electronic Medical Record Inpatient Diabetes Clinical Decision Support in Hyperglycemia, Hyperglycemia Stress and Diabetes, sponsored by Milton S. Hershey Medical Center. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Health services research
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.
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.
800 studies on the registry are indexed under Hyperglycemia; 115 are open to participants now.
This study's planned enrollment of 15,732 is above the median of 50 across 620 interventional studies indexed under Hyperglycemia.
Browse Hyperglycemia studies →Milton S. Hershey Medical Center is the lead sponsor of 492 studies on the registry; 60 are open to participants now.
Of its 58 completed or terminated interventional studies of FDA-regulated products, 46 (79%) have results posted.
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Exclusion Criteria:
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
The Inactive arm consists of participants treated during the "OFF" phase of the GlucAlert-CDS Tool. Alerts will not be sent to provider's
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.
Average hospital length of stay (LOS)
Number of days in the hospital
Time frame: Duration of hospital admission, up to 3 months
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 \[sliding scale monotherapy any time\].
Time frame: Duration of hospital admission, up to 3 months
Glycemic control parameters - Glucose metrics
Average glucose per admission, glucose range (Glucose value in mg/dl)
Time frame: Duration of hospital admission, up to 3 months
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).
Time frame: Duration of hospital admission, up to 3 months
Glycemic control parameters - glycemic variability
Standard deviation
Time frame: Duration of hospital admission, up to 3 months
Incidence of inpatient mortality
Number of deceased patients
Time frame: Duration of hospital admission, up to 3 months
Incidence of post-discharge mortality
Number of deceased patients
Time frame: Up to 3 months after discharge
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
Time frame: Duration of hospital admission, up to 3 months
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
Time frame: Duration of hospital admission, up to 3 months
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.
Time frame: Duration of hospital admission, up to 3 months
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
Time frame: Duration of hospital admission, up to 3 months
Frequency of severity of illness
Number of cases during hospitalization: Diagnosis Related Group (DRG) SOI categories 1, 2, 3, and 4.
Time frame: Duration of hospital admission, up to 3 months
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).
Time frame: Duration of hospital admission, up to 3 months
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
Time frame: up to 12 months after being discharged from the hospital
Frequency of hospital readmission
Number of admissions: Admission within 7, 14, and 30 days from discharge.
Time frame: Up to 30 days after being discharged from the hospital
Frequency of Intensive Care unit (ICU) transfers
Number of transfers: Refers to admission to ICU transferred from non-ICU units
Time frame: Duration of hospital admission, up to 3 months
Cost of hospitalization
Log-transformed amount of hospital submitted claims
Time frame: Duration of hospital admission, up to 3 months
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.
Time frame: Duration of hospital admission, up to 3 months
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.
Time frame: Duration of hospital admission, up to 3 months
Frequency of utilization of consulting services resource
Number of consults to diabetes services (endocrinology, diabetes education, hospitalists).
Time frame: Duration of hospital admission, up to 3 months
Hospital revenue
Number in category of DRG for expected reimbursement
Time frame: Duration of hospital admission, up to 3 months
Provider's perspective
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).
Time frame: Up to 48 months
Provider's knowledge
Multiple choice questions correct responses: Refers to question on contextual and biomedical knowledge
Time frame: Up to 48 months
Provider's decision making
Proportion of correct responses: Clinical vignettes representing common clinical scenario of glucose management in the hospital
Time frame: Up to 48 months
Provider's practice performance
Number of insulin treatment adjustments.
Time frame: Up to 48 months
Plan to share: No — This trial was granted prior to 2023
No publications or documents are linked to this record.
Ran from Jul 2022 to primary completion in Oct 2025, 39 months.
Of 208 non-industry interventional studies with no phase under Hyperglycemia, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 27. This study's 39 months is above that.
Counting every sponsor, half of 225 studies reached it within 14 months; a quarter within 7 and three quarters within 27.
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