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Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management

Primary Purpose

Diabetic Ketoacidosis, Type 1 Diabetes, Type 2 Diabetes

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Early Glargine
Late Glargine
IV insulin infusion
IV fluid and electrolytes replacement
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Ketoacidosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic Fairview Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early Glargine

Standard practice (Late Glargine)

Arm 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.

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.

Outcomes

Primary Outcome Measures

Time to Anion Gap Closure
Measured in hours from starting insulin infusion till anion gap ≤ 12 milliequivalent/Liter (mEq/L)

Secondary Outcome Measures

Hospital Length of Stay
The time, in days, from the patient admission to the hospital till discharge
ICU Length of Stay
The time, in hours, from the patient admission to the ICU till transfer to regular nursing floor
Total IV Insulin Infusion Dose
the total amount of insulin infusion, by International Unit, has been received by the patient during the DKA treatment
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
Incidence of Hyperglycemia
Incidence of hyperglycemia (> 180 mg/dL) after IVII discontinuation
Incidence of Hypoglycemia
Incidence of hypoglycemia (defined as ≤ 70 mg/dL, <54 mg/dL, <40 mg/dl) after IVII discontinuation

Full Information

First Posted
September 23, 2020
Last Updated
August 24, 2022
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04567225
Brief Title
Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management
Official Title
Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Stopped after internal review
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
August 27, 2021 (Actual)
Study Completion Date
August 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Ketoacidosis, Type 1 Diabetes, Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Glargine
Arm Type
Experimental
Arm 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.
Arm Title
Standard practice (Late Glargine)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Early Glargine
Other Intervention Name(s)
lantus
Intervention Description
A dose of insulin glargine, 0.4 unit/kg, will be given within 4 hours from initiating the IV Insulin Infusion
Intervention Type
Drug
Intervention Name(s)
Late Glargine
Other Intervention Name(s)
lantus
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
IV insulin infusion
Intervention Description
Continuous weight based IV insulin infusion as per Cleveland Clinic DKA Protocol
Intervention Type
Other
Intervention Name(s)
IV fluid and electrolytes replacement
Intervention Description
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.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
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
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Al jaghbeer, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Fairview Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual subject results will not be shared with those involved in the prospective arm
Citations:
PubMed Identifier
23009106
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.
Results Reference
background
PubMed Identifier
19564476
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.
Results Reference
background
PubMed Identifier
27134235
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.
Results Reference
background
PubMed Identifier
22685233
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.
Results Reference
background
PubMed Identifier
21255074
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.
Results Reference
background
PubMed Identifier
26013711
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.
Results Reference
background
PubMed Identifier
26155506
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.
Results Reference
background
PubMed Identifier
17508198
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.
Results Reference
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Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management

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