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

NCT06401577 · Milton S. Hershey Medical Center
In plain English

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Official title
Diabetes RElated to Acute Pancreatitis and Its Mechanisms: Metabolic Outcomes Using Novel CGM Metrics (DREAM-ON) - An Observational Cohort Study From the Type 1 Diabetes in Acute Pancreatitis Consortium (T1DAPC)
About this study
The primary objective of the DREAM-ON study is to determine if continuous glucose monitoring (CGM) metrics can predict the incidence of prediabetes mellitus (PDM) and diabetes mellitus (DM) after an episode of acute pancreatitis (AP). Secondary objectives of the DREAM-ON study include determining if CGM metrics predict the need for insulin therapy in participants who develop diabetes mellitus after AP, and if CGM metrics correlate with measures of insulin secretion and insulin resistance. 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).
Eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Study design
Enrollment target: 800 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-10-16
Estimated completion: 2027-03-31
Last updated: 2026-02-12
Interventions
Device: Dexcom Continuous Glucose Monitor (CGM)
Primary outcomes
  • pre-diabetes mellitus following an episode of acute pancreatitis (any time during the 36-month longitudinal follow-up period)
  • diabetes mellitus following an episode of acute pancreatitis (any time during the 36-month longitudinal follow-up period)
Sponsor
Milton S. Hershey Medical Center · other
With: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Benaroya Research Institute, Cedars-Sinai Medical Center, University of Southern California, Indiana University, Johns Hopkins University, Ohio State University, Stanford University, University of Florida, AdventHealth, University of Illinois at Chicago, Northwestern University, University of Minnesota, University of Pittsburgh
Contacts & investigators
ContactRon Zimmerman, MPA · contact · rzimmerman1@pennstatehealth.psu.edu · 717-531-3851
InvestigatorVernon M Chinchilli, PhD · principal_investigator, Penn State College of Medicine
InvestigatorRichard E Pratley, MD · principal_investigator, AdventHealth
All locations (13)
University of Southern CaliforniaRecruiting
Los Angeles, California, United States
Cedars-Sinai Medical CenterRecruiting
Los Angeles, California, United States
Stanford UniversityRecruiting
Stanford, California, United States
University of FloridaRecruiting
Gainesville, Florida, United States
AdventHealthRecruiting
Orlando, Florida, United States
Northwestern UniversityRecruiting
Chicago, Illinois, United States
University of Illinois at ChicagoRecruiting
Chicago, Illinois, United States
Indiana UniversityRecruiting
Indianapolis, Indiana, United States
Johns Hopkins UniversityRecruiting
Baltimore, Maryland, United States
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States
Ohio State UniversityRecruiting
Columbus, Ohio, United States
University of PittsburghRecruiting
Pittsburgh, Pennsylvania, United States
Benaroya Research InstituteRecruiting
Seattle, Washington, United States