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.
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
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
Patients hospitalized for acute pancreatitis
Cohort
Prospective
Dexcom Continuous Glucose Monitor (CGM)
DeviceDexcom Continuous Glucose Monitor which measures and records a participant's serum glucose level
pre-diabetes mellitus following an episode of acute pancreatitis
time to onset of pre-diabetes mellitus 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
initiation of insulin therapy
time to onset of the initiation of insulin therapy of any type (basal, mixed, prandial, basal/bolus) for two or more weeks in a non-hospitalized setting after developing diabetes mellitus
insulin secretion
insulin secretion during the oral glucose tolerance test (OGTT)
insulin sensitivity
insulin sensitivity during the oral glucose tolerance test (OGTT)
fasting glucose
fasting glucose during the mixed meal tolerance test (MMTT)
Click on the lead sponsor to view all of their trials.
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
