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

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ClinicalTrials.gov Identifier: NCT04157738
Recruitment Status : Enrolling by invitation
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Eric Felner, MD, MSCR, Emory University

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 1 Diabetes Drug: Rapid-Acting Insulin Drug: Long acting insulin Phase 4

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) Evening 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fixed Dose for Fixed Carbohydrates vs. Variable Dosing for Variable Carbohydrates: A Study of Rapid-Acting Mealtime Insulin in Children and Adolescents With Newly Diagnosed Type 1 Diabetes Mellitus.
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: 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.
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)
Other Name: Lispro, Aspart, glulisine

Drug: Long acting insulin
Prior to discharge, all subjects will receive a regimen that includes an evening dose of long-acting insulin (Glargine)
Other Name: Glargine

Active Comparator: 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
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)
Other Name: Lispro, Aspart, glulisine

Drug: Long acting insulin
Prior to discharge, all subjects will receive a regimen that includes an evening dose of long-acting insulin (Glargine)
Other Name: Glargine




Primary Outcome Measures :
  1. Number of all consented participants [ Time Frame: 4 months post-intervention ]
    The capacity for recruitment will be assessed, including all subjects that signed the Informed Consent Form (ICF).

  2. Number of participants that completed all visits [ Time Frame: 4 months post-intervention ]
    Number of participants that were able to complete all study visits, including the visits in-person at 1 month and 4 months post-randomization.

  3. Change in caregiver treatment adherence [ Time Frame: Baseline, 1 month post-intervention, 4 months post-intervention ]
    Caregiver treatment adherence will be assessed using a blood glucose log. Subjects and caregivers will record blood glucose levels and the amount/type of insulin given. This data will be used to calculate adherence as a percentage ranging from 0% (no adherence) to 100% (full adherence).


Secondary Outcome Measures :
  1. Change in caregiver anxiety [ Time Frame: Baseline, 1 month post-intervention, 4 months post-intervention ]
    Caregivers will complete 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 level.

  2. Change in Glycemic Variability (GV) [ Time Frame: 1 month post-intervention, 4 months post-intervention ]
    The GV will be calculated in all subjects using the average blood glucose levels collected from the daily blood glucose paper log. A subjective qualification system will be used to label each subject's GV based on their blood glucose levels and an established glucose monitoring (GM) data system. Subjects will be considered to have appropriate GV if their blood glucose levels are in the range of 80 mg/dL - 180 mg/dL.



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Ages Eligible for Study:   8 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have Confirmed diagnosis of T1DM based on the most recent ADA criteria
  • Be 8 - 14 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04157738


Locations
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United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Eric I Felner, MD Emory University

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Responsible Party: Eric Felner, MD, MSCR, Professor, Emory University
ClinicalTrials.gov Identifier: NCT04157738     History of Changes
Other Study ID Numbers: IRB00114078
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Eric Felner, MD, MSCR, Emory University:
Diabetes
Glycemic variability
Insulin
Parental Stress
Advanced carbohydrates counting
Insulin for meals
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin, Short-Acting
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs