A Study of Rapid-Acting Mealtime Insulin in Children and Adolescents With Newly Diagnosed Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus; Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Rapid-Acting Insulin; Long acting insulin
Intervention description: 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); Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin, Short-Acting; Insulin, Long-Acting
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 7 Years
Maximum age: 15 Years
Healthy volunteers: No
Keywords: Diabetes; Glycemic variability; Insulin; Parental Stress; Advanced carbohydrates counting; Insulin for meals

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.
    

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.