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A Multi-centre Trial to Assess the Efficacy and Safety of the Omnipod 5 System in People With Type 2 Diabetes Undergoing Haemodialysis

RecruitingNAAges 18 Years - anyAllImperial College London
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In plain words

What the trial is, and whether it could suit you

Diabetes is the leading cause of kidney failure in the UK. Many people with diabetes and advanced kidney failure inject themselves with insulin and do finger-prick blood glucose tests. Managing diabetes in people with advanced kidney disease is challenging, with fluctuating glucose levels and an increased risk of unsafe low glucose levels. We now have continuous glucose monitors (CGM), which allow people to monitor glucose without painful fingerprick tests. CGM can be combined with insulin pumps to create automated insulin delivery systems (AID) that automatically deliver insulin to control glucose levels. AID systems are currently used in people with type 1 diabetes, but they are not used in people with type 2 diabetes. There is little information on how these systems might help people with diabetes and advanced kidney failure, and on dialysis. This study will investigate whether autom

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค 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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What it tests

  • Omnipod 5
  • Insulin injections
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Where

4 sites
Royal Derby Hospital
Derby, United Kingdom
Guys and St Thomas' Hospitals
London, United Kingdom
Hammersmith Hospital
London, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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