Early Glargine (Lantus) in DKA Management in Children With Type 1 Diabetes

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.

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.