Type 1 Diabetes Clinical Trial
Official title:
Continuous Glucose Sensing at the Site of Subcutaneous Insulin Administration: Evaluation of a Novel Single-Port Treatment Approach in Type 1 Diabetic Patients During a 1-Day Stay in a Clinical Research Center and a 6-Day Period at Home
The study seeks to evaluate a novel treatment approach for performing continuous real-time glucose sensing and insulin delivery at the same subcutaneous tissue site.
The treatment of type 1 diabetes usually comprises the measurement of glucose in blood
obtained by finger pricking and the administration of insulin via subcutaneous bolus
injection or continuous subcutaneous infusion.
This study seeks to test a new treatment approach where glucose sensing and insulin
administration are combined and performed at a single subcutaneous tissue site (single-port
treatment approach). A single-port device consisting of a continuous glucose sensor and an
insulin infusion cannula is inserted into the subcutaneous tissue of 10 type-1 diabetes
patients and used for insulin infusion and simultaneous glucose sensing over a 7-day period.
The performance of the single-port device is assessed by comparing the obtained glucose
readings with those of a blood glucose meter and an additionally worn control sensor.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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