Investigating diabetes risk after acute pancreatitis using continuous glucose monitoring

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)

This study is testing if continuous glucose monitoring can help predict diabetes risk in people who have had acute pancreatitis.

Quick facts

• Study type: Observational
• Enrollment: 800 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Milton S. Hershey Medical Center (Academic / other)
• Locations: 13 sites (Los Angeles, California and 12 other locations)
• Trial ID: NCT06401577 on ClinicalTrials.gov

What this trial studies

The DREAM-ON study aims to explore the utility of continuous glucose monitoring (CGM) in predicting the development of diabetes mellitus (DM) and pre-diabetes mellitus (PDM) following an episode of acute pancreatitis (AP). It will assess whether CGM metrics can indicate the need for insulin therapy in those who develop DM and provide insights into the underlying mechanisms of diabetes related to pancreatitis. Participants will undergo blinded CGM at scheduled visits over a period of time to gather data on glucose levels and variability. The findings could lead to improved clinical guidelines for managing diabetes in patients with a history of acute pancreatitis.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with acute pancreatitis within the last 90 days.

Not a fit: Patients with chronic pancreatitis or those hospitalized for less than 48 hours due to post-endoscopic retrograde cholangiopancreatography (ERCP) acute pancreatitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the management of diabetes in patients who have experienced acute pancreatitis, potentially leading to better health outcomes.

How similar studies have performed: While the use of CGM in diabetes management is established, this specific application in the context of acute pancreatitis is relatively novel and has not been extensively tested in prior studies.

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

Where this trial is running

Los Angeles, California and 12 other locations

• University of Southern California — Los Angeles, California, United States (Recruiting)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
• Stanford University — Stanford, California, United States (Recruiting)
• University of Florida — Gainesville, Florida, United States (Recruiting)
• AdventHealth — Orlando, Florida, United States (Recruiting)
• Northwestern University — Chicago, Illinois, United States (Recruiting)
• University of Illinois at Chicago — Chicago, Illinois, United States (Recruiting)
• Indiana University — Indianapolis, Indiana, United States (Recruiting)
• Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
• University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
• Ohio State University — Columbus, Ohio, United States (Recruiting)
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
• Benaroya Research Institute — Seattle, Washington, United States (Recruiting)

Study contacts

• Principal investigator: Vernon M Chinchilli, PhD — Penn State College of Medicine
• Study coordinator: Ron Zimmerman, MPA

Conditions Acute Pancreatitis; Diabetes; Continuous Glucose Monitoring