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

NCT ID: NCT04157738

Last Updated: 2021-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-27
• Study Completion Date: 2020-12-17

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.

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.

Conditions

Diabetes Mellitus; Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fixed Group

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.

Group Type: EXPERIMENTAL

Rapid-Acting Insulin

Intervention Type: 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)

Long acting insulin

Intervention Type: DRUG

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

Insulin to carbohydrate ratio (ICR) Group

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

Group Type: ACTIVE_COMPARATOR

Rapid-Acting Insulin

Intervention Type: 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)

Long acting insulin

Intervention Type: DRUG

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

Interventions

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)

Intervention Type: DRUG

Long acting insulin

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

Intervention Type: DRUG

Other Intervention Names

Lispro, Aspart, glulisine; Glargine

Eligibility 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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Eric Felner, MD, MSCR

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric I Felner, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36617389 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00114078

Identifier Type: -

Identifier Source: org_study_id