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Smart insulin pump shows promise for diabetics with kidney failure

NCT ID NCT06330194

Disease control Sponsor: Steno Diabetes Center Copenhagen 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 an automated insulin delivery system (a smart pump) in 15 adults with type 1 or type 2 diabetes who also had advanced kidney disease or were on dialysis. Participants used the system for 8 weeks, then switched to their usual care for another 8 weeks. The goal was to see if the smart pump could better control blood sugar levels and reduce dangerous lows compared to standard treatment.

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

15 people

The number who actually took part.

Started

Apr 2024

Finished

Jul 2025

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 to 75 years

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. Written informed consent obtained before any trial-related procedures are performed 2. Type 1 diabetes of at least 1-year duration or insulin requiring type 2 diabetes (Total insulin dose should be below 200 IE per day) 3. Maintenance HD, PD, or CKD stage 3b-5 (not on dialysis). 4. Subject must be willing and able to comply with trial protocol 5. HbA1c \<91 mmol/mol (10.5%) All participants will require to have internet or mobile phone access enabling upload of the AID system data to cloud based software. Exclusion Criteria: 1. History of ketoacidosis within the past 6 months 2. Moderate to severe cognitive impairment 3. Major allergy to tape/ adhesives 4. Women who are pregnant or planning pregnancy 5. Life-expectancy to \<6 months 6. Major psychiatric history 7. Treatment with sulphonylureas in pre-dialysis participants (SGLT2 inhibitors, metformin, and GLP1 analogues may be used within regulatory guidelines) 8. Treatment with non-insulin glucose lowering therapies may not be used on dialysis participants (with the exception of GLP1 agonists used in preparation for transplantation) 9. Systemic steroid treatment within 4 weeks (stable doses of steroids \>8 weeks allowed) 10. Visual impairment

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome type 1 diabetes mellitus type 1 diabetes mellitus 1 type 2 diabetes mellitus wild type ABeta2M amyloidosis

As listed by the trial registrant

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

Chronic kidney disease Diabetes mellitus type 2 Diabetes mellitus, type 1 Dialysis Hemodialysis Peritoneal dialysis

Contacts and locations

Locations

  • Tobias Bomholt

    Copenhagen, 2100, Denmark

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