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

Recruiting now

Conditions studied: Acute Pancreatitis

In brief

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.

Key facts

Study ID

NCT06401577

Run by

Milton S. Hershey Medical Center

People needed

800

Starts

2024-10-16

Expected to finish

2027-03-31

Last updated by the study team

2026-02-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of Southern California — Los Angeles, California, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Stanford University — Stanford, California, United States (enrolling)
• University of Florida — Gainesville, Florida, United States (enrolling)
• AdventHealth — Orlando, Florida, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• University of Illinois at Chicago — Chicago, Illinois, United States (enrolling)
• Indiana University — Indianapolis, Indiana, United States (enrolling)
• Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• Ohio State University — Columbus, Ohio, United States (enrolling)
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)
• Benaroya Research Institute — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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