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

NCT02548494 | Terminated

• 1 other identifier: 15-Lantus
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1; Diabetic Ketoacidosis

Outcome Measures

Primary Outcomes (1)

• Blood glucose

  Within 3 hrs of arrival

Secondary Outcomes (7)

• Blood glucose

  4 hours after intervention initiation

• blood pH

  within 3 hours of arrival

• blood pH

  4 hours after intervention initiation

• blood bicarbonate level

  Within 3 hrs of arrival

• blood bicarbonate level

  4 hours after intervention initiation

Other Outcomes (3)

• Length of PICU Stay

  1-2 days

• Length of Hospital Stay

  1-5 days

• Hypoglycemic events

  length of hospital stay, an expected average of 3 days

Study Arms (2)

Control Group

PLACEBO COMPARATOR

The control group will receive all traditional methods of treatment for DKA including iv insulin, correction of fluid loss, and electrolyte correction, including a placebo subcutaneous injection.

Drug: IV insulin; Other: Electrolyte Correction; Other: Correction of Fluid Loss

Treatment Group

EXPERIMENTAL

The study group will receive the same treatment including iv insulin, correction of fluid loss, and electrolyte correction, but will be supplemented with a subcutaneous glargine injection.

Drug: Glargine; Drug: IV insulin; Other: Electrolyte Correction; Other: Correction of Fluid Loss

Interventions

Glargine DRUG

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.

Also known as: Lantus

Treatment Group

IV insulin DRUG

The intravenous infusion of insulin at a weight-based fixed rate until ketosis has subsided.

Control Group; Treatment Group

Electrolyte Correction OTHER

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.

Control Group; Treatment Group

Correction of Fluid Loss OTHER

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

Control Group; Treatment Group

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patients who received glargine within the last 24 hours
• Patients with sepsis

Sponsors & Collaborators

• Chattanooga-Hamilton County Hospital Authority: lead

Study Sites (1)

Children's @ Erlanger

Chattanooga, Tennessee, 37403, United States

Location

Related Publications (6)

• 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.)

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 24840321 BACKGROUND

• 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.

  PMID: 17508198 BACKGROUND

• 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.

  PMID: 22685233 BACKGROUND

• 6Lexicomp online

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetic Ketoacidosis

Interventions

Insulin Glargine; Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Ketosis; Acidosis; Acid-Base Imbalance; Diabetes Complications

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Proinsulin

Study Officials

• Rita Shridharani, MD

  UTCOMC/ Children's at Erlanger

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Shridharani

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 14, 2015
• Study Start: November 1, 2015
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: September 23, 2020

Record last verified: 2020-09

Locations

US (1)