Smart insulin pump could ease diabetes management for kidney patients on dialysis
NCT ID NCT07422532
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether an automated insulin delivery system (the Omnipod 5) can help people with type 2 diabetes who are on dialysis achieve better blood sugar control. Half of the 84 participants will use the automated system, while the other half will continue their usual insulin injections. The goal is to see if the device improves glucose levels and quality of life over 12 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Omnipod 5 automated insulin delivery system
- What this could lead to
- If it works, this could offer a safer, easier way for people with type 2 diabetes on dialysis to manage their blood sugar without constant finger-prick tests.
- What could go wrong
- This is a small, early-stage trial with only 84 participants. The device is not yet proven for this specific group, and results may not apply to everyone. There is also a risk of device malfunction or low blood sugar.
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
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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
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About 84 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 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 18 years and older 2. Participant has insulin-treated type 2 diabetes on more than 1 insulin injection per day or insulin pump therapy 3. Participant has ESKD and is established on out-patient hospital-based haemodialysis treatment at least 3 times a week, via an arterio-venous fistula, graft or central venous catheter 4. If the participant uses a CGM, the baseline time spent between 3.9 to 10 mmol/L in the last 4 weeks is \<70% 5. For those not using CGM screening HbA1c \>7.0% (53 mmol/mol) and ≤ 12% (108 mmol/mol) 6. Total daily dose of insulin is \> 10 units and \<200 units per day 7. Literate in English for safe study conduct. 8. Willing to wear study glucose sensors and the AID system 9. Willing to follow study-specific instructions 10. Female participants of childbearing age should be on effective contraception, not sexually active / or have no plans for pregnancy 11. All patients whether transplant-wait listed or not, are eligible for inclusion. Exclusion Criteria: Exclusion Criteria 1. Any other physical disease or people with known severe mental illness (psychotic disorder, bipolar disorder, dementia, substance and alcohol dependence, learning disabilities, active suicidal ideation) that are likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator 2. Either current use of peritoneal dialysis or planned modality transfer (transplantation from a live donor with a confirmed date, peritoneal dialysis or conservative care) in the next 18 weeks 3. Only treated with background (basal) insulin 4. The participant is currently on AID or more than 2 weeks use of AID in the last 4 weeks 5. Known or suspected allergy against insulin 6. Treated with sulphonylureas (use of SGLT2 inhibitors are allowed) 7. Treated with hydroxyurea (sensor interference) 8. Presence of unstable retinopathy per Investigator's judgement 9. Severe bilateral visual impairment 10. Pregnancy, planned pregnancy in the next 3 months or breastfeeding current or planned glucocorticoid use other than inhaled/ topical use. Stable long-term steroid use is not an exclusion
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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
4 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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Guys and St Thomas' Hospitals
London, United Kingdom
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Hammersmith Hospital
London, United Kingdom
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Manchester Royal Infirmary
Manchester, United Kingdom
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Royal Derby Hospital
Derby, United Kingdom
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