Continuous Glucose Monitoring for Pancreatitis
(DREAM-ON Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how continuous glucose monitoring (CGM) can predict diabetes risk and manage insulin needs after acute pancreatitis, a sudden inflammation of the pancreas. Researchers aim to determine if CGM can provide insights into different diabetes types linked to pancreatitis. The goal is to improve guidelines for treating acute pancreatitis and potentially expand CGM use for those with pancreatogenic diabetes, a type of diabetes related to pancreatic issues. Individuals who experienced acute pancreatitis in the last 90 days and can participate in all study activities might be suitable for this trial. As a Phase 2 trial, this research focuses on measuring CGM's effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking diabetes management strategies.
Do I need to stop my current medications to join the trial?
The trial does not clearly specify if you need to stop your current medications, but it mentions that certain medications are not allowed within 30 days before joining. It's best to check the study's Manual of Procedures for a list of these medications.
What prior data suggests that continuous glucose monitoring is safe for predicting diabetes risk?
Previous studies have shown that continuous glucose monitoring (CGM) is generally safe. Users of CGM devices, such as the Dexcom or FreeStyle Libre, find them easy to use. Some precautions are necessary; for instance, sensors should not be worn during MRI scans, and readings may occasionally need verification with a regular blood glucose meter. However, no serious safety issues have been consistently reported. Overall, evidence suggests that CGM devices are safe for tracking glucose levels in people with diabetes.12345
Why are researchers excited about this trial?
Researchers are excited about using Continuous Glucose Monitoring (CGM) for diabetes related to acute pancreatitis because it offers a real-time, detailed picture of glucose levels, unlike traditional methods that rely on periodic blood tests. This continuous data stream helps identify patterns and fluctuations that might be missed with standard glucose testing, allowing for more precise and timely adjustments in diabetes management. The ability to monitor glucose levels continuously can lead to better metabolic outcomes by reducing the risk of complications and improving overall glucose control.
What evidence suggests that continuous glucose monitoring is effective for predicting diabetes risk after acute pancreatitis?
Research has shown that continuous glucose monitoring (CGM), which participants in this trial will receive, can greatly aid in diabetes management. Studies have found that CGM lowers HbA1c levels, a measure of average blood sugar over time, in both Type 1 and Type 2 diabetes. It also reduces episodes of very low blood sugar. CGM enhances understanding of diabetes and provides better control over blood sugar levels. These benefits suggest that CGM could be beneficial for individuals with diabetes caused by acute pancreatitis.678910
Who Is on the Research Team?
Vernon M Chinchilli, PhD
Principal Investigator
Penn State College of Medicine
Richard E Pratley, MD
Principal Investigator
AdventHealth
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Initial assessment and baseline measurements using CGM and other tests
Longitudinal Follow-up
Participants undergo continuous glucose monitoring and other assessments at scheduled visits
Follow-up
Participants are monitored for safety and effectiveness after the main study period
What Are the Treatments Tested in This Trial?
Interventions
- Dexcom Continuous Glucose Monitor (CGM)
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Continuous Glucose Monitoring (CGM)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Milton S. Hershey Medical Center
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Benaroya Research Institute
Collaborator
Cedars-Sinai Medical Center
Collaborator
University of Southern California
Collaborator
Indiana University
Collaborator
Johns Hopkins University
Collaborator
Ohio State University
Collaborator
Stanford University
Collaborator
University of Florida
Collaborator
Citations
The Effectiveness of Continuous Glucose Monitoring ...
CGM demonstrated improved outcomes in T1DM with lower HbA1c and reduced severe hypoglycemia, while in T2DM, CGM significantly lowered HbA1c ...
Using continuous glucose monitoring to measure and ...
EFFICACY AND UTILITY OF CGM ... Other studies have demonstrated that CGM use significantly enhances users' understanding of their diabetes and ...
Advances in Continuous Glucose Monitoring: Clinical ...
Continuous glucose monitoring systems have revolutionized diabetes management, significantly improving glycemic control in both Type 1 and Type 2 diabetes.
4.
diabetesjournals.org
diabetesjournals.org/clinical/article/43/4/554/162999/Effectiveness-of-Continuous-Glucose-Monitoring-inEffectiveness of Continuous Glucose Monitoring in a ...
On average, A1C decreased by 2.9 ± 2.2%, with 75.8% of participants reaching an A1C <9% and 18.6% reaching an A1C <7%. These outcomes were ...
CGM l Effectiveness of CGMs l danatech
Multiple research studies confirm the effectiveness of continuous glucose monitoring · Decreased HbA1C · Decreased glycemic variability · Increased time in range ...
FDA - Summary of Safety and Effectiveness Data (SSED)
IV. WARNINGS AND PRECAUTIONS. The warnings and precautions can be found in the Dexcom G4 PLATINUM Continuous. Glucose Monitoring System labeling. V ...
Safety Information | The FreeStyle Libre System
Read safety information regarding your FreeStyle Libre 14 day system, including MRI contraindications, insulin contraindications, and sensor removal ...
Guidance for the Use of Continuous Glucose Monitoring in ...
Studies have demonstrated the safety of direct dosing from CGM data without confirmatory fingersticks. ² However, a blood glucose meter should be available for ...
Safety and Functional Integrity of Continuous Glucose ...
The CGM Pro and CGM 3 sensors store 14 days of data, whereas the CGM 1 and CGM 2 sensors store eight hours of data, after which the continuous data logging ...
CGM Safety Information
Read essential safety information on all of Dexcom's continuous glucose monitoring systems and software.
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