Clinical trial NCT04567225: Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management
Official title: Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetic Ketoacidosis
Type 1 Diabetes
Type 2 Diabetes
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to Anion Gap Closure
timeFrame: Participants monitored from hospital admission to discharge, an average of 5 days
Secondary outcomes:
measure: Hospital Length of Stay
timeFrame: Participants monitored from hospital admission to discharge, an average of 5 days
measure: ICU Length of Stay
timeFrame: Participants monitored from hospital admission to discharge, an average of 5 days
measure: Total IV Insulin Infusion Dose
timeFrame: Participants monitored from hospital admission to discharge, an average of 5 days
measure: Incidence of Transitional Failure
timeFrame: up to 24 hours after IVII discontinuation
measure: Incidence of Hyperglycemia
timeFrame: up to 24 hours after initial Insulin Glargine dose
measure: Incidence of Hypoglycemia
timeFrame: up to 24 hours after initial Insulin Glargine dose
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Fairview Hospital
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Mohammed Al jaghbeer, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. No abstract available.
citation: 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. No abstract available.
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: 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.
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.
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.
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.