At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Acute Effect of a Mixed Meal With and Without Extra Insulin on Arterial Stiffness, a Prospective Randomized Study.
In Brief
An observational study evaluating Pre-meal bolus and No meal bolus for Arterial Stiffness in Youth With Type 1 Diabetes. Completed, enrolled 60 participants across 1 site.
Detailed Summary
Using radial artery tonometry to study arterial stiffness, the plan is to study a cohort of 65 children with Type I diabetes mellitus. This prospective, crossover study will help determine if there is an acute increase in arterial stiffness in children with Type I diabetes mellitus who do not give extra insulin to cover a meal. This will give more support to show why it is so critical to bolus every time they eat and to bolus on time to decrease cardiovascular consequences of poorly controlled diabetes. The hypothesis is that giving insulin before a meal compared to not giving insulin before a meal will be associated with lower arterial stiffness in children with type I diabetes.
Study Details
Timeline
Interventions
Long acting insulin as scheduled per usual routine PLUS rapid/ short acting (bolus) prior to Boost
Long Acting insulin as scheduled per usual routine (given once daily)