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

Launched by MILTON S. HERSHEY MEDICAL CENTER · May 2, 2024

Keywords

ClinConnect Summary

The DREAM-ON study is researching how continuous glucose monitoring (CGM) can help identify the risk of developing diabetes or pre-diabetes in patients who have recently experienced acute pancreatitis (AP). This study aims to find out if CGM can also predict who might need insulin treatment if they do develop diabetes and to better understand the different types of diabetes that can occur after an episode of AP. The findings from this study could help shape future guidelines for managing patients with acute pancreatitis and may expand the use of CGM in this context.

To participate in the study, individuals must have been diagnosed with acute pancreatitis within the last 90 days and be able to understand and complete all aspects of the study, including interviews and follow-ups. Unfortunately, those with certain conditions, such as chronic pancreatitis or pancreatic tumors, will not be eligible. Participants can expect to wear a CGM device and attend regular follow-up appointments, which will help researchers gather important information about their health over time.

Gender

ALL

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