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Continuous Glucose Monitoring for Diabetes

Recruiting at 29 trial locations
LL
MH
BR
LE
DK
PB
BM
CD
Overseen ByCarla Demeterco-Berggren, M.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 5 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to find out how well a new continuous glucose monitor works for people with diabetes. This study will test the performance of the study sensor(s) for 7-14 days of wear in patients who are 11-80 years old with type 1 or type 2 diabetes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you have type 1 diabetes and are using pramlintide, DPP-4 inhibitors, GLP-1 receptor agonists, metformin, or SGLT2 inhibitors, you cannot participate. Also, if you are using hydroxyurea, you cannot join the study.

Is continuous glucose monitoring safe for humans?

Continuous glucose monitoring systems, including flash glucose monitoring, have been evaluated for safety in various studies. One study specifically looked at the safety and patient tolerance of a new system in children with type 1 diabetes, allowing them to participate in normal activities, suggesting it is generally safe for use.12345

How is continuous glucose monitoring different from other diabetes treatments?

Continuous glucose monitoring (CGM) is unique because it provides real-time data on glucose levels by measuring the glucose in the fluid between cells, allowing for immediate adjustments in diabetes management. Unlike traditional methods that require finger-prick blood tests, CGM systems like the flash glucose monitoring (FGM) allow users to scan a sensor for on-demand access to glucose data, helping to prevent high and low blood sugar events.15678

What data supports the effectiveness of the treatment Continuous Glucose Monitoring for Diabetes?

Research shows that using flash continuous glucose monitoring (CGM) helps people with diabetes keep their blood sugar levels within the target range more often and reduces the time spent in high or low blood sugar levels. This technology provides immediate information, allowing users to make quick adjustments to their treatment, which has been shown to improve health outcomes in both type 1 and type 2 diabetes.257910

Are You a Good Fit for This Trial?

This trial is for people aged 11-80 with either type 1 or type 2 diabetes. It's designed to test a new continuous glucose monitor over a period of 7-14 days.

Inclusion Criteria

My veins are suitable for drawing blood or giving treatments, as confirmed by a healthcare professional.
Subject or parent(s)/guardian(s) is/are literate and able to read the language offered in the study materials
I am between 11 and 80 years old.
See 5 more

Exclusion Criteria

Has had a hypoglycemic seizure within the past 6 months prior to screening visit
Has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to enrollment
Has a history of allergy to dexamethasone or has been told by health care provider they may not take any products containing dexamethasone
See 23 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants wear the continuous glucose monitor for 7-14 days to test its performance

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Continuous Glucose Monitoring
Trial Overview Participants will use the next generation sensors (NGS) and algorithm that are part of a new continuous glucose monitoring system, which helps track blood sugar levels in real-time.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Subjects with diabetes wearing DS5Experimental Treatment1 Intervention
Subjects wearing DS5 over 7-14 days and participating in FSTs

Continuous Glucose Monitoring is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Continuous Glucose Monitoring for:
  • Type 1 diabetes
  • Type 2 diabetes
🇪🇺
Approved in European Union as Continuous Glucose Monitoring for:
  • Type 1 diabetes
  • Type 2 diabetes
  • Gestational diabetes
🇨🇦
Approved in Canada as Continuous Glucose Monitoring for:
  • Type 1 diabetes
  • Type 2 diabetes
🇯🇵
Approved in Japan as Continuous Glucose Monitoring for:
  • Type 1 diabetes
  • Type 2 diabetes

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medtronic Diabetes

Lead Sponsor

Trials
73
Recruited
11,800+

Geoff Martha

Medtronic Diabetes

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Kweli Thompson

Medtronic Diabetes

Chief Medical Officer since 2022

MD from Harvard Medical School

Published Research Related to This Trial

The user-calibrated real-time continuous glucose monitoring (rt-CGM) system demonstrated superior accuracy compared to the factory-calibrated flash glucose monitoring (FGM) system, with a mean absolute relative difference of 9.7% for rt-CGM versus 17.5% for FGM, indicating better performance in tracking blood glucose levels.
Despite the higher accuracy of rt-CGM, both systems were generally perceived as easy to use and helpful for managing diabetes, although cost concerns limited the willingness of participants to adopt either device for continuous monitoring.
A head-to-head comparison between Guardian Connect and FreeStyle Libre systems and an evaluation of user acceptability of sensors in patients with type 1 diabetes.Yeoh, E., Png, D., Khoo, J., et al.[2022]
Flash continuous glucose monitoring (CGM) offers an affordable and user-friendly option for patients, allowing them to scan a sensor for real-time glucose data, which can help in adjusting therapy and understanding glucose patterns.
Increased scanning frequency with flash CGM is linked to better glycemic control, showing more time spent in the target glucose range and less time in hyperglycemia and hypoglycemia, highlighting its potential benefits for diabetes management.
Flash Continuous Glucose Monitoring: Implications for Use of Continuous Data in Daily Diabetes Management.Hirsch, IB., Nardacci, E., Verderese, CA.[2020]
New 'flash' continuous glucose monitoring (CGM) technology is emerging as a more affordable and user-friendly option for diabetes management, potentially increasing its accessibility for patients.
This novel CGM approach aims to provide continuous data that can be used more routinely in primary care settings, enhancing daily diabetes management for a larger number of patients.
Using Flash Continuous Glucose Monitoring in Primary Practice.Hirsch, IB., Wright, EE.[2021]

Citations

A head-to-head comparison between Guardian Connect and FreeStyle Libre systems and an evaluation of user acceptability of sensors in patients with type 1 diabetes. [2022]
Flash Continuous Glucose Monitoring: Implications for Use of Continuous Data in Daily Diabetes Management. [2020]
Using Flash Continuous Glucose Monitoring in Primary Practice. [2021]
Practical guidance for treatment of patients with diabetes using flash glucose monitoring: a pilot study. [2022]
Flash Continuous Glucose Monitoring: A Summary Review of Recent Real-World Evidence. [2022]
Clinical Approach to Flash Glucose Monitoring: An Expert Recommendation. [2021]
Extended use of a new continuous glucose monitoring system with wireless data transmission in children with type 1 diabetes mellitus. [2009]
Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. [2023]
Comparison of glucose monitoring between Freestyle Libre Pro and iPro2 in patients with diabetes mellitus. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Accuracy of a Flash Glucose Monitoring System in Diabetic Dogs. [2022]
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