Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04157738 |
| Other study ID # |
IRB00114078 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
November 27, 2019 |
| Est. completion date |
December 17, 2020 |
Study information
| Verified date |
September 2021 |
| Source |
Emory University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
