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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorMilton S. Hershey Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Dexcom Continuous Glucose Monitor (CGM)

Treatment groups

800 Participants
are divided into 1 treatment group

Sponsors and collaborators

Milton S. Hershey Medical Center

Lead sponsor

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