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Safety and Effectiveness of the Luna System in People With Type 1 Diabetes Mellitus

Luna Diabetes · 2024
ClinicalTrials.gov · Datasets · License: Public Domain · 2024
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nasleep-qualitytype-1-diabetestype-1-diabetes-mellitus
The purpose of this research is to evaluate the effect of a wearable insulin pump on blood sugar levels during sleep. The study device works with continuous glucose monitors (CGM) to calculate and deliver rapid-acting insulin doses during sleep. The study device does not replace long-acting, correction, or mealtime insulin. The study will involve applying the study device before bed for a period of 13 weeks. The overall study length is approximately 17 weeks. The study aims to evaluate whether the study device is safe and if it lowers blood sugar levels in people who have consistently high blood sugar during sleep and at wake.
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