Actively Recruiting
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)
Led by Milton S. Hershey Medical Center · Updated on 2026-02-12
800
Participants Needed
13
Research Sites
12 weeks
Total Duration
On this page
Sponsors
M
Milton S. Hershey Medical Center
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how continuous glucose monitoring (CGM) can help predict the risk of developing diabetes mellitus (DM) and prediabetes mellitus (PDM) following an episode of acute pancreatitis (AP). The study also aims to assess whether CGM can provide insights into the need for insulin therapy in those who develop diabetes after AP and explore the underlying mechanisms and diabetes subtypes related to this condition. This observational cohort study is part of the Type 1 Diabetes in Acute Pancreatitis Consortium (T1DAPC). Participants will undergo blinded CGM at scheduled visits at 3, 12, 24 months, and annually thereafter to collect glucose data. The study will analyze standard CGM metrics such as mean glucose levels, time spent in specific glucose ranges, and glucose variability to predict diabetes onset and the need for insulin treatment. Additional tests like oral glucose tolerance tests (OGTT), mixed meal tolerance tests (MMT), and frequently sampled intravenous glucose tolerance tests (FSIGTT) will be performed to evaluate insulin secretion and resistance. During the study, participants will be assessed through metabolic tests and case report forms, including telephone interviews and longitudinal follow-ups over a 36-month period. Researchers will measure the incidence of prediabetes and diabetes, insulin therapy initiation, and glucose-related metabolic parameters at various time points. The study will provide detailed monitoring to understand glucose patterns and diabetes development after AP, with safety and scientific integrity maintained throughout.
CONDITIONS
Brief Title
Diabetes RElated to Acute Pancreatitis and Its Mechanisms: Metabolic Outcomes Using Novel CGM Metrics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of acute pancreatitis within 0 to 90 days before enrollment
- Ability to understand and participate in all study aspects, including informed consent, case report forms, telephone interviews, metabolic testing, and longitudinal follow-ups
- Age between 18 and 75 years at enrollment
You will not qualify if you...
- Definite chronic pancreatitis diagnosed by CT scan or MRI/MRCP showing parenchymal or ductal calcifications
- Hospitalization for less than 48 hours due to post-endoscopic retrograde cholangiopancreatography acute pancreatitis
- Prior direct endoscopic necrosectomy or percutaneous necrosectomy or drainage before enrollment
- Presence of pancreatic tumors, including ductal adenocarcinoma, neuroendocrine tumors, or metastasis
- Confirmed or suspected cystic tumor causing pancreatic duct dilation or acute pancreatitis
- Previous pancreatic surgery such as distal pancreatectomy, pancreaticoduodenectomy, pancreatic necrosectomy, or Frey procedure
- Use of disallowed medications within 30 days before enrollment
- Severe systemic illness including history of solid organ transplant, AIDS, active cancer treatment within 12 months, chronic kidney disease with eGFR less than 30 or dialysis, decompensated cirrhosis, or life expectancy less than 12 months
- Known pregnancy at enrollment
- Incarceration
- Any condition compromising participant safety or study integrity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months
Participants undergo continuous glucose monitoring using a Dexcom Continuous Glucose Monitor (CGM) at scheduled visits to track glucose levels and metabolic outcomes after acute pancreatitis.
Visits at 3, 12, 24, and 36 months with CGM measurements and metabolic testing
Trial Site Locations
Total: 13 locations
1
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
3
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
4
University of Florida
Gainesville, Florida, United States, 32610-0214
Actively Recruiting
5
AdventHealth
Orlando, Florida, United States, 32804
Actively Recruiting
6
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
7
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
8
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
9
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Actively Recruiting
10
University of Minnesota
Minneapolis, Minnesota, United States, 55454
Actively Recruiting
11
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
12
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
13
Benaroya Research Institute
Seattle, Washington, United States, 98101
Actively Recruiting
Research Team
R
Ron Zimmerman, MPA
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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