A Study of Rapid-Acting Mealtime Insulin in Children and Adolescents With Newly Diagnosed Type 1 Diabetes Mellitus

NCT04157738 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB00114078
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus; Type 1 Diabetes

Keywords

Diabetes; Glycemic variability; Insulin; Parental Stress; Advanced carbohydrates counting; Insulin for meals

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Caregiver Anxiety

  Baseline, 1 month post-intervention, 4 months post-intervention

• Glycemic Variability (GV) at 1 Month and 4 Months Post-intervention

  1 month post-intervention, 4 months post-intervention

Study Arms (2)

Fixed Group

EXPERIMENTAL

Children and adolescents with newly-diagnosed T1DM will receive a fixed mealtime carbohydrate with a fixed mealtime insulin dose, that is a simplified regimen that provides a set amount of insulin for a set amount of carbohydrates, and ensures that each dose and each meal is consistent.

Drug: Rapid-Acting Insulin; Drug: Long acting insulin

Insulin to carbohydrate ratio (ICR) Group

ACTIVE COMPARATOR

Children and adolescents with newly-diagnosed T1DM will receive an Insulin to carbohydrate ratio (ICR) with variable carbohydrate intake mealtime regimen

Drug: Rapid-Acting Insulin; Drug: Long acting insulin

Interventions

Rapid-Acting Insulin DRUG

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)

Also known as: Lispro, Aspart, glulisine

Fixed Group; Insulin to carbohydrate ratio (ICR) Group

Long acting insulin DRUG

Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)

Also known as: Glargine

Fixed Group; Insulin to carbohydrate ratio (ICR) Group

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• Diaz JVR, Figueroa J, Felner EI. A pilot study of mealtime insulin administration and parental stress in youth with new-onset type 1 diabetes. Diabet Med. 2023 Apr;40(4):e15039. doi: 10.1111/dme.15039. Epub 2023 Jan 19.

  PMID: 36617389 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Insulin Resistance

Interventions

Insulin, Short-Acting; Insulin Lispro; Insulin Aspart; Insulin, Long-Acting; Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Eric Felner
• Organization: Emory University

efelner@emory.edu

404-727-7651

Study Officials

• Eric I Felner, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 8, 2019
• Study Start: November 27, 2019
• Primary Completion: December 17, 2020
• Study Completion: December 17, 2020
• Last Updated: September 30, 2021
• Results First Posted: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)