Recruiting

Continuous Glucose MonitoringDiabetes RElated to Acute Pancreatitis and Its Mechanisms: Metabolic Outcomes Using Novel CGM Metrics

Sponsor:

Milton S. Hershey Medical Center

Code:

NCT06401577

Conditions

Acute Pancreatitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Dexcom Continuous Glucose Monitor (CGM)

Study Details

Brief summary:

The DREAM-ON study will investigate whether continuous glucose monitoring (CGM) is useful to predict risk for developing diabetes mellitus (DM) and pre-diabetes mellitus (PDM), the need for insulin therapy among those who develop DM, and to determine whether CGM can provide insight into the pathophysiology and DM subtype among participants who have experienced an episode of acute pancreatitis (AP). Thus, the results of the DREAM-ON study could inform future clinical practice guidelines for the management AP as well as potentially extending the licensing authorization for CGM to include use in patients with pancreatogenic (Type 3c) DM.

Conditions

Acute Pancreatitis

Study ID

NCT06401577

Start date

Oct 16, 2024

Status verified date

Feb, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Diagnosis of acute pancreatitis (AP) 0-90 days prior to enrollment
Participant fully understands and is able to participate in all aspects of the study, including providing informed consent, completion of case report forms, telephone interviews, metabolic testing, and planned longitudinal follow-ups

Exclusion Criteria:

Diagnosis of definite chronic pancreatitis (CP) at enrollment (see also study definitions) based on either of the following criteria met by computed tomography (CT) scan (including non-contrast enhanced) or Magnetic Resonance Imaging (MRI) or Magnetic Resonance Cholangiopancreatography (MRCP): (a) Parenchymal or ductal calcifications on CT scan (after excluding the possibility that calcifications are vascular); (b) Intraductal filling defects suggestive of calcifications on MRI and/or MRCP
Potential participants with post-endoscopic retrograde cholangiopancreatography (ERCP) AP who are hospitalized for <48 hours.
Prior (i.e., before enrollment) direct endoscopic necrosectomy of the pancreas or percutaneous necrosectomy or drainage of necrotic collection(s). Participants who require this during follow-up will remain in the study
Pancreatic tumors, including ductal adenocarcinoma, neuroendocrine tumors, and metastasis
Confirmed or suspected cystic tumor associated with main pancreatic duct dilation, or believed to be the cause of AP (in the site-PI's judgement).
Prior pancreatic surgery, including, but not limited to: distal pancreatectomy, pancreaticoduodenectomy, pancreatic necrosectomy, Frey procedure.
Use of disallowed concomitant medications within 30 days prior to enrollment. A comprehensive list of disallowed medications will be included and routinely updated in the study's Manual of Procedures
Severe systemic illness that in the judgement of the investigative team will confound outcome assessments of diabetes mellitus and immunological outcomes or pose additional risk for harms, including: history of solid organ transplant, acquired immunodeficiency syndrome (AIDS), active treatment for cancer (except non-melanoma skin cancer) within 12 months prior to enrollment, chronic kidney disease with estimated glomerular filtration rate (eGFR) < 30 or on dialysis prior to AP, and decompensated cirrhosis (based on imaging or biopsy), or any other medical condition that in the opinion of the site-PI carries a life expectancy of <12 months
Known pregnancy at the time of enrollment. Participants who become pregnant during follow-up will remain in the study, but may have modified study assessments for safety as detailed in the Manual of Procedures
Incarceration
Any other condition or factor that would compromise the participant's safety or the scientific integrity of the study

Study Design

Enrollment

800 participants

Anticipated

Interventions and Outcome Measures

Arms

CGM

Continuous Glucose Monitoring (CGM)

Interventions

Dexcom Continuous Glucose Monitor (CGM)

Dexcom Continuous Glucose Monitor which measures and records a participant's serum glucose level

Primary outcome measure

pre-diabetes mellitus following an episode of acute pancreatitis [ Time Frame: any time during the 36-month longitudinal follow-up period ]
diabetes mellitus following an episode of acute pancreatitis [ Time Frame: any time during the 36-month longitudinal follow-up period ]

Central Contacts and Locations

Central contacts

Ron Zimmerman, MPA

717-531-3851 rzimmerman1@pennstatehealth.psu.edu

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Contacts

Jessica Serna

323-409-6939 sernaj@usc.edu

Principal Investigator:

James L Buxbaum, MD

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Eleanor Chang

310-423-0747 eleanor.chang@cshs.org

Principal Investigator:

Mark O Goodarzi, MD, PhD

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Lorena Pineda

650-723-4519 ljpineda@stanford.edu

Principal Investigator:

Walter Park, MD

University of Florida

Recruiting

Gainesville, Florida, United States, 32610-0214

Contacts

Amber Bouton

352-273-9774 amber.bouton@surgery.ufl.edu

Principal Investigator:

Chris Forsmark, MD

AdventHealth

Recruiting

Orlando, Florida, United States, 32804

Contacts

Gina Mercouffer

407-303-7106 gina.mercouffer@adventhealth.com

Principal Investigator:

Richard E Pratley, MD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Christine Nelson

312-695-4513 c-ebert@northwestern.edu

Principal Investigator:

Rajesh N Keswani, MD, MS

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Haya Al Rashdan

312-413-0306 halras2@iuc.edu

Principal Investigator:

Cemal Yazici, MD, MSc

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Maureen Mullen-Montagano

317-274-7677 maamulle@iu.edu

Principal Investigator:

Evan L Fogel, MD

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Mahya Faghih

443-287-4680 mfaghih2@jhu.edu

Principal Investigator:

Vikesh Singh, MD, MSc

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55454

Contacts

Heather Hodgkins

612-626-5293 hodg0007@umn.edu

Principal Investigator:

Melena D Bellin, MD

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Zoe Krebs

614-685-6374 zoe.krebs@osumc.edu

Principal Investigator:

Phillip A Hart, MD

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Shari Reynolds

412-383-0570 reynoldss12@upmc.edu

Principal Investigator:

Dhiraj Yadav, MD, MPH

Benaroya Research Institute

Recruiting

Seattle, Washington, United States, 98101

Contacts

Kim Varner

206-341-8936 kvarner@benaroyaresearch.org

Principal Investigator:

Carla J Greenbaum, MD

More Information

Sponsor

Milton S. Hershey Medical Center

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Keywords

Diabetes
Continuous Glucose Monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Milton S. Hershey Medical Center on 2026-02-12.