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Can a tiny implant track glucose, ketones, and lactate in diabetes?

NCT ID NCT07745998

Diagnosis Sponsor: Indigo Diabetes NV 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This trial is testing a new implantable sensor called the HALO System in people with type 1 or type 2 diabetes. The sensor is designed to continuously measure glucose, ketones, and lactate in the fluid just beneath the skin, which could give a more complete picture of metabolic health than glucose alone. The study will check how accurate and stable the sensor readings are over three months, and whether the implantation procedure is safe. If it works, this technology might one day help people with diabetes better manage their condition and avoid dangerous highs and lows.

What this could mean

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

Active substance
The HALO System, an implantable continuous multi-metabolite monitoring sensor that measures glucose, ketones, and lactate in interstitial fluid.
What this could lead to
If successful, this could lead to a more comprehensive, implantable monitoring device for diabetes, potentially reducing complications from glucose swings.
What could go wrong
This is an early feasibility study with only 12 participants, so results may not generalize. Risks include implantation procedure complications and device-related adverse events.

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

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

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

18 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: * Willing to sign an informed consent form * Age ≥ 18 years * Willing to comply to study protocol requirements (study visits with frequent venous blood sampling and deliberate insulin, glucose, ketone and lactate challenges) * Willing to charge the SENSOR on daily basis * Willing not to insert their standard CGM and/or insulin pump in and around the SENSOR implant site (± radius 5 cm)\[TS\| XR1.1\] Diagnosed with type 1 diabetes mellitus according to the World Health Organization criteria, for at least 12 months prior to screening, on CSII therapy Exclusion Criteria: * Known allergy to polydimethylsiloxane (PDMS) * A contraindication to undergo challenging tests (i.e., ischemic heart disease, epilepsy, panhypopituitarism, hypoadrenalism, untreated hypothyroidism) * History of hepatitis C or HIV or other disease transmissible by blood * A condition requiring or likely to require magnetic resonance imaging during the study duration * Female participants who are pregnant, planning on becoming pregnant or nursing * Coagulation disorder, wound healing and bleeding disorder or taking anticoagulant medication (oral anticoagulants; antiplatelets (such as aspirin, ticagrelor are allowed). * Anemia identified by a haemoglobin \<14 g/dL for men or \<12 g/dL for women * The presence of any other active implanted device * The presence of any other CGM sensor/pump located in the lower abdomen (other location is acceptable) * Waist circumference of \>120 cm * Any disorder, which in the investigator's opinion might jeopardise participants' safety or compliance with the protocol.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus diabetic ketoacidosis hyperglycemia hypoglycemia type 1 diabetes mellitus type 1 diabetes mellitus 1 type 2 diabetes mellitus

As listed by the trial registrant

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

Diabetes mellitus Diabetes mellitus type 2 Diabetes mellitus, type 1 Hyperglycaemia (diabetic) Hypoglycemia (diabetic) Ketoacidosis, diabetic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. 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.

More trials for these conditions

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