Acute PancreatitisDREAM-ONNCT06401577
Diabetes RElated to Acute Pancreatitis and Its Mechanisms: Metabolic Outcomes Using Novel CGM Metrics
An observational study of Acute Pancreatitis, run by Milton S. Hershey Medical Center at 13 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Dexcom Continuous Glucose Monitor (CGM)
- Type of treatment
- Medical device
- How many people
- 800 participants
- Where
- 13 sitesUnited States
- Study dates
- 16 Oct 2024to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized for acute pancreatitis
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21205
Mahya Faghih, 443-287-4680, mfaghih2@jhu.edu
Vikesh Singh, MD, MSc
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Christine Nelson, 312-695-4513, c-ebert@northwestern.edu
Rajesh N Keswani, MD, MS
- Recruiting
University of Illinois at Chicago
Chicago, Illinois, 60612
Haya Al Rashdan, 312-413-0306, halras2@iuc.edu
Cemal Yazici, MD, MSc
- Recruiting
Ohio State University
Columbus, Ohio, 43210
Zoe Krebs, 614-685-6374, zoe.krebs@osumc.edu
Phillip A Hart, MD
- Recruiting
University of Florida
Gainesville, Florida, 32610-0214
Amber Bouton, 352-273-9774, amber.bouton@surgery.ufl.edu
Chris Forsmark, MD
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Maureen Mullen-Montagano, 317-274-7677, maamulle@iu.edu
Evan L Fogel, MD
- Recruiting
University of Southern California
Los Angeles, California, 90033
Jessica Serna, 323-409-6939, sernaj@usc.edu
James L Buxbaum, MD
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Eleanor Chang, 310-423-0747, eleanor.chang@cshs.org
Mark O Goodarzi, MD, PhD
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55454
Heather Hodgkins, 612-626-5293, hodg0007@umn.edu
Melena D Bellin, MD
- Recruiting
AdventHealth
Orlando, Florida, 32804
Gina Mercouffer, 407-303-7106, gina.mercouffer@adventhealth.com
Richard E Pratley, MD
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Shari Reynolds, 412-383-0570, reynoldss12@upmc.edu
Dhiraj Yadav, MD, MPH
- Recruiting
Benaroya Research Institute
Seattle, Washington, 98101
Kim Varner, 206-341-8936, kvarner@benaroyaresearch.org
Carla J Greenbaum, MD
- Recruiting
Stanford University
Stanford, California, 94305
Lorena Pineda, 650-723-4519, ljpineda@stanford.edu
Walter Park, MD
About this study
Official title: 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.
Read the 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).
- Conditions
- Acute Pancreatitis
- Being tested
- Dexcom Continuous Glucose Monitor (CGM)
- Keywords
- Diabetes, Continuous Glucose Monitoring
- Medical subject headings
- Pancreatitis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom Continuous Glucose Monitor (CGM)Device
Dexcom Continuous Glucose Monitor which measures and records a participant's serum glucose level
| Study group | Role | What they receive |
|---|---|---|
| CGM | Continuous Glucose Monitoring (CGM) Receives: Device: Dexcom Continuous Glucose Monitor (CGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pre-diabetes mellitus following an episode of acute pancreatitis
time to onset of pre-diabetes mellitus during the 36-month longitudinal follow-up period
Measured: 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
Measured: any time during the 36-month longitudinal follow-up period
Secondary outcomes (7)
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
Measured: any time during the 36-month longitudinal follow-up period
insulin secretion
insulin secretion during the oral glucose tolerance test (OGTT)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: during the frequently sampled intravenous glucose tolerance test (FSIGTT) administered at 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start16 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Benaroya Research Institute, Cedars-Sinai Medical Center, University of Southern California, Indiana University, Johns Hopkins University, Ohio State University, Stanford University, University of Florida, AdventHealth, University of Illinois Chicago, Northwestern University, University of Minnesota, University of Pittsburgh
- Responsible party
- Principal investigator, Vernon Michael Chinchilli, Milton S. Hershey Medical Center
- Investigators
- Vernon M Chinchilli, PhD, Principal investigator, Penn State College of MedicineRichard E Pratley, MD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401577
- Sponsor's protocol ID
- STUDY00015937
- Other IDs
- R01DK138060, U01DK127384
- Acronym
- DREAM-ON
- Status last verified
- Feb 2026
- First submitted
- 2 May 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06401577
- Acronym / sponsor ID
- DREAM-ON / STUDY00015937
- Conditions
- Acute Pancreatitis
- Keywords
- Diabetes, Continuous Glucose Monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Benaroya Research Institute, Cedars-Sinai Medical Center, University of Southern California, Indiana University, Johns Hopkins University, Ohio State University, Stanford University, University of Florida, AdventHealth, University of Illinois Chicago, Northwestern University, University of Minnesota, University of Pittsburgh
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CGM | – | Device: Dexcom Continuous Glucose Monitor (CGM)Continuous Glucose Monitoring (CGM) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized for acute pancreatitis
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexcom Continuous Glucose Monitor (CGM)Dexcom Continuous Glucose Monitor which measures and records a participant's serum glucose level | Device | CGM |
Primary outcome
pre-diabetes mellitus following an episode of acute pancreatitis
Time frame: any time during the 36-month longitudinal follow-up period
time to onset of pre-diabetes mellitus during the 36-month longitudinal follow-up period
diabetes mellitus following an episode of acute pancreatitis
Time frame: any time during the 36-month longitudinal follow-up period
time to onset of diabetes mellitus during the 36-month longitudinal follow-up period
7 secondary outcomes
initiation of insulin therapy
Time frame: any time during the 36-month longitudinal follow-up period
insulin secretion
Time frame: during the oral glucose tolerance test (OGTT) administered at 3, 12, 24, and 36 months
insulin sensitivity
Time frame: during the oral glucose tolerance test (OGTT) administered at 3, 12, 24, and 36 months
fasting glucose
Time frame: during the mixed meal tolerance test (MMTT) administered at 3, 12, 24, and 36 months
peak value glucose
Time frame: during the mixed meal tolerance test (MMTT) administered at 3, 12, 24, and 36 months
meal-stimulated insulin
Time frame: during the mixed meal tolerance test (MMTT) administered at 3, 12, 24, and 36 months
acute insulin response to glucose
Time frame: during the frequently sampled intravenous glucose tolerance test (FSIGTT) administered at 3 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vernon M Chinchilli, PhD principal investigator
Penn State College of Medicine
Richard E Pratley, MD principal investigator
AdventHealth
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis, run by Milton S. Hershey Medical Center at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ron Zimmerman, MPA (717-531-3851, rzimmerman1@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pre-diabetes mellitus following an episode of acute pancreatitis (time frame: any time during the 36-month longitudinal follow-up period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.