Diabetes RElated to Acute Pancreatitis and Its Mechanisms: Metabolic Outcomes Using Novel CGM Metrics
NCT ID: NCT06401577
Last Updated: 2026-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
800 participants
OBSERVATIONAL
2024-10-16
2027-03-31
Brief Summary
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Detailed Description
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The specific aims of the DREAM-ON study are as follows:
Aim 1: To test whether standard CGM metrics predict incident DM. The investigators will perform blinded CGM in DREAM-ON participants at their scheduled visits at months 3, 12, 24 and subsequent annual visits. The investigators will test whether standard CGM metrics (mean glucose, time in tight range 70-140, time in range 70-180, time above 180 mg/dL, time above 250 mg/dL and glucose CV) predict incident DM determined by fasting plasma glucose (FPG), HbA1c, oral glucose tolerance testing (OGTT) and clinical report.
Aim 2: To test whether CGM metrics predict need for insulin therapy in patients who develop DM after AP. From blinded CGM, we will test whether standard CGM metrics (mean glucose, time in tight range 70-140, time in range 70-180, time above 180 mg/dL, time above 250 mg/dL and glucose CV) as well as other indices of glucose variability, including mean amplitude of glycemic excursions (MAGE), predict need for long-term insulin therapy.
Aim 3: To determine whether CGM metrics correlate with measures of insulin secretion and insulin resistance. The investigators will test whether standard and advanced CGM metrics correlate with measures of insulin secretion and insulin resistance derived from the OGTT, the mixed meal tolerance test (MMT) and the frequently sampled intravenous glucose tolerance test (FSIGTT). The investigators also will test whether these metrics can be used as a surrogate to predict diabetes subtype (i.e., insulin deficient vs. insulin resistant).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CGM
Continuous Glucose Monitoring (CGM)
Dexcom Continuous Glucose Monitor (CGM)
Dexcom Continuous Glucose Monitor which measures and records a participant's serum glucose level
Interventions
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Dexcom Continuous Glucose Monitor (CGM)
Dexcom Continuous Glucose Monitor which measures and records a participant's serum glucose level
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Benaroya Research Institute
OTHER
Cedars-Sinai Medical Center
OTHER
University of Southern California
OTHER
Indiana University
OTHER
Johns Hopkins University
OTHER
Ohio State University
OTHER
Stanford University
OTHER
University of Florida
OTHER
AdventHealth
OTHER
University of Illinois at Chicago
OTHER
Northwestern University
OTHER
University of Minnesota
OTHER
University of Pittsburgh
OTHER
Milton S. Hershey Medical Center
OTHER
Responsible Party
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Vernon Michael Chinchilli
Distinguished Professor
Principal Investigators
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Vernon M Chinchilli, PhD
Role: PRINCIPAL_INVESTIGATOR
Penn State College of Medicine
Richard E Pratley, MD
Role: PRINCIPAL_INVESTIGATOR
AdventHealth
Locations
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University of Southern California
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Stanford University
Stanford, California, United States
University of Florida
Gainesville, Florida, United States
AdventHealth
Orlando, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Minnesota
Minneapolis, Minnesota, United States
Ohio State University
Columbus, Ohio, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Benaroya Research Institute
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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