The effectiveness of insulin administration with an insulin pump using a fully closed-loop system on renal oxygenation in people with type 2 diabetes suffering from moderate chronic kidney disease

Zusammenfassung der Studie

Chronic kidney disease is a common complication of diabetes, affecting up to 40% of diabetic patients. Renal hypoxia is likely involved in the development of diabetic nephropathy. Higher blood sugar levels have been shown to be associated with decreased renal oxygenation. Blood oxygen level-dependent (BOLD) MRI is a new functional imaging technique that allows for non-invasive assessment of renal oxygenation. The administration of insulin in a fully closed-loop system in patients with type 2 diabetes has shown improvement in glycemic control. However, no study has evaluated the effect of a fully closed-loop system on renal function. This study is a randomized controlled trial aimed at assessing the effect of using an insulin pump with a fully closed-loop system on renal function in patients with type 2 diabetes suffering from moderate chronic kidney disease. 76 patients with type 2 diabetes and chronic kidney disease who are receiving insulin treatment will be invited to participate in this study. Half of the participants will be placed on treatment with an insulin pump using a fully closed-loop system and monitored for a duration of 26 weeks. The other half will continue their usual treatment with insulin injections. Renal oxygenation will be assessed at the end of the 26 weeks using BOLD MRI. Patient-reported outcomes will also be evaluated in both groups.

(BASEC)

Untersuchte Intervention

Chronic kidney disease is a common complication of diabetes, affecting up to 40% of diabetic patients. Renal hypoxia is likely involved in the development of diabetic nephropathy. Higher blood sugar levels have been shown to be associated with decreased renal oxygenation. Blood oxygen level-dependent (BOLD) MRI is a new functional imaging technique that allows for non-invasive assessment of renal oxygenation. The administration of insulin in a fully closed-loop system in patients with type 2 diabetes has shown improvement in glycemic control. However, no study has evaluated the effect of a fully closed-loop system on renal function.

This study is a randomized controlled trial aimed at assessing the effect of using an insulin pump with a fully closed-loop system on renal function in patients with type 2 diabetes suffering from moderate chronic kidney disease. 76 patients with type 2 diabetes and chronic kidney disease who are receiving insulin treatment will be invited to participate in this study. Half of the participants will be placed on treatment with an insulin pump using a fully closed-loop system and monitored for a duration of 26 weeks. The other half will continue their usual treatment with insulin injections. Renal oxygenation will be assessed at the end of the 26 weeks using BOLD MRI. Patient-reported outcomes will also be evaluated in both groups.

(BASEC)

Untersuchte Krankheit(en)

Type 2 diabetes, chronic kidney disease

(BASEC)

Sponsor

The Principal Investigator (PI) acts as the Sponsor

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Waadt

(BASEC)

Datum der Bewilligung durch die Ethikkommission

10.04.2025

(BASEC)

Ergebnisse der Studie