Continuous Glucose Monitoring for Diabetes

Recruiting at 29 trial locations

Overseen By Brynn Marks, M.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Diabetes

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 0

1500 Participants Needed

Trial Summary

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.

Eligibility Criteria

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.

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

Treatment Details

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.

Participant Groups

Group I: Subjects with diabetes wearing DS5 Experimental Treatment 1 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

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