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

Last updated: February 7, 2025
Sponsor: Milton S. Hershey Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pancreatitis

Treatment

Dexcom Continuous Glucose Monitor (CGM)

Clinical Study ID

NCT06401577
STUDY00015937
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 thestudy, including providing informed consent, completion of case report forms,telephone interviews, metabolic testing, and planned longitudinal follow-ups

Exclusion

Exclusion Criteria:

  • Diagnosis of definite chronic pancreatitis (CP) at enrollment (see also studydefinitions) based on either of the following criteria met by computed tomography (CT) scan (including non-contrast enhanced) or Magnetic Resonance Imaging (MRI) orMagnetic Resonance Cholangiopancreatography (MRCP): (a) Parenchymal or ductalcalcifications on CT scan (after excluding the possibility that calcifications arevascular); (b) Intraductal filling defects suggestive of calcifications on MRIand/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 orpercutaneous necrosectomy or drainage of necrotic collection(s). Participants whorequire this during follow-up will remain in the study

  • Pancreatic tumors, including ductal adenocarcinoma, neuroendocrine tumors, andmetastasis

  • 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. Acomprehensive list of disallowed medications will be included and routinely updatedin the study's Manual of Procedures

  • Severe systemic illness that in the judgement of the investigative team willconfound outcome assessments of diabetes mellitus and immunological outcomes or poseadditional risk for harms, including: history of solid organ transplant, acquiredimmunodeficiency syndrome (AIDS), active treatment for cancer (except non-melanomaskin cancer) within 12 months prior to enrollment, chronic kidney disease withestimated glomerular filtration rate (eGFR) < 30 or on dialysis prior to AP, anddecompensated cirrhosis (based on imaging or biopsy), or any other medical conditionthat 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 duringfollow-up will remain in the study, but may have modified study assessments forsafety as detailed in the Manual of Procedures

  • Incarceration

  • Any other condition or factor that would compromise the participant's safety or thescientific integrity of the study

Study Design

Total Participants: 800
Treatment Group(s): 1
Primary Treatment: Dexcom Continuous Glucose Monitor (CGM)
Phase:
Study Start date:
October 16, 2024
Estimated Completion Date:
March 31, 2027

Study 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).

Connect with a study center

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • University of Southern California

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Stanford University

    Stanford, California 94305
    United States

    Active - Recruiting

  • University of Florida

    Gainesville, Florida 32610-0214
    United States

    Active - Recruiting

  • AdventHealth

    Orlando, Florida 32804
    United States

    Site Not Available

  • AdventHealth

    Orlando, FL, Florida 32804
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • University of Illinois at Chicago

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Johns Hopkins University

    Baltimore, Maryland 21205
    United States

    Active - Recruiting

  • University of Minnesota

    Minneapolis, Minnesota 55454
    United States

    Active - Recruiting

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Benaroya Research Institute

    Seattle, Washington 98101
    United States

    Active - Recruiting

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