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: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Insulin; Insulin, Globin Zinc; Insulin, Long-Acting; Insulin, Short-Acting

Criteria

Inclusion Criteria:

• Have Confirmed diagnosis of T1DM based on the most recent ADA criteria

• Be 7 - 15 years of age

• Begin monitoring with a glucose monitor prior to discharge from the hospital

• Have the ability to understand and be willing to adhere to the study protocol

• English or Spanish speakers

Exclusion Criteria:

• Have a clinically significant major organ system disease

• Be on glucocorticoid therapy

• Have Type 2 Diabetes Mellitus

• Have Polycystic Ovarian Syndrome (PCOS)

• Have a BMI > 85th %ile

• Have Acanthosis Nigricans

• Have any form of renal impairment

• Have Cystic Fibrosis

• Have Glucocorticoid-, Chemotherapeutic-, or any other Medication-induced form of Diabetes

• Be using any basal insulin other than Glargine insulin

• Have cognitive impairment (> 2 grades behind age-appropriate grade in school)

• Be in Foster Care

• Have any history of Division of Family and Children Services (DFCS) involvement

• If female, be pregnant or breast-feeding.