Condition: Type 2 Diabetes · Chronic Kidney Disease Stage 3 · Sponsor: Heba Al-Alwan
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 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.
This description comes directly from the study's public registry record.
Heba Al-Alwan, MD, PhD · +4179 556 27 98 · heba.al-alwan@chuv.ch
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| Centre Hospitalier Universitaire Vaudois | Lausanne, Canton of Vaud, Switzerland | Not Yet Recruiting |
| CHUV | Lausanne, Switzerland | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06925217