Diabetes Clinical Decision Support

NCT05447806 | Recruiting FDA Device

• 2 other identifiers: STUDY00012931/206071R01DK130992-01
• Study Type: interventional
• Target: 15,732
• Locations: 1 country
• Sites: 2

Brief 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. The study also evaluates the perspectives of providers regarding the tool's usefulness on disease management support, knowledge, and practice performance.

Conditions

Hyperglycemia; Hyperglycemia Stress; Diabetes; PreDiabetes; Hypoglycemia

Keywords

Clinical Decision Support; Electronic Medical Records; Health Systems Science; Hospital Management

Outcome Measures

Primary Outcomes (1)

• Average hospital length of stay (LOS)

  Number of days in the hospital

  Duration of hospital admission, up to 6 weeks

Secondary Outcomes (20)

• Proportion of gap in care events

  Duration of hospital admission, up to 3 months

• Glycemic control parameters - average glucose per admission

  Duration of hospital admission, up to 3 months

• Glycemic control parameters - average glucose per day per admission

  Duration of hospital admission, up to 3 months

• Glycemic control parameters - glycemic variability

  Duration of hospital admission, up to 3 months

• Incidence of inpatient mortality

  Duration of hospital admission, up to 3 months

Other Outcomes (4)

• Provider's perspective

  Up to 24 months

• Provider's knowledge

  Up to 24 months

• Provider's decision making

  Up to 24 months

Study Arms (2)

Active Inpatient Diabetes Clinical Decision Support

EXPERIMENTAL

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

Inactive Inpatient Diabetes Clinical Decision Support

NO INTERVENTION

The Inactive arm consists of participants treated during the "OFF" phase of the GlucAlert-CDS Tool. Alerts will not be sent to provider's

Interventions

Active Electronic Medical Record Inpatient Diabetes Clinical Decision Support DEVICE

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.

Active Inpatient Diabetes Clinical Decision Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Children (\<18 years)

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

Penn State Health St. Joseph Medical Center

Reading, Pennsylvania, 19605, United States

RECRUITING

MeSH Terms

Conditions

Hyperglycemia; Diabetes Mellitus; Prediabetic State; Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ariana Pichardo-Lowden, MD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ariana Pichardo-Lowden, MD

CONTACT

7175310003; apichardolowden@pennstatehealth.psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study is single-blinded. Participants will be masked from the intervention due to the GlucAlert CDS tool only being viewed by physicians. Investigators will remain unblinded and know when the tool is turned "On" or "Off." The outcomes statisticians and assessors will analyze deidentified data and remain blinded for their analysis.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Medicine

Model Details: 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 a community hospital. The tool will be intermittently active in the EMR hospital-wide every 3 months during 36-months to enable an intervention (active) and a control (inactive) group of 18 months each in each hospital.

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: July 7, 2022
• Study Start: July 15, 2022
• Primary Completion: January 14, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

US (2)