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New glucose monitor put to the test for accuracy

NCT ID NCT05806554

Diagnosis Sponsor: Sinocare Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed trial tested how accurately the True Vie I3 continuous glucose monitor measures blood sugar levels in 159 adults with type 1 or type 2 diabetes. Participants wore the device while researchers compared its readings to standard lab measurements. The goal was to see if the device meets FDA accuracy standards for integrated continuous glucose monitors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Continuous glucose monitoring device
What this could lead to
If successful, this device could provide reliable, real-time glucose readings to help people with diabetes manage their condition more easily.
What could go wrong
This is a completed device accuracy study, not a treatment trial. Even if accurate, the device does not cure diabetes or replace standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

159 people

The number who actually took part.

Started

Jul 2023

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) using an insulin treatment regimen based on carbohydrate (CHO) counting for meal insulin dose determination and 18-80 years of age will be recruited to participate in the study. Both participants using and not using CGM will be recruited, and participants with a wide range of BMIs and ages will be represented.

Ages

18 to 80 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1\. Patients with T1DM or T2DM diagnosed for at least 6 months. 2. Individual is 18-80 years old, inclusive, at the time of screening. 3. Must be and have been in stable treatment regimen for at least 1 month with a multiple daily insulin dosing regimen (at least two insulin doses with meals daily) or CSII using at least two bolus doses a day with meals, irrespective of delivery device(s). Exclusion Criteria: * 1\. History of skin adhesive tolerance issues in the area of sensor placement. 2. HbA1c \> 9%. 3. Insulin meal dosing based on fixed dose regimens. 4. Absence of established correction factor for high glucose. 5. Hematocrit below 10% under the lower limit of the normal range. 6. Body mass index \< 18.5 kg/m2. 7. Inadequate intravenous access on arms. 8. Participant has had a hypoglycemic seizure within the past 6 months prior to enrollment. 9\. Participant has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to enrollment. 10\. Participant has a history of a seizure disorder. 11. Pregnancy, planned pregnancy within the study period, or unwillingness to use reliable contraception during the study period. 12\. Planned MRI, CT scan or diathermia procedure for the duration of the study.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus type 1 diabetes mellitus type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus

Contacts and locations

Locations

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318, United States

  • Diablo Clinical Research

    Walnut Creek, California, 94598, United States

  • Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

    Ulm, D-89081, Germany

  • PSHI Praxis GmbH

    Mainz, 55128, Germany

  • Rainier Clinical Research Center

    Renton, Washington, 98057, United States

  • Woodland Research Northwest

    Rogers, Arkansas, 72758, United States

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