Early Glargine (Lantus) in DKA Management in Children With Type 1 Diabetes
Condition: Diabetic Ketoacidosis; Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1; Ketosis; Diabetic Ketoacidosis
Study type: Interventional
Phase: Phase 4

Summary: 
      A frequent complication in the management of diabetic ketoacidosis (DKA) in children with
      type 1 diabetes is rebound hyperglycemia (blood glucose over 180 mg/dL) which increases the
      risk of re-developing DKA and can lengthen the hospital stay. The investigators want to study
      whether giving the long-acting insulin glargine (Lantus®) early in DKA management (versus
      after complete resolution of the DKA) helps prevent rebound hyperglycemia and makes the
      transition to insulin injections easier. Participants will also have the option to wear a
      continuous glucose monitor (CGM) during the study to help us understand blood glucose control
      during and after DKA.
    

Detailed description: 
      Diabetic ketoacidosis (DKA) remains the leading cause of morbidity and mortality in children
      with type 1 diabetes (T1D) and the incidence of T1D is increasing. A frequent complication in
      DKA management that is associated with in-hospital mortality and longer hospital stay is
      hyperglycemia; specifically rebound hyperglycemia (defined as a serum glucose greater than
      180 mg/dL) within 12-24 hours after correction of the DKA. Rebound hyperglycemia increases
      the patient's risk of re-developing DKA. Few adult studies suggest that giving the
      long-acting insulin analog (glargine or Lantus®) early in the management of DKA (i.e. while
      still receiving intravenous insulin) can reduce rebound hyperglycemia without an increased
      risk of hypoglycemia and result in a smoother transition from intravenous insulin to
      subcutaneous insulin. This has not been well-studied in children to date. In this study the
      investigators want to determine whether giving glargine early in DKA management in children
      results in reduced rebound hyperglycemia without an increased risk in hypoglycemia. The
      investigators will do this by randomizing participants in DKA to either receive glargine
      early in the management of DKA (study group) or after resolution of DKA (control group); the
      latter is currently standard-of-care. Additionally, continuous glucose monitoring (CGM)
      systems have not been studied in a pediatric population with DKA. These devices measure blood
      sugar levels every 5 minutes and provide a great deal of information about blood sugar
      control patterns over many days. Not only will the use of CGM in this study provide
      meaningful information regarding blood sugar patterns during DKA treatment, it will also
      broaden the investigators knowledge of whether CGM is a feasible and accurate tool to use in
      this setting.
    

Intervention name(s): Glargine; Continuous Glucose Monitor (Abbott FreeStyle Libre Pro)
Intervention type(s): Drug; Device
Intervention description(s): A dose of glargine (Lantus) will be given subcutaneously either early in the management of DKA (study group) or upon resolution of DKA (control group).; All participants will be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA in order to better understand blood glucose control during DKA. This is an optional part of the study.
Other intervention name(s): Lantus; CGM
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DKA; type 1 diabetes; children; continuous glucose monitoring