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
Intervention: Glargine; Continuous Glucose Monitor (Abbott FreeStyle Libre Pro)
Intervention description: 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.
Intervention MeSH terms: Insulin Glargine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: DKA; type 1 diabetes; children; continuous glucose monitoring

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 6-17.9 years at time of enrollment.

          2. Known history of type 1 diabetes or presumed new-onset type 1 diabetes.

          3. Diagnosis of DKA (serum glucose or fingerstick glucose concentration ≥ 200 mg/dL.

          4. Venous pH ≤7.3 and/or serum bicarbonate concentration ≤15 mmol/L.

          5. Evidence of ketonemia or ketonuria).

        Exclusion Criteria:

          1. Participants who present in DKA with conditions that affect neurological function such
             as:

               1. suspected alcohol or drug use,

               2. severe head trauma,

               3. meningitis, etc., who would not be able to consent/assent for the study.

          2. Participants who present in DKA who are showing signs of altered mental status at time
             of enrollment.

          3. Other known complicating illness or poorly-controlled chronic illness that is known to
             affect blood glucose levels and/or electrolyte balance such as:

               1. chronic renal disease (requiring hemodialysis),

               2. chronic liver disease (with evidence of current hepatic dysfunction,

               3. coagulopathy, and/or chronic hepatitis), or

               4. severe chronic lung disease (requiring the use of oral steroids).

          4. Use of medications that are known to affect blood glucose levels such as:

               1. oral glucocorticoids,

               2. Metformin,

               3. SGLT2 inhibitors,

               4. GLP-1 receptor agonists,

               5. DPP-4 inhibitors,

               6. thiazolidinediones

               7. sulfonylureas, and

               8. vasopressors, etc.

          5. Participants who have begun DKA treatment prior to being approached for enrollment and
             have received more than 6 hours of IV insulin therapy.

          6. Participants who are known to be pregnant.

          7. Participants who have a known diagnosis of type 2 diabetes.

          8. Participants for whom the treating physicians feel a specific insulin regimen is
             necessary such that patient safety or well-being could be compromised by enrollment
             into the study.