Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management

Type 2 Diabetes Clinical Trial

Official title:

Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04567225
• Other study ID #: 20-903
• Status: Terminated
• Phase: Phase 4
• Start date: October 1, 2020
• Est. completion date: August 27, 2021

Study information

• Verified date: August 2022
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management

Description:

The transition from IV Insulin Infusion (IVII) to Subcutaneous Long-acting insulin injections in Diabetic Ketoacidosis (DKA) management frequently results in rebound hyperglycemia, particularly if there are high insulin requirements that can adversely affect the DKA recovery, increase Length Of Stay (LOS), morbidity, and mortality. Investigators propose a prospective, open-label, intervention, non-randomized, controlled study to test the hypothesis that an insulin glargine dose of 0.4 Units/kg early administered (within four hours) of IVII initiation in DKA management in adult would be effective and safe in shortening the time to anion gap closure comparing to the standard practice.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: August 27, 2021
• Est. primary completion date: August 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years old
• Meet DKA definition (BG = 250 mg/dl, Anion Gap > 12 mEq/L, and positive Ketones in serum or urine)
• Having the capacity to sign Informed consent

Exclusion Criteria:

• IV insulin infusion was initiated for more than 4 hours.
• Persistent hypotension (SBP<80 mmHg despite receiving 1000cc normal saline).
• Require Vasopressor
• Acute Coronary Syndrome
• Pregnant
• End-stage renal disease
• Unwilling to consent to participate in the trial
• Currently under police custody
• Transferred from another hospital
• Require emergent surgery

Related Conditions & MeSH terms

• Acidosis
• Diabetes Mellitus
• Diabetic Ketoacidosis
• Ketosis
• Type 1 Diabetes
• Type 2 Diabetes

Intervention

Drug:
• Early Glargine
A dose of insulin glargine, 0.4 unit/kg, will be given within 4 hours from initiating the IV Insulin Infusion
• Late Glargine
A historical retrospective control group for the adult patients admitted to the same ICU with a diagnosis of DKA and received insulin glargine after anion gap closure.

Other:
• IV insulin infusion
Continuous weight based IV insulin infusion as per Cleveland Clinic DKA Protocol
• IV fluid and electrolytes replacement
The IV fluid and electrolytes replacement will be left to the treating physician's discretion. IV fluid to contain dextrose to keep Target Blood Glucose 150 - 200 mg/dl during the DKA management and 140 - 180 mg/dl after DKA resolution.

Locations

Country	Name	City	State
United States	Cleveland Clinic Fairview Hospital	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & Publications (8)

Bunn S, Halm M. Long-Acting Insulin on the Road to Recovery With Diabetic Ketoacidosis. Am J Crit Care. 2016 May;25(3):277-80. doi: 10.4037/ajcc2016681. Review. — View Citation

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. — View Citation

Houshyar J, Bahrami A, Aliasgarzadeh A. Effectiveness of Insulin Glargine on Recovery of Patients with Diabetic Ketoacidosis: A Randomized Controlled Trial. J Clin Diagn Res. 2015 May;9(5):OC01-5. doi: 10.7860/JCDR/2015/12005.5883. Epub 2015 May 1. — View 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. — View Citation

Kitabchi AE, Umpierrez GE, Miles JM, Fisher JN. Hyperglycemic crises in adult patients with diabetes. Diabetes Care. 2009 Jul;32(7):1335-43. doi: 10.2337/dc09-9032. Review. — View Citation

Realsen J, Goettle H, Chase HP. Morbidity and mortality of diabetic ketoacidosis with and without insulin pump care. Diabetes Technol Ther. 2012 Dec;14(12):1149-54. doi: 10.1089/dia.2012.0161. Epub 2012 Sep 25. Review. — View Citation

Savage MW, Dhatariya KK, Kilvert A, Rayman G, Rees JA, Courtney CH, Hilton L, Dyer PH, Hamersley MS; Joint British Diabetes Societies. Joint British Diabetes Societies guideline for the management of diabetic ketoacidosis. Diabet Med. 2011 May;28(5):508-15. doi: 10.1111/j.1464-5491.2011.03246.x. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Anion Gap Closure	Measured in hours from starting insulin infusion till anion gap = 12 milliequivalent/Liter (mEq/L)	Participants monitored from hospital admission to discharge, an average of 5 days
Secondary	Hospital Length of Stay	The time, in days, from the patient admission to the hospital till discharge	Participants monitored from hospital admission to discharge, an average of 5 days
Secondary	ICU Length of Stay	The time, in hours, from the patient admission to the ICU till transfer to regular nursing floor	Participants monitored from hospital admission to discharge, an average of 5 days
Secondary	Total IV Insulin Infusion Dose	the total amount of insulin infusion, by International Unit, has been received by the patient during the DKA treatment	Participants monitored from hospital admission to discharge, an average of 5 days
Secondary	Incidence of Transitional Failure	Defined as the recurrence of DKA (BG = 250 mg/dl, Anion Gap > 12 milliequivalent/Liter (mEq/L), and positive Ketones in serum or urine) after initial IV insulin infusion (IVII) discontinuation within 24 hours and requiring re-initiating the IVII	up to 24 hours after IVII discontinuation
Secondary	Incidence of Hyperglycemia	Incidence of hyperglycemia (> 180 mg/dL) after IVII discontinuation	up to 24 hours after initial Insulin Glargine dose
Secondary	Incidence of Hypoglycemia	Incidence of hypoglycemia (defined as = 70 mg/dL, <54 mg/dL, <40 mg/dl) after IVII discontinuation	up to 24 hours after initial Insulin Glargine dose