Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management
NCT ID: NCT04567225
Last Updated: 2022-09-21
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
39 participants
INTERVENTIONAL
2020-10-01
2021-08-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Early Glargine
All consecutive adult patients getting admitted to Medical ICU and meet the inclusion criteria and accepted to receive insulin glargine early as per the protocol. They will receive insulin glargine 0.4 unit/kg within 4 hours from initiating the IV Insulin Infusion, as per the Cleveland Clinic DKA protocol.
Early Glargine
A dose of insulin glargine, 0.4 unit/kg, will be given within 4 hours from initiating the IV Insulin Infusion
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.
Standard practice (Late Glargine)
Retrospective, prespecified and matched sample of consecutive adults who admitted to the same Medical ICU with a diagnosis of DKA in the period between January 1st 2019 till the Institutional Review Board (IRB) approval date and didn't receive basal insulin before Anion Gap closure.
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Mohammed Al-Jaghbeer
Clinical Assistant professor and Principal Investigator
Principal Investigators
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Mohammed Al jaghbeer, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic Fairview Hospital
Cleveland, Ohio, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20-903
Identifier Type: -
Identifier Source: org_study_id
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