Continuous Glucose Monitoring for Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to help people with type 2 or steroid-induced diabetes manage their blood sugar levels after hospital discharge. It compares two groups: one using the Libre 3 Plus continuous glucose monitor, which displays real-time blood sugar levels, and another using a hidden monitor (blinded continuous glucose monitoring) that requires fingerstick tests. The researchers aim to determine which method better aids diabetes management. This study may suit individuals who have been hospitalized for diabetes treatment and plan to use insulin at home. Participants will wear a sensor for 28 days and have telehealth check-ins. As an unphased trial, this study offers a unique opportunity to explore innovative diabetes management strategies and contribute to valuable research.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current medications, as the focus is on monitoring glucose levels with different devices.
What prior data suggests that the Libre 3 Plus continuous glucose monitoring system is safe for diabetes management?
Research has shown that the Libre 3 Plus continuous glucose monitoring (CGM) system presents some safety concerns. Reports have indicated incorrect glucose readings, and some sensors required replacement. Abbott, the device manufacturer, issued a recall due to these problems. They reported 860 serious injuries and seven deaths related to these issues. Despite these concerns, most users generally consider the Libre sensors safe and effective.
In summary, while the Libre 3 Plus CGM system is widely used and typically functions well, important safety alerts have been issued. Potential trial participants should be aware of these issues when considering joining.12345Why are researchers excited about this trial?
Researchers are excited about the trial of the Libre 3 Plus continuous glucose monitoring (CGM) system because it offers a new approach to managing diabetes. Unlike traditional methods that rely on frequent fingerstick blood tests, this system provides real-time, continuous glucose readings without the need for manual checks. The unmasked monitoring allows users to see their glucose levels in real-time, potentially leading to better management of their condition and improved quality of life. Additionally, the trial compares this system with a blinded CGM combined with fingerstick monitoring, which could highlight the advantages of continuous, visible data in diabetes care.
What evidence suggests that this trial's treatments could be effective for diabetes?
Research has shown that the Libre 3 Plus continuous glucose monitoring (CGM) system, one of the treatments tested in this trial, can significantly aid in diabetes management. Studies indicate that using the Libre CGM system can lower A1C levels, a crucial measure of blood sugar control. Specifically, evidence shows a 0.9% reduction in A1C within 3 to 6 months for insulin users. The system provides real-time glucose readings, enabling users to make better decisions about managing their diabetes. Additionally, the Libre 3 CGM demonstrates high accuracy, with about 97-98% of its results closely matching lab standards, even when blood sugar is low. Another arm of this trial involves using Blinded Continuous Glucose Monitoring alongside fingerstick monitoring as an active comparator.678910
Who Is on the Research Team?
Grenye O'Malley, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai
Are You a Good Fit for This Trial?
This trial is for adults (18+) who were hospitalized and treated for type 2 or steroid-induced diabetes, and will need to use insulin after leaving the hospital.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use either the Libre 3 Plus CGM system or blinded CGM and fingerstick monitoring for 28 days post-discharge
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Blinded Continuous Glucose Monitoring
- Libre 3 Plus continuous glucose monitoring (CGM) system
Trial Overview
The study compares two ways of monitoring blood sugar after hospital discharge: one group uses the Libre 3 Plus continuous glucose monitor they can see, while the other uses a blinded CGM plus fingerstick checks. Both groups wear sensors for 28 days and have telehealth visits.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
use of unmasked continuous glucose monitoring
Self-monitoring blood glucose (SMBG)+masked CGM
Find a Clinic Near You
Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor
Citations
Accuracy of a 15-day Factory-Calibrated Continuous Glucose ...
The sensor performed well in the hypoglycemic range, with 97.1% and 98.0% of results within ±15 mg/dL of the YSI comparator for the adult and ...
Dexcom G7 vs. FreeStyle Libre 3 and Libre 3 Plus CGM
1. Accuracy and Overall Effectiveness ... Dexcom G7 has the best accuracy of any CGM available for pediatric users, and Dexcom G7 15 Day is the ...
3.
freestyle.abbott
freestyle.abbott/content/dam/adc/freestyle/eu/attd-2024/documents/superior-accuracy-performance.pdfsuperior-accuracy-performance.pdf
Outcome measures: differences in mean absolute relative difference, differences in overall percentage ±20 mg/dL/±20. Results from 55 subjects. (42 minimum ...
Adult & Pediatric Outcomes - FreeStyle Libre CGM Systems
0.9% A1C reduction within 3 to 6 months among patients treated with basal bolus insulin* · 1.5% A1C reduction at 6 months in patients with suboptimal glycemic ...
Impact of real-time glucose monitoring using FreeStyle Libre 3 ...
Randomized comparison of self-monitored blood glucose (BGM) versus continuous glucose monitoring (CGM) data to optimize glucose control in type 2 diabetes.
Safety Information | The FreeStyle Libre System
Read safety information regarding your FreeStyle Libre 14 day system, including MRI contraindications, insulin contraindications, and sensor removal ...
7.
accessdata.fda.gov
accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=23145716&pc=QBGABBOTT DIABETES CARE INC FREESTYLE LIBRE 3 PLUS
Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.Stability data for libre ...
Meet the FreeStyle Libre 3 Plus sensor
The world's smallest*1 15-day, real-time CGM sensor for all ages (2+)2, with glucose readings sent automatically every minute to your smartphone†, no scanning ...
9.
freestyleserver.com
freestyleserver.com/Payloads/IFU/2024/q3/DOC50021_Rev_A/English/Assets/mi_important_safety_information.htmlFS-Libre-US: Important Information
Important Safety Information. You can use the FreeStyle Libre 3 System with either the FreeStyle Libre 3 Sensor or the FreeStyle Libre 3 Plus Sensor.
10.
aha.org
aha.org/news/headline/2026-02-04-fda-issues-most-serious-recall-certain-glucose-monitor-sensorsFDA issues most serious recall for certain glucose monitor ...
Abbott has reported 860 serious injuries and seven deaths associated with the issue since Jan. 7. Medical Device Safety. Related News Articles.
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