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New treatment option for Chronic Kidney Diseases
Official title Automated Insulin Delivery in Adults With Advanced Kidney Disease
ClinicalTrials.gov ID: NCT06463483
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- 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.
You likely can't join if
- 1\. The participant is already using an AID system
- 2\. The participant is treated with sulphonylureas (SGLT2 inhibitors, metformin, and GLP1 analogues may be used within regulatory guidelines) in...
- 3\. The participant has a recent history of diabetic ketoacidosis (\<6 months)
- 4\. The use of systemic steroid therapy within the past four weeks (stable doses of steroids for \>8 weeks permitted)
- 5\. The participant has significant cognitive impairment or major psychiatric history affecting safe study conduct
- 6\. Known significant allergy to tape/ adhesives
See the full eligibility criteria
- 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
- 1\. The participant is already using an AID system
- 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...
- 3\. The participant has a recent history of diabetic ketoacidosis (\<6 months)
- 4\. The use of systemic steroid therapy within the past four weeks (stable doses of steroids for \>8 weeks permitted)
- 5\. The participant has significant cognitive impairment or major psychiatric history affecting safe study conduct
- 6\. Known significant allergy to tape/ adhesives
- 7\. Women who are pregnant or planning pregnancy
- 8\. The participant has an active major life-threatening illness limiting the participants life expectancy to \<6 months
- 9\. The participant is on hydroxyurea treatment or taking regular / daily paracetamol treatment (sensor interference)
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.