Early Administration of Long-acting Insulin Treatment of Diabetic Ketoacidosis in Pediatric Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02548494
• Other study ID #: 15-Lantus
• Status: Terminated
• Phase: N/A
• Start date: November 2015
• Est. completion date: February 1, 2019

Study information

• Verified date: September 2020
• Source: Chattanooga-Hamilton County Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Acidosis
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetic Ketoacidosis
• Ketosis

Intervention

Drug:
• Glargine
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.
• IV insulin
The intravenous infusion of insulin at a weight-based fixed rate until ketosis has subsided.

Other:
• Electrolyte 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.
• Correction 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

Locations

Country	Name	City	State
United States	Children's @ Erlanger	Chattanooga	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Chattanooga-Hamilton County Hospital Authority

Country where clinical trial is conducted

United States, 

References & Publications (6)

6Lexicomp online

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. — View Citation

Jeha GS, Haymond Mw. Treatment and complications of diabetic ketoacidosis in children. In: UpToDate, Waltham MA. (Accessed on November 4, 2014.)

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.)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of PICU Stay		1-2 days
Other	Length of Hospital Stay		1-5 days
Other	Hypoglycemic events	Hypoglycemia is defined as blood glucose less than 70 mg/dL.	length of hospital stay, an expected average of 3 days
Primary	Blood glucose		Within 3 hrs of arrival
Secondary	Blood glucose	checking for changes in levels after intervention initiation	4 hours after intervention initiation
Secondary	blood pH		within 3 hours of arrival
Secondary	blood pH	checking for changes in levels after intervention initiation	4 hours after intervention initiation
Secondary	blood bicarbonate level		Within 3 hrs of arrival
Secondary	blood bicarbonate level	checking for changes in levels after intervention initiation	4 hours after intervention initiation
Secondary	Urinalysis for levels of ketones & glucosuria		Within 3 hrs of arrival
Secondary	Urinalysis for levels of ketones & glucosuria	checking for changes in levels after intervention initiation	4 hours after intervention initiation