Clinical trial NCT02548494: Early Administration of Long-acting Insulin Treatment of Diabetic Ketoacidosis in Pediatric Type 1 Diabetes
Official title: Early Administration of Long-acting Insulin Glargine for the Treatment of Diabetic Ketoacidosis in Pediatric Type 1 Diabetes: A Randomized Double Blind Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Diabetic Ketoacidosis
Lead sponsor: Chattanooga-Hamilton County Hospital Authority
Sponsor class: OTHER
First posted: 2015-09-14
Enrollment: 17
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Blood glucose
timeFrame: Within 3 hrs of arrival
Secondary outcomes:
measure: Blood glucose
timeFrame: 4 hours after intervention initiation
measure: blood pH
timeFrame: within 3 hours of arrival
measure: blood pH
timeFrame: 4 hours after intervention initiation
measure: blood bicarbonate level
timeFrame: Within 3 hrs of arrival
measure: blood bicarbonate level
timeFrame: 4 hours after intervention initiation
measure: Urinalysis for levels of ketones & glucosuria
timeFrame: Within 3 hrs of arrival
measure: Urinalysis for levels of ketones & glucosuria
timeFrame: 4 hours after intervention initiation
Other outcomes:
measure: Length of PICU Stay
timeFrame: 1-2 days
measure: Length of Hospital Stay
timeFrame: 1-5 days
measure: Hypoglycemic events
timeFrame: length of hospital stay, an expected average of 3 days
Locations:
city: Chattanooga
country: United States
facility: Children's @ Erlanger
state: Tennessee
Study officials:
affiliation: UTCOMC/ Children's at Erlanger
name: Rita Shridharani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levitsky LL et al. Epidemiology, presentation, and diagnosis of type 1 diabetes mellitus in children and adolescents. In: UpToDate, Wolfsdorf J (Ed), UpToDate, Waltham, MA. (Accessed on November 3, 2014.)
citation: Jeha GS, Haymond Mw. Treatment and complications of diabetic ketoacidosis in children. In: UpToDate, Waltham MA. (Accessed on November 4, 2014.)
citation: Urakami T, Naito Y, Seino Y. Insulin glargine in pediatric patients with type 1 diabetes in Japan. Pediatr Int. 2014 Dec;56(6):822-828. doi: 10.1111/ped.12379. Epub 2014 Sep 16.
citation: Shankar V, Haque A, Churchwell KB, Russell W. Insulin glargine supplementation during early management phase of diabetic ketoacidosis in children. Intensive Care Med. 2007 Jul;33(7):1173-1178. doi: 10.1007/s00134-007-0674-3. Epub 2007 May 17.
citation: Hsia E, Seggelke S, Gibbs J, Hawkins RM, Cohlmia E, Rasouli N, Wang C, Kam I, Draznin B. Subcutaneous administration of glargine to diabetic patients receiving insulin infusion prevents rebound hyperglycemia. J Clin Endocrinol Metab. 2012 Sep;97(9):3132-7. doi: 10.1210/jc.2012-1244. Epub 2012 Jun 8.
citation: 6Lexicomp online