NCT06463483Toboroz

Automated Insulin Delivery in Adults With Advanced Kidney Disease

Glucose Control With Medtronic 780G System in Adults With Diabetes and Advanced Renal Disease

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jan. 8.

Rövid összefoglaló (regiszter, angolul)

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 hard, with fluctuating glucose levels and an increased risk of unsafe low glucose levels. There are currently 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 deliver insulin automatically to control glucose. 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 automated insulin delivery can improve glucose levels and quality of life in people with diabetes treated with more than one insulin injection with advanced kidney failure and/or undergoing regular dialysis treatment. This study will be a feasibility study conducted in a single centre (Imperial College, London) and be of a cross-over design. The study will aim to complete 12 people. Participants will wear a glucose sensor at the start. In random order, half will start AID followed by the usual treatment, while the other half will start the usual treatment followed by AID treatment. The duration of each treatment stage is eight weeks. The study will last about 22 weeks for each participant. Investigators will compare the glucose levels in the AID group with the usual care group to see if there is a difference. Questionnaires and interviews will help us understand participants' experiences. Investigators will carefully monitor the safety of participants.

Állapot (regiszter): Toboroz
Vizsgálattípus: Beavatkozással járó
Résztvevők száma: 12 (tervezett)
Első benyújtás: 2024. jún. 10.
Kezdés: 2025. nov. 1.
Elsődleges befejezés: 2026. dec. 30.
Fő szponzor: Imperial College London
Betegségek: Krónikus vesebetegség
NCT-szám: NCT06463483

Mit vállalsz

Vizsgálat típusa: Beavatkozással járó
Tervezett résztvevők: 12
2025. nov. 1. és az elsődleges befejezés (2026. dec. 30.) között
1 helyszín, 1 országban
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Korábbi kezelés

4. The use of systemic steroid therapy within the past four weeks (stable doses of steroids for >8 weeks permitted)

Más betegség

3. The participant has a recent history of diabetic ketoacidosis (<6 months)
5. The participant has significant cognitive impairment or major psychiatric history affecting safe study conduct
6. Known significant allergy to tape/ adhesives
8. The participant has an active major life-threatening illness limiting the participants life expectancy to <6 months

Laborértékek

2. The participant is treated with sulphonylureas (SGLT2 inhibitors, metformin, and GLP1 analogues may be used within regulatory guidelines) in pre-dialysis participants (Group A). In Groups B \& C, noninsulin glucose-lowering therapies are not permitted, with the exception of GLP1 agonists used in preparation for transplantation

Egyéb

1. The participant is already using an AID system
7. Women who are pregnant or planning pregnancy
9. The participant is on hydroxyurea treatment or taking regular / daily paracetamol treatment (sensor interference)

Kiket keres a vizsgálat

1. Age 18-70 years inclusive
2. Type 1 diabetes of at least 1-year duration or insulin-requiring type 2 diabetes managed with multiple daily injections (MDI [ie separate rapid-acting and basal insulin injections]) or insulin pump therapy (CSII)
3. The HbA1c <10.5% (<91 mmol/mol)
4. The total daily dose of insulin <200Units
5. The participant is willing and able to implement the study requirements.
6. Participant has advanced renal disease (Group A: Stage 3b or greater renal failure (eGFR <45millilitres/minute/1.73m2); Group B: ESKD requiring peritoneal dialysis; Group C: ESKD requiring haemodialysis
7. Participants (and carer where applicable) should be able to speak and understand English sufficiently for safe study conduct
8. The participant has internet or smartphone access, enabling upload of the 780G system data to cloud-based software

Életkor a regiszterben: 18 év – 70 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

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Helyszín	Város	Ország	Helyszín állapota
Imperial College Healthcare NHS Trust	London	Egyesült Királyság	Toboroz

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