Effectiveness of Subcutaneous Glargine On The Time To Closure of The Anion Gap in Patients Presenting to the Emergency Department With Diabetic Keto-acidosis

NCT02006342 | Completed Results

• 1 other identifier: HSC-MS-12-0535
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

To determine if co-administration of subcutaneous (SQ)Insulin glargine in combination with intravenous (IV) insulin decreases the time to resolution of ketoacidosis and requirement for ICU admission compared to IV insulin with delayed administration of SQ glargine for the treatment of diabetic ketoacidosis (DKA).

Conditions

Diabetic Ketoacidosis

Keywords

Diabetes Mellitus; Diabetic Ketoacidosis; Insulin Glargine; Anion gap; Metabolic acidosis

Outcome Measures

Primary Outcomes (1)

• Time to Anion Gap Closure

  Anion Gap is a measure of acidosis that results from decompensated Diabetes Mellitus. Acidosis is the result of the body being unable to utilize glucose for energy production and instead uses fatty acid metabolism resulting in ketone formation. Anion Gap is a surrogate measure for the level of ketones resulting in the excess acid production. Results reported are adjusted for initial anion gap, etiology of diabetic ketoacidosis, and comorbidities.

  Participants monitored from hospital admission to discharge, an average of 4 days

Secondary Outcomes (4)

• Number of Participants Admitted to the ICU

  Participants followed for the duration of the Emergency Department stay, an expected average of 12 hours

• Intensive Care Unit Length of Stay

  Participants monitored from hospital admission to discharge, an average of 4 days

• Hospital Length of Stay

  Participants monitored from hospital admission to discharge, an average of 4 days

• Number of Participants Who Developed Hypoglycemia

  Participants monitored during the 24 hours after anion gap closure

Study Arms (2)

Insulin Glargine plus Regular Insulin

EXPERIMENTAL

Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.

Drug: Insulin Glargine; Drug: Regular Insulin

Control - Regular Insulin

ACTIVE COMPARATOR

Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.

Drug: Regular Insulin

Interventions

Insulin Glargine DRUG

Also known as: Lantus Insulin

Insulin Glargine plus Regular Insulin

Regular Insulin DRUG

Control - Regular Insulin; Insulin Glargine plus Regular Insulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Blood Glucose \>200
• potential of hydrogen (pH) \< 7.3
• Bicarbonate \< 18
• Ketonemia or Ketonuria
• Anion Gap \> or = 16

You may not qualify if:

• Age \< 18 years
• Pregnant
• End state renal disease (ESRD)
• Prisoners
• Patients in shock or requiring emergency surgery
• Those unwilling to consent for the trial
• Allergic to Insulin Glargine

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (2)

Lyndon B Johnson Hospital

Houston, Texas, 77026, United States

Location

Memorial Herman Hospital-Texas Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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

• Doshi P, Potter AJ, De Los Santos D, Banuelos R, Darger BF, Chathampally Y. Prospective randomized trial of insulin glargine in acute management of diabetic ketoacidosis in the emergency department: a pilot study. Acad Emerg Med. 2015 Jun;22(6):657-62. doi: 10.1111/acem.12673. Epub 2015 May 25.

  PMID: 26013711 RESULT

MeSH Terms

Conditions

Diabetic Ketoacidosis; Diabetes Mellitus; Acidosis

Interventions

Insulin Glargine; Insulin

Condition Hierarchy (Ancestors)

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

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

Limitations and Caveats

The study had a limited sample size; therefore, the results cannot definitively answer the research question. Also, because a convenience sample was used, there might be selection bias.

Results Point of Contact

• Title: Dr. Pratik B. Doshi
• Organization: The University of Texas Health Science Center at Houston

Pratik.B.Doshi@uth.tmc.edu

713-608-6537

Study Officials

• Pratik B Doshi, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 20, 2013
• First Posted: December 10, 2013
• Study Start: November 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 16, 2017
• Results First Posted: May 16, 2017

Record last verified: 2017-04

Locations

US (2)