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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:

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Study Design


Intervention

Drug:
Rapid-Acting Insulin
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)
Long acting insulin
Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)

Locations

Country Name City State
United States Children's Healthcare of Atlanta Atlanta Georgia

Sponsors (1)

Lead Sponsor Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of All Consented Participants The capacity for recruitment was assessed, including all subjects that signed the Informed Consent Form (ICF). 4 months post-intervention
Primary Number of Participants That Completed All Visits Number of participants that were able to complete all study visits, including the visits in-person at 1 month and 4 months post-randomization. 4 months post-intervention
Primary Caregiver Treatment Adherence at 1 Month and 4 Months Post-intervention Caregiver treatment adherence was assessed using a blood glucose log. Subjects and caregivers recorded blood glucose levels and the amount/type of insulin given. This data was used to calculate adherence as a percentage ranging from 0% (no adherence) to 100% (full adherence). 1 month post-intervention and 4 months post-intervention
Secondary Caregiver Anxiety Caregiver anxiety was measured with the "parental stress scale". Caregivers completed the "parental stress scale" at initial enrollment and at each clinic follow up visit. The Parental Stress Scale includes 18 questions that are rated from 1 (strongly disagree) to 5 (strongly agree). Scoring ranges from 18 - 90. The higher the score, the higher the stress and anxiety level. Baseline, 1 month post-intervention, 4 months post-intervention
Secondary Glycemic Variability (GV) at 1 Month and 4 Months Post-intervention The GV was calculated in all subjects using the average blood glucose levels collected from the daily blood glucose paper log. A subjective qualification system was used to label each subject's GV based on their blood glucose levels and an established glucose monitoring (GM) data system. Subjects are considered to have appropriate GV if their blood glucose levels are in the range of 80 mg/dL - 180 mg/dL. Percentage of participants within each specific average BG range is shown. 1 month post-intervention, 4 months post-intervention
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