20000 Participants NeededMy employer runs this trial

Enhanced CGM for Diabetes

RA
Overseen ByRosina Antwi
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Montefiore Medical Center
Must be taking: Insulin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

JM

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

I provide patient care or help with CGM at a participating primary care clinic.
I am 18 years old or older.
* Receive primary care at participating sites
See 3 more

Timeline for a Trial Participant

Pre-implementation

Patients receive usual care under the direction of their primary care provider and practice

Varies

Implementation

Clinics transition from usual care to the SPARK-CGM intervention, including development of workflows, provider education, and staff training

6 months
Regular visits for training and feedback

Follow-up

Participants are monitored for CGM utilization, hospitalizations, ED visits, and glucose management indicators

Up to 18 months

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?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Implementation PhaseExperimental Treatment1 Intervention
Group II: Pre-implementation phaseActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials
468
Recruited
599,000+

American Diabetes Association

Collaborator

Trials
148
Recruited
102,000+

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 ...

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 ...

Abbott 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 ...