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
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