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
Résumé de l'étude
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 étudiée
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)
Maladie en cours d'investigation
Type 2 diabetes, chronic kidney disease
(BASEC)
Type 2 diabetes Chronic kidney disease stage III Insulin treatment (BASEC)
Critères d'exclusion
Type 1 diabetes Contraindication to perform an MRI Two episodes of hypoglycemia in the last six months (BASEC)
Lieu de l’étude
Lausanne
(BASEC)
Sponsor
The Principal Investigator (PI) acts as the Sponsor
(BASEC)
Contact pour plus d'informations sur l'étude
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique du Vaud
(BASEC)
Date d'approbation du comité d'éthique
10.04.2025
(BASEC)
Identifiant de l'essai ICTRP
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Titre officiel (approuvé par le comité d'éthique)
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)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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