Type 1 Diabetes Mellitus Clinical Trial
Official title:
An Open-label, Double-blind, Randomized, Two-way, Cross-over Pilot Study to Provide Preliminary Evidence of the Efficacy of Rapid-acting Aspart Compared to Faster Acting Aspart Within the Context of Single-hormone Closed-loop Strategy at Regulating Postprandial Glucose Levels in Adults With Type 1 Diabetes
Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,
insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required
insulin dosages based on the sensor's readings.
The objective of this pilot study is to inform both the decision whether to conduct a
confirmatory study and the design of the larger confirmatory trial. In addition, we want to
estimate postprandial glucose levels parameters and confidence interval in an 11-hour
in-patient study with standardized conditions in adults with type 1 diabetes, estimate the
size and direction of the treatment effect.
Faster insulin Aspart (FiAsp) will provide preliminary evidence of efficacy to regulate
postprandial glucose levels compared to rapid-acting Aspart in adults with type 1 diabetes
using insulin pump therapy.
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