Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401577
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-05-02
Brief Title:
Diabetes RElated to Acute Pancreatitis and Its Mechanisms Metabolic Outcomes Using Novel CGM Metrics
Sponsor:
Milton S Hershey Medical Center
Organization:
Milton S Hershey Medical Center
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DREAM-ON
Brief 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
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 mgdL time above 250 mgdL 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 mgdL time above 250 mgdL 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 ie insulin deficient vs insulin resistant
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 mgdL time above 250 mgdL 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 mgdL time above 250 mgdL 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 ie insulin deficient vs insulin resistant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None