1500 Participants NeededMy employer runs this trial

Extended Wear Sensors for Diabetes

Recruiting at 16 trial locations
RM
Overseen ByRobin Mottackel
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Medtronic MiniMed, Inc.
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 tests new, long-lasting sensors designed to monitor blood sugar levels in individuals with Type 1 or Type 2 diabetes. The goal is to collect data from these sensors to understand their performance in daily life. The trial suits those diagnosed with diabetes for at least six months and willing to use these sensors regularly. As an unphased trial, participants contribute to innovative research that may improve diabetes management.

What prior data suggests that these extended wear sensors are safe for diabetes patients?

Research has shown that new long-lasting sensors for diabetes are safe and accurate. One study found these sensors provided reliable blood sugar readings for up to 180 days. Users reported comfort, and no major safety issues emerged. Another study demonstrated that a similar sensor, the G7, was also safe and effective, delivering accurate readings for over 10 days. These findings suggest that the sensors being tested are likely safe for use with minimal risk of side effects.12345

Why are researchers excited about this trial?

Next Generation Extended Wear Sensors are unique because they offer a longer wear time compared to current continuous glucose monitors (CGMs). Most CGMs need to be replaced every 7 to 14 days, but these new sensors aim for an extended duration, potentially making diabetes management more convenient and less intrusive. Researchers are excited because longer wear times could mean fewer disruptions for users and more consistent glucose monitoring, which can lead to better management of diabetes and improved quality of life.

What evidence suggests that these extended wear sensors are effective for diabetes?

Research has shown that continuous glucose monitoring (CGM) sensors can significantly aid in diabetes management. These devices reduce both the frequency and duration of low blood sugar episodes and improve overall blood sugar control. For individuals with type 2 diabetes, CGM use increased the time their blood sugar remained within the target range by 10.3%. A review of studies involving people with type 1 diabetes showed improvements in key blood sugar measures, such as A1c, which indicates average blood sugar levels over several months. These sensors provide real-time feedback, helping users make better daily decisions without needing to prick their fingers. In this trial, all participants will use the Next Generation Extended Wear Sensors to evaluate their effectiveness in managing diabetes.678910

Are You a Good Fit for This Trial?

This trial is for people aged 2 to 80 years old who have either type 1 or type 2 diabetes. Participants should be able to use a continuous glucose sensor and follow study instructions.

Inclusion Criteria

If participating in BGA FST, has adequate venous access as assessed by investigator or appropriate staff
I am willing to check my blood sugar with a fingerstick when needed.
I have been using insulin for at least 3 months.
See 8 more

Exclusion Criteria

Participating in another pharmaceutical or device trial within 2 weeks of enrollment or anticipates participation during study (observational studies acceptable)
I am currently taking or plan to take hydroxyurea.
Is a sponsor employee or immediate family member (excluding adult children and/or adult siblings)
See 21 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants wear the Next Generation Extended Wear Sensors and data is collected

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Next Generation Extended Wear Sensors

Trial Overview

The study is testing new extended wear glucose sensors that can be worn longer than current models, collecting data on how well they work in people with diabetes.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Next Generation Extended Wear SensorsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medtronic MiniMed, Inc.

Lead Sponsor

Citations

Continuous Glucose Monitoring Sensors for Diabetes ... - PMC

CGM devices have been proved to improve safety and effectiveness of diabetes therapy, reduce hypoglycemia incidence and duration, and decrease glycemic ...

Wearable Continuous Glucose Monitoring Sensors

With a 9% MARD, it is the first and only CGM system that can be used to make daily diabetes treatment decisions without finger pricking [57,58].

6 Best Continuous Glucose Monitors for 2026

Dexcom G7 (Best overall for most users) Wear time: 15.5 days Accuracy: MARD 8.2% (adults), 8.1% (children), and 7.7% for ages 2 to 6. Eversense 365 reduces the ...

Clinical Targets for Continuous Glucose Monitoring Data ...

individuals with type 2 diabetes increased their TIR by 10.3% (from 55.6% to 61.3%) after 24 weeks of CGM use with slight reductions in TBR. ...

Continuous Glucose Monitoring, Mobile Technology ... - NCBI

In a 2023 meta-analysis of 22 RCTs that included participants with T1D, there was an overall improvement in A1c, TIR and TBR (49).

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34515521/

The PROMISE Study

These data show the next-generation Eversense CGM system had sustained accuracy and safety up to 180 days, with an improved calibration scheme ...

Evaluation of MiniMed Next Generation Extended Wear ...

Next Generation Extended Wear Sensors. This study will collect sensor data in subjects with T1D or T2D, 2-80 years of age. subjects will wear ...

The Safety and Efficacy of Next-Generation G7 CGM Over G6

The seventh-generation (G7) continuous glucose monitor provides accurate and safe glucose readings during 10.5 days of use.

Beyond glucose monitoring: Multi-analyte biosensing and ...

Next-generation CGMs can be engineered as multianalyte sensors that can simultaneously also detect other diabetes associated biomarkers like ketones, lactate, ...

8 Next-Gen CGMs In Development You Need To Know About

The Biolinq Shine sensor is designed for people with type 2 diabetes who are not on insulin, and it is the first CGM to ditch the traditional insertion needle ...