The Effect of Fully Closed-loop Insulin Delivery on Renal Oxygenation in People With Type 2 Diabetes and Chronic Kidney Disease: an Open-label, Single-center, Randomized Two-arm Parallel Trial
The main objective of this study is to evaluate the effect of fully automated closed-loop glucose control on renal tissue oxygenation among people with type 2 diabetes and stage 3 chronic kidney disease. This is a single-center, open-label parallel design study that will compare 26 weeks of fully-automated closed-loop glucose control with standard insulin therapy and continuous glucose monitoring, following a run-in period. A total of up to 76 adults with type 2 diabetes and chronic kidney disease will be recruited through outpatient diabetes and nephrology clinics. The primary outcome is renal tissue oxygenation measured using blood oxygenation level-dependent magnetic resonance imaging at 26 weeks. Other key outcomes include glycated hemoglobin at 26 weeks and time spent with glucose levels within and above the target glucose range (3.9-10.0mmol/L). Other glycemic and renal outcomes (including renal function) will also be assessed, as well as patient-reported outcome measures using validated questionnaires. Safety evaluations include severe hypoglycemic episodes and other adverse and serious adverse events.
• Age 18 years and older
• Type 2 diabetes diagnosed for at least 12 months
• Treatment with insulin therapy for at least 6 months
• Stage 3 CKD (eGFR 30-59 ml/min/1.73m²) for at least 6 months
• HbA1c \< 12% based on venous blood sample from the screening visit
• Receiving treatment with an SGLT2 inhibitor and/or GLP-1 receptor agonist for at least 3 months, have been offered these therapies previously, or contraindication/intolerance to receiving these therapies
• Willing to wear study devices and follow study instructions
• Capable of giving an informed consent