Omnipod 5 system for insulin delivery in adults with type 2 diabetes on dialysis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial evaluates the use of the Omnipod 5 automated insulin delivery system in adults with insulin-treated type 2 diabetes and end-stage kidney disease requiring haemodialysis. Participants will use CGMs and the AID system to see if glucose control improves compared with their current regimen. The study focuses on safety and impact on quality of life in a population with highly variable glucose and high hypoglycemia risk. Enrollment includes multiple UK centers with adults on at least three haemodialysis sessions per week. Key eligibility criteria include insulin use, dialysis status, CGM suitability, and language comprehension for study procedures.

Why it matters

Who can join: the full rules

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

Where it's running

• Royal Derby Hospital
  Derby, United Kingdom Recruiting
• Guys and St Thomas' Hospitals
  London, United Kingdom Recruiting
• Hammersmith Hospital
  London, United Kingdom Recruiting
• Manchester Royal Infirmary
  Manchester, United Kingdom Recruiting

Study contacts

• Study coordinator: Lalantha Leelarathna, PhD
• Email: lalantha.leelarathna@nhs.net
• Phone: +44 7984477771

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.