Diabetes Mellitus, Type 1, Diabetic Ketoacidosis
Conditions
Brief summary
The management goals of diabetic ketoacidosis (DKA) in the pediatric type 1 diabetes (T1DM) population are fluid and electrolyte repletion, insulin administration, and correction of acidosis in order to stabilize the patient. Traditionally, a rapid-acting insulin IV infusion is begun immediately and continued until the acidosis is corrected and hyperglycemia normalized. Once the acidosis is corrected, patients are able to be transitioned to a subcutaneous insulin regimen. The role that a subcutaneous long-acting insulin such as glargine has in the acute treatment of DKA has not been extensively studied. While giving glargine during the treatment of DKA is becoming more common place, few studies have examined the potential risks and benefits of its use. This study will investigate the effects of early administration of glargine during DKA in patients with newly diagnosed TIDM. The design of this study is a prospective, double-blind study of children ages 2-21 who are admitted to the hospital in DKA with a diagnosis of T1DM. The control group will receive all traditional methods of treatment for DKA, including a placebo subcutaneous injection. The study group will receive the same treatment, but will be supplemented with a subcutaneous glargine injection.
Interventions
DRUGGlargine
The control group will receive all traditional methods of treatment for DKA, including a placebo subcutaneous injection. The study group will receive the same treatment, but will be supplemented with a subcutaneous glargine injection.
DRUGIV insulin
The intravenous infusion of insulin at a weight-based fixed rate until ketosis has subsided.
OTHERElectrolyte Correction
If the potassium level is greater than 6 mEq/L, do not administer potassium supplement. If the potassium level is 4.5-6 mEq/L, administer 10 mEq/h of potassium chloride. If the potassium level is 3-4.5 mEq/L, administer 20 mEq/h of potassium chloride.
OTHERCorrection of Fluid Loss
Initial correction of fluid loss is either by isotonic sodium chloride solution or by lactated Ringer solution. The recommended schedule for restoring fluids is as follows: * Administer 1-3 L during the first hour. * Administer 1 L during the second hour. * Administer 1 L during the following 2 hours * Administer 1 L every 4 hours, depending on the degree of dehydration and central venous pressure readings
Sponsors
Chattanooga-Hamilton County Hospital Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* T1DM * Hyperglycemia \>200 mg/dl * Bicarbonate ≤ 15 mmol/L * pH \< 7.3 * Ketonemia * Ketonuria * Glucosuria * Admission to PICU (Pediatric Intensive Care Unit) * Ages 1-21 years
Exclusion criteria
* Patients who received glargine within the last 24 hours * Patients with sepsis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose | Within 3 hrs of arrival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood pH | within 3 hours of arrival | — |
| Blood glucose | 4 hours after intervention initiation | checking for changes in levels after intervention initiation |
| blood bicarbonate level | Within 3 hrs of arrival | — |
| Urinalysis for levels of ketones & glucosuria | Within 3 hrs of arrival | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemic events | length of hospital stay, an expected average of 3 days | Hypoglycemia is defined as blood glucose less than 70 mg/dL. |
| Length of Hospital Stay | 1-5 days | — |
| Length of PICU Stay | 1-2 days | — |
Countries
United States
Outcome results
None listed