Smart insulin pump may shield kidneys in diabetes patients

NCT ID NCT06925217

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Recruitment status, easiest to join first

Recruiting now This study
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.
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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 Results may not be published yet.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
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Status unknown
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First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a fully automated insulin delivery system (CamAPS HX) can improve kidney oxygen levels in people with type 2 diabetes and chronic kidney disease. About 76 adults will use either the automated system or standard insulin therapy with a glucose monitor for 26 weeks. The main goal is to see if the automated system helps protect kidney tissue.

What this could mean

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

Active substance
CamAPS HX fully closed-loop insulin delivery system (device)
What this could lead to
If successful, this could show that automated insulin delivery helps protect kidney function in people with type 2 diabetes and kidney disease.
What could go wrong
This is a small, early-stage study (76 people) focused on a kidney imaging marker, not hard outcomes like kidney failure. The device may not improve kidney health or could cause hypoglycemia.

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 76 people

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

Started

Jun 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

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

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: * Informed consent signed by the subject * Age 18 years and older * Type 2 diabetes diagnosed for at least 12 months * Treatment with insulin therapy for at least 6 months * CKD defined either as an eGFR 30-59 ml/min/1.73m² or presence of albuminuria \> 3 mg/mmol (stage A2 or A3 according to KDIGO) with an eGFR \> 30 ml/min/1.73m². CKD must be present for at least 6 months. * HbA1c \< 12% based on a venous blood sample from the screening visit * Receiving treatment with an SGLT2 inhibitor and/or GLP-1 receptor agonist for at least 3 months, have been offered these therapies previously, or contraindication/intolerance to receiving these therapies * Willing to wear study devices and follow study instructions * Capable of giving an informed consent Exclusion Criteria: * Type 1 diabetes * Current use of insulin pump * Current use of any closed-loop system * Alternative cause of CKD according to medical records such as polycystic kidney disease, glomerulonephritis, congenital urogenital tract diseases, etc. * Known or suspected allergy against insulin * Pregnancy, planned pregnancy, or breast feeding * Severe visual impairment * Severe hearing impairment * Two or more episodes of severe hypoglycemia in the last 6 months * Medically documented allergy towards the adhesive (glue) of plasters * Serious skin diseases located at places of the body, which potentially are possible to be used for localisation of the glucose sensor * Any physical/psychological disease or medication(s) likely to interfere with the conduct of the study and interpretation of the study results, as judged by study clinician * Recent (less than three months) history of myocardial infarction, percutaneous coronary intervention, stroke, or hospitalization for heart failure with reduced ejection fraction * History of renal transplantation requiring ongoing immunosuppressive therapy * Known or suspected non-compliance, drug or alcohol abuse * Inability to follow the procedures of the investigation, e.g. due to language problems * Incapacity to give informed consent * Contra-indication to undergo MR-imaging according to a standard checklist such as the presence of a pacemaker or other implanted metallic device or severe claustrophobia. * Subject refuses to be informed of incidental findings related to their health discovered during imaging or other study-related exams * Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation * Previous enrolment into the current investigation * Enrolment of the PI, his/her family members, employees and other dependent persons

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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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • CHUV

    RECRUITING

    Lausanne, Switzerland

  • Centre Hospitalier Universitaire Vaudois

    NOT_YET_RECRUITING

    Lausanne, Canton of Vaud, 1011, Switzerland

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