Diabetes RElated to Acute Pancreatitis and Its Mechanisms: Metabolic Outcomes Using Novel CGM Metrics

NCT06401577 | Recruiting DMC FDA Device

• 3 other identifiers: STUDY00015937R01DK138060U01DK127384
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 13

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

Keywords

Diabetes; Continuous Glucose Monitoring

Outcome Measures

Primary Outcomes (2)

• pre-diabetes mellitus following an episode of acute pancreatitis

  time to onset of pre-diabetes mellitus during the 36-month longitudinal follow-up period

  any time during the 36-month longitudinal follow-up period

• diabetes mellitus following an episode of acute pancreatitis

  time to onset of diabetes mellitus during the 36-month longitudinal follow-up period

  any time during the 36-month longitudinal follow-up period

Secondary Outcomes (7)

• initiation of insulin therapy

  any time during the 36-month longitudinal follow-up period

• insulin secretion

  during the oral glucose tolerance test (OGTT) administered at 3, 12, 24, and 36 months

• insulin sensitivity

  during the oral glucose tolerance test (OGTT) administered at 3, 12, 24, and 36 months

• fasting glucose

  during the mixed meal tolerance test (MMTT) administered at 3, 12, 24, and 36 months

• peak value glucose

  during the mixed meal tolerance test (MMTT) administered at 3, 12, 24, and 36 months

Study Arms (1)

CGM

Continuous Glucose Monitoring (CGM)

Device: Dexcom Continuous Glucose Monitor (CGM)

Interventions

Dexcom Continuous Glucose Monitor (CGM) DEVICE

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

CGM

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized for acute pancreatitis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Benaroya Research Institute: collaborator
• Cedars-Sinai Medical Center: collaborator
• University of Southern California: collaborator
• Indiana University: collaborator
• Johns Hopkins University: collaborator
• Ohio State University: collaborator
• Stanford University: collaborator
• University of Florida: collaborator
• AdventHealth: collaborator
• University of Illinois at Chicago: collaborator
• Northwestern University: collaborator
• University of Minnesota: collaborator
• University of Pittsburgh: collaborator

Study Sites (13)

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Stanford University

Stanford, California, 94305, United States

RECRUITING

University of Florida

Gainesville, Florida, 32610-0214, United States

RECRUITING

AdventHealth

Orlando, Florida, 32804, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21205, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55454, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Benaroya Research Institute

Seattle, Washington, 98101, United States

RECRUITING

MeSH Terms

Conditions

Pancreatitis; Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Vernon M Chinchilli, PhD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

• Richard E Pratley, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ron Zimmerman, MPA

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 6, 2024
• Study Start: October 16, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available one year after publication of the primary manuscript of the DREAM-ON manuscript. The data will be available indefinitely at the NIDDK Central Repository.
• Access Criteria: Instructions for requesting data from the NIDDK Central Repository appear at the following web site: https://repository.niddk.nih.gov/pages/overall\ instructions/

Locations

US (13)