Type 2 Diabetes (T2D) Clinical Trials

Find Type 2 Diabetes (T2D) Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Imperial College Healthcare NHS Trust
RECRUITING
London
Contact Information
Primary
Lalantha Leelarathna, FRCP PhD
e.leelarathna@imperial.ac.uk
+447984477771
Backup
Nick Oliver, FRCP PhD
nick.oliver@imperial.ac.uk
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2027-02-01
Participants
Target number of participants: 12
Treatments
Experimental: Automated insulin delivery using Medtronic 780G System
Other: Usual care plus continuous glucose monitoring
Sponsors
Leads: Imperial College London

This content was sourced from clinicaltrials.gov