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New patch could replace fingersticks for 5 days of glucose monitoring

NCT ID NCT06229743

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a small, wearable sensor that sits just under the skin and measures blood sugar continuously for up to 5 days in adults with diabetes. 247 participants wore the sensor along with a standard monitor and took fingerstick tests to compare accuracy. The goal was to see if the sensor works well enough to help people manage their diabetes without needing constant finger pricks.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

247 people

The number who actually took part.

Started

Feb 2024

Finished

Jun 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.

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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. ≥ 22 years old. 2. Willing and able to provide written signed and dated informed consent. 3. Access to phone or computer with internet to complete subject log. 4. Diagnosis of type 1 diabetes (T1D)/ LADA or type 2 diabetes (T2D) and on intensive insulin therapy (IIT) with known dosing parameters for at least three (3) months prior to the Screening Visit with an A1c of 5.5%-10% or diagnosis of type 2 diabetes (T2D) and on non-intensive insulin therapy (NIIT) or T2D not using insulin with an A1c of 7.5% to 11%. 5. Weigh at least 110 lbs (50 kilograms). 6. Be otherwise in good health, as determined by a medical care professional. 7. Willing to refrain from Acetaminophen use for the duration of study enrollment. 8. If using an automated insulin delivery (AID) system, willing to disable automated features and go into open loop mode during the duration of in-clinic days. Device and Glucose Assessments - Willing to: 9. Wear one (1) commercial CGM system on the abdomen per approved labeling and have up to 1 replacement. 10. Wear up to two (2) Biolinq Biowearables simultaneously following the application procedures on the volar forearm for up to 7 days. 11. Participate in two (2) In-Clinic sessions lasting up to 11.5 hours of blood draws (anticipated up to 13 hours on site per visit) each. 12. Perform up to five (5) fingersticks a day with the SMBG device provided during non-in-clinic days. 13. Avoid immersing study devices into water (e.g., no hot tub, SCUBA diving). 14. Wear an activity tracker or record activity levels on a daily log. Exclusion Criteria: 1. Current participation in another investigational study protocol. (If a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study.) Note: Subjects will not be excluded if enrolled in another observational trial, wherein the subject is in the follow-up phase and no tests/procedures impacting the subject's health are required. Subjects will be excluded if they have been previously enrolled in this study. 2. Work for, are family members with, or live with someone that works for the sponsor or competitor diabetes-related company (includes social media influencers or bloggers). 3. In the investigator's opinion, any reason that may lead to subject non-compliance with study requirements or confound study data. 4. Currently taking Hydroxyurea. 5. Known allergy to medical grade adhesives, acrylic, latex, or isopropyl alcohol. 6. Have dermatological conditions that preclude wearing Biolinq Biowearables (e.g., extensive psoriasis, recent burns, severe sunburn, extensive eczema, extensive scarring, dermatitis herpetiformis, skin lesions, erythema, infection, or other conditions at the discretion of the investigator). 7. For subjects of child-bearing potential, pregnant or not practicing an acceptable form of birth control during the study. 8. Hematocrit measurement via point-of-care (POC) or laboratory testing that is less than the applicable below-mentioned value: 1. Male: 36.0% 2. Female: 33.0% 9. Have donated blood, had significant blood loss, or participated in a study with significant blood sampling (340 cc or more) within 56 days prior to study enrollment or plan to participate in such activities during study wear. 10. Required or scheduled to have diathermy, X-ray, MRI, or CT during study wear. 11. In the investigator's opinion, the subject has a history of concomitant medical condition that could interfere with the study participation or present a risk to the safety and welfare of the subject or study staff. Such historical conditions include but are not limited to: 1. Syncope in past 6 months 2. Severe hypoglycemia (loss of consciousness, seizure, or emergency medical technician assistance within the past 6 months) 3. Diabetic ketoacidosis (DKA) requiring hospital admission in the past 6 months 4. Coagulopathy 5. Chronic infectious disease (e.g., HIV/AIDS, Hepatitis B or C) 6. End stage renal disease and currently managed by dialysis or anticipating initiating dialysis during the study wear period 7. History of congestive heart failure

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Advanced Metabolic Care + Research Institute

    Escondido, California, 92025, United States

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318, United States

  • Diabetes and Glandular Disease Clinic

    San Antonio, Texas, 78229, United States

  • Diablo Clinical Research

    Walnut Creek, California, 94598, United States

  • Rainier Clinical Research

    Renton, Washington, 90857, United States

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho, 83404, United States

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Other studies related to the condition(s) this trial covers.