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Smart insulin pump could ease diabetes in cystic fibrosis patients

NCT ID NCT05562492

Disease control Sponsor: University of Cambridge 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a hybrid closed-loop system (CamAPS FX) can improve blood sugar control in people aged 16 and older with cystic fibrosis-related diabetes. The system combines an insulin pump, continuous glucose monitor, and smartphone app to automatically adjust insulin. Over 26 weeks, researchers will compare this approach to standard insulin therapy with glucose monitoring in 128 participants.

What this could mean

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

Active substance
CamAPS FX hybrid closed-loop system (insulin pump, continuous glucose monitor, and smartphone app)
What this could lead to
If successful, this could offer a more automated and effective way to manage blood sugar in cystic fibrosis-related diabetes, potentially reducing complications and improving quality of life.
What could go wrong
This is a relatively small, early-stage trial (128 participants) and the technology may not work for everyone. There are risks of device malfunction or hypoglycemia, and the system requires 24/7 wear and training.

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 128 people

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

Started

Apr 2023

Expected to finish

Oct 2026

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

16 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: 1. Participant has cystic fibrosis related diabetes requiring insulin therapy for \>3 months. 2. The participant is 16 years of age or older 3. Baseline time in target glucose range \<80% 4. FEV1 \>30% of predicted mean for age, sex, race, and height (equations of the Global Lung Function Initiative \[GLI\]) at the screening visit or within the past 6 months 5. Participant is willing to wear / carry study devices 24/7 (CGM / insulin pump / smartphone) 6. Participant is willing to follow study specific instructions Exclusion Criteria: 1. Any physical or psychological disease or condition likely to interfere with the normal conduct of the study or interpretation of study results as judged by the investigator 2. Commencement of CFTR modulator therapy within previous 1 month 3. Previous solid organ transplant within the last 12 months or active on transplant waiting list 4. Use of closed-loop insulin therapy within the past 30 days 5. Known or suspected allergy to insulin 6. Severe visual impairment 7. Severe hearing impairment 8. Medically documented allergy or unable to tolerate the adhesive of plasters 9. Serious skin diseases at places of the body corresponding with sensor insertion sites 10. Participant is pregnant or breast feeding or planning pregnancy within next 12 months

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Conditions

The condition(s) this trial relates to.

cystic fibrosis-related diabetes

As listed by the trial registrant

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

Cystic fibrosis-related diabetes

Contacts and locations

Locations

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • All Wales Adult CF Centre

    Cardiff, United Kingdom

  • Belfast City Hospital

    Belfast, United Kingdom

  • Glenfield Hospital

    Leicester, United Kingdom

  • Kings College Hospital

    London, United Kingdom

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, United Kingdom

  • Queen Elizabeth University Hospital

    Glasgow, United Kingdom

  • Royal Brompton Hospital

    London, United Kingdom

  • Royal Papworth Hospital

    Cambridge, United Kingdom

  • Royal Stoke University Hospital

    Stoke-on-Trent, United Kingdom

  • Southampton General Hospital

    Southampton, United Kingdom

  • St Bartholomew's Hospital

    London, United Kingdom

  • University Hospitals Bristol NHS Foundation Trust

    Bristol, United Kingdom

  • Wythenshawe Hospital, Manchester University NHS Foundation Trust

    Manchester, United Kingdom

More trials for these conditions

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