Enhanced CGM for Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to make continuous glucose monitoring (CGM), a tool that tracks blood sugar levels in real-time, more accessible in primary care settings for people with diabetes. The researchers seek to determine if their program, SPARK-CGM, can enable more primary care providers to prescribe CGM devices to their patients. They anticipate that this will lead to better blood sugar control and an improved quality of life for people with diabetes. Suitable participants include adults with diabetes who receive primary care at Montefiore Medical Center and are on insulin therapy. As an unphased trial, this study offers a unique opportunity to contribute to the wider availability of CGM, potentially enhancing diabetes management for many.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It focuses on using continuous glucose monitoring for diabetes management.
What prior data suggests that the SPARK-CGM program is safe for use in primary care settings?
Past research has raised safety concerns about some continuous glucose monitors (CGMs). Abbott identified that certain CGM sensors were linked to seven deaths and over 700 serious injuries due to incorrect blood sugar readings. These issues arose mainly because the sensors displayed falsely low blood sugar levels, posing a danger. Consequently, about 3 million sensors required replacement.
These problems were specific to certain models and brands. Generally, CGMs are safe and effective for monitoring blood sugar levels. To reduce risks, ensure proper device function by following healthcare provider advice and device instructions.12345Why are researchers excited about this trial?
Researchers are excited about the Enhanced CGM for Diabetes trial because it focuses on improving the use and understanding of continuous glucose monitors (CGM) in clinical settings. Unlike standard care, which often involves periodic glucose checks and insulin adjustments, this trial aims to streamline CGM integration into clinics. Key features include developing clinic workflows for CGM prescribing, educating providers on interpreting CGM data, and training staff to support CGM use. This approach could lead to more personalized and effective diabetes management, improving patient outcomes and clinic efficiency.
What evidence suggests that SPARK-CGM is effective for increasing CGM use in primary care?
Research has shown that continuous glucose monitoring (CGM) can significantly help people with diabetes manage their blood sugar levels. Studies indicate that CGM lowers average blood sugar levels (HbA1c), reduces episodes of severe hypoglycemia, and increases the time spent in the target blood sugar range. For example, one study found that real-time CGM increased time in the target range by about 5.63% and reduced low blood sugar episodes by 1.28%. These findings suggest that CGM can enhance blood sugar control and improve the overall quality of life for individuals with type 1 and type 2 diabetes. In this trial, clinics will implement the SPARK-CGM system during the intervention phase to assess its impact on diabetes management.678910
Who Is on the Research Team?
Jovan Milosavljevic, MD
Principal Investigator
Montefiore Medical Center
Are You a Good Fit for This Trial?
This trial is for adults (18+) with any type of diabetes who get their primary care at Montefiore clinics and are treated with insulin. It also includes clinic staff and clinicians involved in diabetes care or CGM use at these sites.Inclusion Criteria
Timeline for a Trial Participant
Pre-implementation
Patients receive usual care under the direction of their primary care provider and practice
Implementation
Clinics transition from usual care to the SPARK-CGM intervention, including development of workflows, provider education, and staff training
Follow-up
Participants are monitored for CGM utilization, hospitalizations, ED visits, and glucose management indicators
What Are the Treatments Tested in This Trial?
Interventions
- SPARK-CGM
Trial Overview
The study compares usual diabetes care to an enhanced program (SPARK-CGM) that helps primary care teams prescribe and support continuous glucose monitors (CGMs) for people with diabetes, aiming to increase access and use of this technology.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Active Control
Clinics will sequentially transition from the usual care (control) condition to the intervention phase at three-month intervals until all clusters receive the intervention. The active implementation phase at each cluster will span six months, providing sufficient time to equip clinics to use CGM. The intervention includes development of clinic workflows for CGM prescribing and onboarding, provider education on CGM use and interpretation, training of clinic staff to support CGM initiation, and regular performance feedback on CGM prescribing rates.
Patients in pre-implementation practices will receive the usual care under the direction of their primary care provider and practice.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Montefiore Medical Center
Lead Sponsor
American Diabetes Association
Collaborator
Citations
SPARK: an mHealth intervention for self-management and ...
The primary outcome is glycaemic control (time in range, TIR, % of time according to recent international clinical target levels13 with local guidelines taken ...
CGM Optimizing Diabetes Outcomes
The optimization of technology using continuous glucose monitoring (CGM) to improve diabetic outcomes even more.
The Effectiveness of Continuous Glucose Monitoring Devices ...
CGM demonstrated improved outcomes in T1DM with lower HbA1c and reduced severe hypoglycemia, while in T2DM, CGM significantly lowered HbA1c ...
Effectiveness of continuous glucose monitoring systems on ...
Real-time CGM showed advantages over intermittently scanned CGM for TIR (+5.63 %, P-value<0.001) and hypoglycemia reduction (−1.28 %, P-value< ...
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 ...
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facebook.com
facebook.com/AARP/posts/the-fda-is-warning-those-with-certain-glucose-monitor-sensors-to-stop-using-them/1306129711561073/The FDA is warning those with certain glucose monitor ...
Abbott reported 736 severe adverse events and seven potential deaths linked to the faulty devices. Users are urged to immediately stop using the ...
CGM Interfering Substances & Procedures
These substances, such as certain medications, vitamins or procedures, have the potential to affect CGM accuracy, leading to inaccurate readings.
Faulty glucose monitors linked to 7 deaths
Abbott reported that faulty CGM sensors have been linked to seven patient deaths and hundreds of serious injuries. Two models were found to ...
Safety and Functional Integrity of Continuous Glucose ... - PMC
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 ...
10.
cardiovascularbusiness.com
cardiovascularbusiness.com/topics/clinical/heart-health/abbott-shares-safety-concerns-millions-cgm-sensors-7-deaths-reportedAbbott shares safety concerns with millions of CGM ...
Approximately 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors need to be replaced due to a risk of incorrect glucose readings ...
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