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

Acute Pancreatitis Clinical Trial

— DREAM-ON  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06401577
• Other study ID #: STUDY00015937
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: March 31, 2027

Study information

• Verified date: May 2024
• Source: Milton S. Hershey Medical Center
• Contact: Melissa A Butt, DrPH
• Phone: 717-531-1258
• Email: mbutt1[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: March 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

Device:
• Dexcom Continuous Glucose Monitor (CGM)
Dexcom Continuous Glucose Monitor which measures and records a participant's serum glucose level

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Northwestern University	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Ohio State University	Columbus	Ohio
United States	University of Florida	Gainesville	Florida
United States	Indiana University	Indianapolis	Indiana
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	University of Minnesota	Minneapolis	Minnesota
United States	AdventHealth	Orlando	Florida
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Benaroya Research Institute	Seattle	Washington
United States	Stanford University	Stanford	California

Sponsors (15)

Lead Sponsor

Collaborator

Milton S. Hershey Medical Center

AdventHealth, Benaroya Research Institute, Cedars-Sinai Medical Center, Indiana University, Johns Hopkins University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Northwestern University, Ohio State University, Stanford University, University of Florida, University of Illinois at Chicago, University of Minnesota, University of Pittsburgh, University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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