Can a wearable sensor outsmart diabetic ketoacidosis?
NCT ID NCT07739342
First seen Jul 31, 2026 · Last updated Jul 31, 2026
Summary
This study looks at whether a wearable device that tracks both glucose and ketones can help people with type 1 diabetes avoid diabetic ketoacidosis (DKA), a serious complication. About 1,200 adults and children with type 1 diabetes will use the Abbott Continuous Dual Glucose Ketone Monitoring System instead of standard care. Researchers will track how often DKA occurs while participants manage their diabetes with this device.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Abbott Continuous Dual Glucose Ketone Monitoring System (a wearable device that continuously measures glucose and ketone levels)
- What this could lead to
- If successful, this device could help people with type 1 diabetes avoid dangerous episodes of diabetic ketoacidosis by alerting them early to rising ketone levels.
- What could go wrong
- The trial is observational, so it cannot prove the device directly prevents DKA. Results may vary by age group, and the device's accuracy and user adherence could affect outcomes.
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
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About 1,200 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
Type I Diabetic patients
- Ages
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2 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: 1. Aged at least 2 years old at the time of study enrollment. 2. Diagnosis of type 1 diabetes with at least 12 months of diabetes medical history. 3. In the investigator's opinion, the participant is willing to wear the sensor, follow study specific instructions, and perform all study tasks. 4. Willing and able to provide written signed and dated informed consent (adults) or participant's parent/legal guardian must be willing and able to provide written signed and dated informed consent along with assent form completed by the participant for those mature enough to make their own decisions per investigator assessment (those less than 16 years of age). Exclusion Criteria: 1. In the investigator's opinion, the participant has a known (or suspected) allergy to medical grade adhesives at enrollment that would interfere with participant completing study required activities. 2. In the investigator's opinion, the participant has concomitant medical condition(s) which could interfere with the study or present a risk to the safety or welfare of the participant or study staff. 3. Participant is currently in another clinical study which may affect glucose or ketone management (or does so during the study). 4. Participant is unsuitable for participation due to any other cause as determined by the investigator. 5. Participant has implanted medical devices such as pacemakers or requires dialysis or is critically ill.
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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
7 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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Aotearoa Diabetes Collective
Hamilton, 3204, New Zealand
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Health New Zealand-Southern
Dunedin, Otago, 9016, New Zealand
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New Zealand Clinical Research
Christchurch, Christchurch Central City, 8011, New Zealand
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New Zealand Clinical Research
Wellington, 6011, New Zealand
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Optimal Clinical Trials
Auckland, 1010, New Zealand
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Optimal Clinical Trials (North)
Rosedale, Auckland, 0632, New Zealand
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Te Pae Hauora o Ruahine o Tararua /MidCentral Health New Zealand
Palmerston North, 4414, New Zealand
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