A Study of Rapid-Acting Mealtime Insulin in Children and Adolescents With Newly Diagnosed Type 1 Diabetes Mellitus
Status:
Completed
Trial end date:
2020-12-17
Target enrollment:
Participant gender:
Summary
Type 1 diabetes mellitus (T1DM) is a challenging medical disorder, especially in children and
adolescents. In order to prevent the chronic complications of hyperglycemia, the maintenance
of near-normal glycemic control must be balanced with minimizing hypoglycemia. Although many
pediatric endocrinologists provide an ICR plan for their newly diagnosed patients with T1DM,
fixed dosing and other forms of insulin delivery are available. This proposal is designed to
compare children and adolescents with newly diagnosed T1DM using a fixed insulin dose for
fixed carbohydrate mealtime regimen (FIXED group) to children and adolescents with newly
diagnosed T1DM using an ICR with variable carbohydrate intake (ICR group) mealtime regimen.
In addition to determining the feasibility for a subsequently larger clinical trial, the aims
of this investigator-initiated, prospective proposal, is twofold. The first is to determine
if the caregivers of diabetics using a fixed insulin for fixed carbohydrate regimen (FIXED
group) experience less anxiety than the caregivers of those using an ICR with variable
carbohydrate intake regimen (ICR group) at 1- and 4-months post-randomization. The second is
to determine if diabetics utilizing a fixed insulin for fixed carbohydrate regimen (FIXED
group) have decreased glycemic variability (GV) than those using an ICR with variable
carbohydrate intake regimen (ICR group) at 1- and 4-months post-randomization.