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Stopped after internal review
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Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Glargine | Experimental | 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. |
|
| Standard practice (Late Glargine) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Glargine | Drug | A dose of insulin glargine, 0.4 unit/kg, will be given within 4 hours from initiating the IV Insulin Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| ICU Length of Stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammed Al jaghbeer, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Fairview Hospital | Cleveland | Ohio | 44111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23009106 | Background | 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. | |
| 19564476 | Background | 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. |
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Individual subject results will not be shared with those involved in the prospective arm
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The study was closed due to lack of proper resource availability. Since study could not be completed as planned, no analysis was completed. This included no enrollment into the chart review arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Study withdrawn. The study was closed due to lack of proper resource availability. Since study could not be completed as planned, no analysis was completed.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Anion Gap Closure | Measured in hours from starting insulin infusion till anion gap ≤ 12 milliequivalent/Liter (mEq/L) | Study withdrawn. The study was closed due to lack of proper resource availability. Since study could not be completed as planned, no data was collected for analysis. | Posted | Participants monitored from hospital admission to discharge, an average of 5 days |
|
Consent through date of discharge (an average of 5 days)
No patients were enrolled in the Standard Practice (Late Glargine) arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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The study was closed due to lack of proper resource availability. Since study could not be completed as planned, no analysis was completed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mohammed Al-Jaghbeer | The Cleveland Clinic Foundation | 216-476-7983 | ALJAGHM@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 22, 2021 | Jun 30, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016883 | Diabetic Ketoacidosis |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D007662 | Ketosis |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| D005440 | Fluid Therapy |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Late Glargine | Drug | 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 | Other | Continuous weight based IV insulin infusion as per Cleveland Clinic DKA Protocol |
|
| IV fluid and electrolytes replacement | Other | 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. |
|
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 |
| 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 |
| 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 |
| Incidence of Hyperglycemia | Incidence of hyperglycemia (> 180 mg/dL) after IVII discontinuation | up to 24 hours after initial Insulin Glargine dose |
| 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 |
| 27134235 | Background | 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. |
| 22685233 | 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. |
| 21255074 | Background | 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. |
| 26013711 | 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. |
| 26155506 | Background | 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. |
| 17508198 | 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. |
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. 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. |
|
| Secondary | Hospital Length of Stay | The time, in days, from the patient admission to the hospital till discharge | Study withdrawn. The study was closed due to lack of proper resource availability. Since study could not be completed as planned, no data was collected for analysis. | Posted | 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 | Study withdrawn. The study was closed due to lack of proper resource availability. Since study could not be completed as planned, no data was collected for analysis. | Posted | 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 | Study withdrawn. The study was closed due to lack of proper resource availability. Since study could not be completed as planned, no data was collected for analysis. | Posted | 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 | Study withdrawn. The study was closed due to lack of proper resource availability. Since study could not be completed as planned, no data was collected for analysis. | Posted | up to 24 hours after IVII discontinuation |
|
|
| Secondary | Incidence of Hyperglycemia | Incidence of hyperglycemia (> 180 mg/dL) after IVII discontinuation | Study withdrawn. The study was closed due to lack of proper resource availability. Since study could not be completed as planned, no data was collected for analysis. | Posted | 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 | Study withdrawn. The study was closed due to lack of proper resource availability. Since study could not be completed as planned, no data was collected for analysis. | Posted | up to 24 hours after initial Insulin Glargine dose |
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | 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. 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |