A Study of Rapid-Acting Mealtime Insulin in Children and Adolescents With Newly Diagnosed Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus; Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Although children and adolescents with T1DM have much more freedom with the amount of food
      (carbohydrates) they eat while using an ICR at mealtime, the difficulty in determining the
      amount of insulin needed, how and when to adjust the ICR, the difficulty with understanding
      the basics of managing T1DM, and the adaptation to a new lifestyle with T1DM may be more
      complicated than utilizing a simple plan that includes a fixed amount of insulin and fixed
      number of carbohydrates, at least for the first few months after diagnosis. As complicated as
      it is for children, adolescents, and their caregivers to learn how to manage T1DM after being
      discharged home in usually < 48 hours after diagnosis, a more simplified insulin regimen at
      mealtime may provide the family of and the child or adolescent with newly diagnosed T1DM with
      less stress and anxiety while still maintaining adequate glycemic control. Twenty - 40
      subjects will be recruited at Children's Hospital of Atlanta (CHOA) at Egleston and will be
      randomized to either the FIXED group or the ICR group according to a computer-generated
      random sampling table. The subject and his/her caregivers will receive diabetes education
      while in the hospital in standard fashion. The subject and his/her caregivers will receive
      glucose monitoring education and training prior to hospital discharge. The subject and
      his/her caregivers will also receive a paper log to record the blood sugars, number of
      carbohydrates consumed and insulin administered at each meal throughout the day.

      Prior to discharge, all subjects will receive a regimen that includes a: 1) Meal-time insulin
      and carbohydrate regimen (# of units of insulin, # of carbohydrates, and/or ICR); 2) Daily
      dose of Glargine; 3) Hyperglycemia correction regimen for blood glucose levels > 199 mg/dL;
      and 4) Hypoglycemia treatment regimen for blood glucose levels < 70 mg/dL and/or symptomatic.

      As per standard diabetes care, caregivers will report all blood glucose levels every day (to
      the study investigators) until the subject's initial clinic visit 4-6 weeks after diagnosis.
      All insulin adjustments will be made by the study investigators.

      After the subject's first clinic visit, caregivers will contact the study investigators once
      a week to report blood glucose levels and the investigators will make adjustments as needed.

      All the diabetes clinic visits will occur at the Center for Advanced Pediatrics (CAP),
      approximately three miles from CHOA-Egleston Hospital. Subjects will attend clinic with one
      or more of the investigators approximately 1 and 4 months after enrollment.

      At each clinic visit, subjects (and their caregivers) will answer standard diabetes
      questions, subjects will undergo a physical examination, and subjects' objective data (vital
      signs, glucose meter (GM) data, insulin dosing, and carbohydrate intake) will be collected by
      the study personnel.
    

Intervention name(s): Rapid-Acting Insulin; Long acting insulin
Intervention type(s): Drug; Drug
Intervention description(s): Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR); Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
Other intervention name(s): Lispro, Aspart, glulisine; Glargine
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin, Short-Acting; Insulin, Long-Acting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Glycemic variability; Insulin; Parental Stress; Advanced carbohydrates counting; Insulin for meals