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

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

The DREAM-ON study tests whether continuous glucose monitoring (CGM), which tracks blood sugar over time, can predict diabetes, prediabetes, and the need for insulin treatment. It is for people who recently had acute pancreatitis, a sudden swelling of the pancreas. The study also looks at how diabetes develops after pancreatitis and what type it is.

The DREAM-ON study will investigate whether continuous glucose monitoring (CGM) is useful to predict risk for developing diabetes mellitus (DM) and pre-diabetes mellitus (PDM), the need for insulin therapy among those who develop DM, and to determine whether CGM can provide insight into the pathophysiology and DM subtype among participants who have experienced an episode of acute pancreatitis (AP). Thus, the results of the DREAM-ON study could inform future clinical practice guidelines for the management AP as well as potentially extending the licensing authorization for CGM to include use in patients with pancreatogenic (Type 3c) DM.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You were diagnosed with acute pancreatitis within 90 days before joining.
  • You understand the study, can agree to take part, and can complete its forms, phone interviews, tests, and follow-up visits.

Who can't join

  • You have confirmed chronic pancreatitis (long-term damage to the pancreas), shown by certain calcium deposits on scans.
  • Your pancreatitis followed an ERCP procedure, which checks or treats pancreas and bile ducts, and your hospital stay was under 48 hours.
  • Before joining, you had pancreas surgery, removal of dead pancreas tissue, or drainage of fluid containing dead tissue.
  • You have a pancreas tumor, or a known or suspected fluid-filled tumor that widens the main pancreas duct or may have caused pancreatitis.
  • You took medicines not allowed by the study within 30 days before joining.
  • You have a serious illness that could affect safety or study results. Examples include an organ transplant, AIDS, cancer treatment in the past 12 months (except non-melanoma skin cancer), severe kidney disease or dialysis before pancreatitis, severe liver scarring with complications, or an illness expected to limit life to under 12 months.
  • You are known to be pregnant when joining, or you are in jail or prison.
  • You have another condition or factor that could make participation unsafe or make the study results less reliable.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (13)

CA

FL

IL

IN

MD

MN

OH

PA

WA