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Continuous Glucose Monitoring System

Continuous Glucose Monitoring for Diabetes

N/A

Waitlist Available

Research Sponsored by Bionime Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must have a diagnosis of type 1 or type 2 diabetes mellitus

Subjects must be 18 years and older

Must not have

Diagnosed with hemophilia or any other bleeding disorders

Presence of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on skin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 days

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see how well and how safe a new continuous glucose monitoring system works in adults with diabetes.

Who is the study for?

Adults with either Type 1 or Type 2 diabetes who can attend all study visits, wear two sensors on their arms, and understand English. They must be willing to provide written consent and able to follow device instructions.

What is being tested?

The trial is testing the RIGHTEST Continuous Glucose Monitoring System's effectiveness and safety in managing blood glucose levels for adults with diabetes.

What are the potential side effects?

While specific side effects are not listed, typical CGM system-related side effects may include skin irritation at the sensor site, potential allergic reactions to adhesive, or inaccurate readings leading to mismanagement of glucose levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with type 1 or type 2 diabetes.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with hemophilia or another bleeding disorder.

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I cannot wear sensors due to skin conditions.

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I am of childbearing age and not pregnant or planning to become pregnant during the study.

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I have kidney disease.

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I am on dialysis or expect to start it during the study.

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I have stable heart or blood vessel disease with current treatment.

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I have not had severe low blood sugar, DKA, seizures, or major diabetes complications in the last 6 months.

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I have type 2 diabetes, use insulin, and am on SGLT2 inhibitors.

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I weigh less than 110 pounds.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

RIGHTEST Continuous Glucose Monitoring System Performance

Secondary study objectives

To investigate the RIGHTEST Glucose Monitoring System other system performance and safety

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CGM SystemExperimental Treatment1 Intervention

Blood draw and glucose challenge will be performed to evaluate the performance of the CGM system compared to reference measurements during the in in-clinic visits.

0 / 11Eligibility criteria met