New wearable could double diabetes monitoring power
NCT ID NCT07139808
First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times
Summary
This study is testing a new wearable device that continuously measures both glucose (sugar) and ketone levels in adults with type 1 diabetes. The device is worn for 15 days and its readings are compared to standard lab tests. The goal is to see if it is accurate and safe enough for everyday use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GK5 CGKM (continuous glucose and ketone monitoring device)
- What this could lead to
- If successful, this could provide a more accurate and convenient way for people with type 1 diabetes to monitor both glucose and ketone levels, potentially improving daily disease management.
- What could go wrong
- This is a very small, early-stage study with only 12 participants, focused on accuracy and safety rather than health outcomes. The device may not prove significantly better than existing monitors, and results may not apply to all patients.
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
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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
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Age ≥ 18 years * Diagonsed with T1DM on Continuous subcutaneous insulin infusion (CSII) * Venous blood sampling access can be established in the forearm * Capable of independently reading instructions and complying with the clinical trial requirements * Willing to sign the Informed Consent Form (ICF) Exclusion Criteria: * Severe hypoglycemia within the past 6 months * A diagnosed history of Diabetic ketoacidosis (DKA) in the past 3 months * Heart failure or hemiplegic sequelae due to prior cerebrovascular disease * Severe skin conditions at the sensor wear site * Extensive systemic skin disorders * Having difficulty with wound healing, bleeding disorders, and/or taking anticoagulant medications * Anemia or abnormal hematocrit * Blood donation within the past 6 months * Pregnancy (defined as positive urine test in women ≤55 years), lactation, or plans for pregnancy within ≤30 days * Current or recent (≤1 month) participation in other clinical trials * Planned MRI/CT scans during sensor wear * Allergy to medical adhesives or alcohol * Conditions impairing comprehension of informed consent or study procedures * Other exclusionary conditions per investigator's discretion
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Henan University of Science and Technology
RECRUITINGLuoyang, Henan, 471003, China
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The First Hospital of Hebei Medical University
RECRUITINGShijiazhuang, Hebei, 050000, China
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Other studies related to the condition(s) this trial covers.
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- Carb showdown: which diet best controls type 1 diabetes?
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- Could a simple sugar help people with type 1 diabetes exercise safely?
- New study asks: is this glucose monitor a Game-Changer for diabetes?