Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management

August 24, 2022 updated by: Mohammed Al-Jaghbeer, The Cleveland Clinic
Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44111
        • Cleveland Clinic Fairview Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Anion Gap Closure
Time Frame: 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)
Participants monitored from hospital admission to discharge, an average of 5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Length of Stay
Time Frame: 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
Participants monitored from hospital admission to discharge, an average of 5 days
ICU Length of Stay
Time Frame: 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
Participants monitored from hospital admission to discharge, an average of 5 days
Total IV Insulin Infusion Dose
Time Frame: 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
Participants monitored from hospital admission to discharge, an average of 5 days
Incidence of Transitional Failure
Time Frame: 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
up to 24 hours after IVII discontinuation
Incidence of Hyperglycemia
Time Frame: up to 24 hours after initial Insulin Glargine dose
Incidence of hyperglycemia (> 180 mg/dL) after IVII discontinuation
up to 24 hours after initial Insulin Glargine dose
Incidence of Hypoglycemia
Time Frame: 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
up to 24 hours after initial Insulin Glargine dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

August 27, 2021

Study Completion (Actual)

August 27, 2021

Study Registration Dates

First Submitted

September 23, 2020

First Submitted That Met QC Criteria

September 23, 2020

First Posted (Actual)

September 28, 2020

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-903

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual subject results will not be shared with those involved in the prospective arm

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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