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
Summary description of the study
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)
Intervention under investigation
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)
Disease under investigation
Type 2 diabetes, chronic kidney disease
(BASEC)
Type 2 diabetes Chronic kidney disease stage III Insulin treatment (BASEC)
Exclusion criteria
Type 1 diabetes Contraindication to perform an MRI Two episodes of hypoglycemia in the last six months (BASEC)
Trial sites
Lausanne
(BASEC)
Sponsor
The Principal Investigator (PI) acts as the Sponsor
(BASEC)
Contact
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Vaud
(BASEC)
Date of authorisation
10.04.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
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 (CLICK study) (BASEC)
Academic title
not available
Public title
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Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available