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.
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
800
Dexcom Continuous Glucose Monitor which measures and records a participant's serum glucose level
University of Southern California
Los Angeles, California, United States
RECRUITINGCedars-Sinai Medical Center
Los Angeles, California, United States
RECRUITINGStanford University
Stanford, California, United States
RECRUITINGUniversity of Florida
Gainesville, Florida, United States
RECRUITINGAdventHealth
Orlando, Florida, United States
RECRUITINGNorthwestern University
Chicago, Illinois, United States
RECRUITINGUniversity of Illinois at Chicago
Chicago, Illinois, United States
RECRUITINGIndiana University
Indianapolis, Indiana, United States
RECRUITINGJohns Hopkins University
Baltimore, Maryland, United States
RECRUITINGUniversity of Minnesota
Minneapolis, Minnesota, United States
RECRUITING...and 3 more locations
pre-diabetes mellitus following an episode of acute pancreatitis
time to onset of pre-diabetes mellitus during the 36-month longitudinal follow-up period
Time frame: 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
Time frame: any time during the 36-month longitudinal follow-up period
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
Time frame: any time during the 36-month longitudinal follow-up period
insulin secretion
insulin secretion during the oral glucose tolerance test (OGTT)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: during the frequently sampled intravenous glucose tolerance test (FSIGTT) administered at 3 and 12 months
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