Type 1 Diabetes Clinical Trial
Official title:
A Single-blind, Randomized, Two-way, Cross-over Study to Examine the Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation Combined With a Simplified Qualitative Meal-size Estimation in Adults With Type 1 Diabetes
In previous studies, investigators have studied if a pre-meal insulin bolus based on
estimated carbohydrate meal size would alleviate the burden of carbohydrate counting without
a significant degradation in postprandial glucose control. With this strategy, the patient
would only have to evaluate the size of the meal in terms of carbohydrate (snack, regular,
large or very large) It is however important to establish safety of this simplified meal
bolus approach. The safety of overestimating a meal insulin bolus in the context of single
and dual-hormone CLS with the simplified meal strategy needs to be determined. Computer
simulation will be used to get a reasonable estimate of risks related to over-estimation
with single-hormone closed-loop while over-estimation with dual-hormone closed-loop will be
tested in adults with type 1 diabètes
Investigators hypothesize that dual-hormone closed-loop with overestimated meal size bolus
will not increase time below 4.0 mmol/L compared to dual-hormone closed-loop with an
adequately estimated meal size bolus
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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