Investigating diabetes risk after acute pancreatitis using continuous glucose monitoring

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Vernon M Chinchilli, PhD — Penn State College of Medicine
• Study coordinator: Ron Zimmerman, MPA
• Email: rzimmerman1@pennstatehealth.psu.edu
• Phone: 717-531-3851

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Fecal microbiota transplant to prevent infections after late-phase severe acute pancreatitis

  This trial will test whether giving healthy donor gut bacteria (fecal microbiota transplantation) through a feeding tube in the late phase of moderately severe or severe acute pancreatitis can prevent infectious complications.

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• How often splanchnic vein clots occur in acute pancreatitis and whether they relate to disease severity

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• Fecal microbiota transplant for people with moderate to severe acute pancreatitis

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  Recruiting at 2 sites Changhai Hospital · Shanghai, Shanghai Municipality and 1 other locations · NCT07153809

• Blood markers to detect infected pancreatic necrosis

  We will test whether specific blood markers can help predict or diagnose infected pancreatic necrosis in adults with necrotizing pancreatitis.

  Recruiting University of Minnesota · Minneapolis, Minnesota · NCT06899087

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.