Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04567225
• Collaborator: (none)
• Enrollment: 39
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.8
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief Summary

Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management

Condition or Disease	Intervention/Treatment	Phase
Diabetic Ketoacidosis; Type 1 Diabetes; Type 2 Diabetes	Drug: Early Glargine; Drug: Late Glargine; Other: IV insulin infusion; Other: IV fluid and electrolytes replacement	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management
• Actual Study Start Date: Oct 1, 2020
• Actual Primary Completion Date: Aug 27, 2021
• Actual Study Completion Date: Aug 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Early Glargine; A dose of insulin glargine, 0.4 unit/kg, will be given within 4 hours from initiating the IV Insulin Infusion; Other Names: lantus ; Other: IV insulin infusion; Continuous weight based IV insulin infusion as per Cleveland Clinic DKA Protocol; Other: 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.
Active Comparator: 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.	Drug: 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 Names: lantus ; Other: IV insulin infusion; Continuous weight based IV insulin infusion as per Cleveland Clinic DKA Protocol; Other: 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.

Outcome Measures

Primary Outcome Measures

1. Time to Anion Gap Closure [Participants monitored from hospital admission to discharge, an average of 5 days]

   Measured in hours from starting insulin infusion till anion gap ≤ 12 milliequivalent/Liter (mEq/L)

Secondary Outcome Measures

1. Hospital Length of Stay [Participants monitored from hospital admission to discharge, an average of 5 days]

   The time, in days, from the patient admission to the hospital till discharge

2. ICU Length of Stay [Participants monitored from hospital admission to discharge, an average of 5 days]

   The time, in hours, from the patient admission to the ICU till transfer to regular nursing floor

3. Total IV Insulin Infusion Dose [Participants monitored from hospital admission to discharge, an average of 5 days]

   the total amount of insulin infusion, by International Unit, has been received by the patient during the DKA treatment

4. Incidence of Transitional Failure [up to 24 hours after IVII discontinuation]

   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

5. Incidence of Hyperglycemia [up to 24 hours after initial Insulin Glargine dose]

   Incidence of hyperglycemia (> 180 mg/dL) after IVII discontinuation

6. Incidence of Hypoglycemia [up to 24 hours after initial Insulin Glargine dose]

   Incidence of hypoglycemia (defined as ≤ 70 mg/dL, <54 mg/dL, <40 mg/dl) after IVII discontinuation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic Fairview Hospital	Cleveland	Ohio	United States	44111

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

• Principal Investigator: Mohammed Al jaghbeer, MD, The Cleveland Clinic

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 22, 2021

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Mohammed Al-Jaghbeer, Clinical Assistant professor and Principal Investigator, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT04567225
• Other Study ID Numbers: 20-903
• First Posted: Sep 28, 2020
• Last Update Posted: Aug 25, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Diabetes Mellitus; Ketosis; Acidosis; Diabetic Ketoacidosis; Insulin Glargine

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Early Glargine	Standard Practice (Late Glargine)
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	39	0
COMPLETED	0	0
NOT COMPLETED	39	0

Baseline Characteristics

Arm/Group Title	Early Glargine	Standard Practice (Late Glargine)	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	39	0	39
Age (Count of Participants)
<=18 years	0 0%	0 NaN	0 0%
Between 18 and 65 years	31 79.5%	0 NaN	31 79.5%
>=65 years	8 20.5%	0 NaN	8 20.5%
Sex: Female, Male (Count of Participants)
Female	20 51.3%	0 NaN	20 51.3%
Male	19 48.7%	0 NaN	19 48.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	10 25.6%	0 NaN	10 25.6%
Not Hispanic or Latino	29 74.4%	0 NaN	29 74.4%
Unknown or Not Reported	0 0%	0 NaN	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 NaN
Asian	0 0%	0 NaN
Native Hawaiian or Other Pacific Islander	0 0%	0 NaN
Black or African American	11 28.2%	11 Infinity
White	21 53.8%	21 Infinity
More than one race	0 0%	0 NaN
Unknown or Not Reported	7 17.9%	7 Infinity
Region of Enrollment (participants) [Number]
United States	39 100%	39 Infinity

Outcome Measures

1. Primary Outcome

Title	Time to Anion Gap Closure
Description	Measured in hours from starting insulin infusion till anion gap ≤ 12 milliequivalent/Liter (mEq/L)
Time Frame	Participants monitored from hospital admission to discharge, an average of 5 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Early Glargine	Standard Practice (Late Glargine)
Arm/Group Description	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.	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.
Measure Participants	0	0

2. Secondary Outcome

Title	Hospital Length of Stay
Description	The time, in days, from the patient admission to the hospital till discharge
Time Frame	Participants monitored from hospital admission to discharge, an average of 5 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Early Glargine	Standard Practice (Late Glargine)
Arm/Group Description	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.	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.
Measure Participants	0	0

3. Secondary Outcome

Title	ICU Length of Stay
Description	The time, in hours, from the patient admission to the ICU till transfer to regular nursing floor
Time Frame	Participants monitored from hospital admission to discharge, an average of 5 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Early Glargine	Standard Practice (Late Glargine)
Arm/Group Description	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.	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.
Measure Participants	0	0

4. Secondary Outcome

Title	Total IV Insulin Infusion Dose
Description	the total amount of insulin infusion, by International Unit, has been received by the patient during the DKA treatment
Time Frame	Participants monitored from hospital admission to discharge, an average of 5 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Early Glargine	Standard Practice (Late Glargine)
Arm/Group Description	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.	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.
Measure Participants	0	0

5. Secondary Outcome

Title	Incidence of Transitional Failure
Description	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
Time Frame	up to 24 hours after IVII discontinuation

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Early Glargine	Standard Practice (Late Glargine)
Arm/Group Description	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.	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.
Measure Participants	0	0

6. Secondary Outcome

Title	Incidence of Hyperglycemia
Description	Incidence of hyperglycemia (> 180 mg/dL) after IVII discontinuation
Time Frame	up to 24 hours after initial Insulin Glargine dose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Early Glargine	Standard Practice (Late Glargine)
Arm/Group Description	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.	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.
Measure Participants	0	0

7. Secondary Outcome

Title	Incidence of Hypoglycemia
Description	Incidence of hypoglycemia (defined as ≤ 70 mg/dL, <54 mg/dL, <40 mg/dl) after IVII discontinuation
Time Frame	up to 24 hours after initial Insulin Glargine dose

Outcome Measure Data

Analysis Population Description

The study was closed due to lack of proper resource availability. Since study could not be completed as planned, no analysis was completed.

Arm/Group Title	Early Glargine	Standard Practice (Late Glargine)
Arm/Group Description	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.	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.
Measure Participants	0	0

Adverse Events

Time Frame	Consent through date of discharge (an average of 5 days)
Adverse Event Reporting Description	No patients were enrolled in the Standard Practice (Late Glargine) arm.
Arm/Group Title	Early Glargine		Standard Practice (Late Glargine)
Arm/Group Description	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.		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.
All Cause Mortality
	Early Glargine		Standard Practice (Late Glargine)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/0 (NaN)
Serious Adverse Events
	Early Glargine		Standard Practice (Late Glargine)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Early Glargine		Standard Practice (Late Glargine)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/0 (NaN)

Limitations/Caveats

The study was closed due to lack of proper resource availability. Since study could not be completed as planned, no analysis was completed.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.