Diabetes RElated to Acute Pancreatitis and Its Mechanisms: Metabolic Outcomes Using Novel CGM Metrics (DREAM-ON)

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Pancreatitis
• Intervention / Treatment: Device: Dexcom Continuous Glucose Monitor (CGM)

Detailed Description

The primary objective of the DREAM-ON study is to determine if continuous glucose monitoring (CGM) metrics can predict the incidence of prediabetes mellitus (PDM) and diabetes mellitus (DM) after an episode of acute pancreatitis (AP). Secondary objectives of the DREAM-ON study include determining if CGM metrics predict the need for insulin therapy in participants who develop diabetes mellitus after AP, and if CGM metrics correlate with measures of insulin secretion and insulin resistance.

The specific aims of the DREAM-ON study are as follows:

Aim 1: To test whether standard CGM metrics predict incident DM. The investigators will perform blinded CGM in DREAM-ON participants at their scheduled visits at months 3, 12, 24 and subsequent annual visits. The investigators will test whether standard CGM metrics (mean glucose, time in tight range 70-140, time in range 70-180, time above 180 mg/dL, time above 250 mg/dL and glucose CV) predict incident DM determined by fasting plasma glucose (FPG), HbA1c, oral glucose tolerance testing (OGTT) and clinical report.

Aim 2: To test whether CGM metrics predict need for insulin therapy in patients who develop DM after AP. From blinded CGM, we will test whether standard CGM metrics (mean glucose, time in tight range 70-140, time in range 70-180, time above 180 mg/dL, time above 250 mg/dL and glucose CV) as well as other indices of glucose variability, including mean amplitude of glycemic excursions (MAGE), predict need for long-term insulin therapy.

Aim 3: To determine whether CGM metrics correlate with measures of insulin secretion and insulin resistance. The investigators will test whether standard and advanced CGM metrics correlate with measures of insulin secretion and insulin resistance derived from the OGTT, the mixed meal tolerance test (MMT) and the frequently sampled intravenous glucose tolerance test (FSIGTT). The investigators also will test whether these metrics can be used as a surrogate to predict diabetes subtype (i.e., insulin deficient vs. insulin resistant).

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Ron Zimmerman, MPA; Phone Number: 717-531-3851; Email: rzimmerman1@pennstatehealth.psu.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
      • Contact: Eleanor Chang; Phone Number: 310-423-0747; Email: eleanor.chang@cshs.org
      • Principal Investigator: Mark O Goodarzi, MD, PhD
      • Principal Investigator: Stephen J Pandol, MD
    • Los Angeles, California, United States, 90033
      • Recruiting
      • University of Southern California
      • Contact: Jessica Serna; Phone Number: 323-409-6939; Email: sernaj@usc.edu
      • Principal Investigator: James L Buxbaum, MD
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University
      • Principal Investigator: Walter Park, MD
      • Principal Investigator: Marina Basina, MD
      • Contact: Lorena Pineda; Phone Number: 650-723-4519; Email: ljpineda@stanford.edu
  • Florida
    • Gainesville, Florida, United States, 32610-0214
      • Recruiting
      • University of Florida
      • Contact: Amber Bouton; Phone Number: 352-273-9774; Email: amber.bouton@surgery.ufl.edu
      • Principal Investigator: Chris Forsmark, MD
      • Principal Investigator: Steven J Hughes, MD
    • Orlando, Florida, United States, 32804
      • Recruiting
      • AdventHealth
      • Contact: Gina Mercouffer; Phone Number: 407-303-7106; Email: gina.mercouffer@adventhealth.com
      • Principal Investigator: Richard E Pratley, MD
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Contact: Christine Nelson; Phone Number: 312-695-4513; Email: c-ebert@northwestern.edu
      • Principal Investigator: Rajesh N Keswani, MD, MS
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois at Chicago
      • Principal Investigator: Cemal Yazici, MD, MSc
      • Principal Investigator: Brian Layden, MD
      • Contact: Haya Al Rashdan; Phone Number: 312-413-0306; Email: halras2@iuc.edu
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University
      • Contact: Maureen Mullen-Montagano; Phone Number: 317-274-7677; Email: maamulle@iu.edu
      • Principal Investigator: Evan L Fogel, MD
      • Principal Investigator: Carmella Evans-Molina, MD, PhD
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Recruiting
      • Johns Hopkins University
      • Contact: Mahya Faghih; Phone Number: 443-287-4680; Email: mfaghih2@jhu.edu
      • Principal Investigator: Vikesh Singh, MD, MSc
      • Principal Investigator: Zhaoli Sun, MD, PhD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • Recruiting
      • University of Minnesota
      • Contact: Heather Hodgkins; Phone Number: 612-626-5293; Email: hodg0007@umn.edu
      • Principal Investigator: Melena D Bellin, MD
      • Principal Investigator: Guru Trikudanathan, MD
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University
      • Principal Investigator: Phillip A Hart, MD
      • Contact: Zoe Krebs; Phone Number: 614-685-6374; Email: zoe.krebs@osumc.edu
      • Principal Investigator: Georgios Papachristou, MD, PhD
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh
      • Contact: Shari Reynolds; Phone Number: 412-383-0570; Email: reynoldss12@upmc.edu
      • Principal Investigator: Dhiraj Yadav, MD, MPH
      • Principal Investigator: Frederico GS Toledo, MD
  • Washington
    • Seattle, Washington, United States, 98101
      • Recruiting
      • Benaroya Research Institute
      • Contact: Kim Varner; Phone Number: 206-341-8936; Email: kvarner@benaroyaresearch.org
      • Principal Investigator: Carla J Greenbaum, MD
      • Principal Investigator: Richard A Kozarek, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized for acute pancreatitis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CGM; Continuous Glucose Monitoring (CGM)	Device: Dexcom Continuous Glucose Monitor (CGM); Dexcom Continuous Glucose Monitor which measures and records a participant's serum glucose level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pre-diabetes mellitus following an episode of acute pancreatitis	time to onset of pre-diabetes mellitus during the 36-month longitudinal follow-up period	any time during the 36-month longitudinal follow-up period
diabetes mellitus following an episode of acute pancreatitis	time to onset of diabetes mellitus during the 36-month longitudinal follow-up period	any time during the 36-month longitudinal follow-up period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
initiation of insulin therapy	time to onset of the initiation of insulin therapy of any type (basal, mixed, prandial, basal/bolus) for two or more weeks in a non-hospitalized setting after developing diabetes mellitus	any time during the 36-month longitudinal follow-up period
insulin secretion	insulin secretion during the oral glucose tolerance test (OGTT)	during the oral glucose tolerance test (OGTT) administered at 3, 12, 24, and 36 months
insulin sensitivity	insulin sensitivity during the oral glucose tolerance test (OGTT)	during the oral glucose tolerance test (OGTT) administered at 3, 12, 24, and 36 months
fasting glucose	fasting glucose during the mixed meal tolerance test (MMTT)	during the mixed meal tolerance test (MMTT) administered at 3, 12, 24, and 36 months
peak value glucose	peak value glucose during the mixed meal tolerance test (MMTT)	during the mixed meal tolerance test (MMTT) administered at 3, 12, 24, and 36 months
meal-stimulated insulin	meal-stimulated insulin during the mixed meal tolerance test (MMTT)	during the mixed meal tolerance test (MMTT) administered at 3, 12, 24, and 36 months
acute insulin response to glucose	acute insulin response to glucose during the frequently samples intravenous glucose tolerance test (FSIGTT)	during the frequently sampled intravenous glucose tolerance test (FSIGTT) administered at 3 and 12 months

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: Johns Hopkins University; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Northwestern University; University of Pittsburgh; University of Illinois at Chicago; University of Florida; University of Southern California; Stanford University; Ohio State University; University of Minnesota; Cedars-Sinai Medical Center; Indiana University; AdventHealth; Benaroya Research Institute
• Investigators: Principal Investigator: Vernon M Chinchilli, PhD, Penn State College of Medicine; Principal Investigator: Richard E Pratley, MD, AdventHealth

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: May 2, 2024
• First Submitted That Met QC Criteria: May 2, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Diabetes; Continuous Glucose Monitoring
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Pancreatic Diseases; Nutritional and Metabolic Diseases; Pancreatitis; Diabetes Mellitus
• Other Study ID Numbers: STUDY00015937; U01DK127384 (U.S. NIH Grant/Contract); R01DK138060 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data from final locked datasets will be made available to other researchers outside the DREAM-ON investigative team. The plan for data sharing incorporates a strategy that recognizes the importance of protecting participants' rights to individual privacy and is compliant with HIPAA regulations and NIH requirements (https://grants.nih.gov/grants/policy/data_sharing).
• IPD Sharing Time Frame: The data will be available one year after publication of the primary manuscript of the DREAM-ON manuscript. The data will be available indefinitely at the NIDDK Central Repository.
• IPD Sharing Access Criteria: Instructions for requesting data from the NIDDK Central Repository appear at the following web site: https://repository.niddk.nih.gov/pages/overall_instructions/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No