Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management

Phase 4

Terminated

Conditions: Diabetic Ketoacidosis
Type 1 Diabetes
Type 2 Diabetes

Interventions: Drug: Early Glargine
Drug: Late Glargine
Other: IV insulin infusion
Other: IV fluid and electrolytes replacement

Registration Number: NCT04567225

Lead Sponsor: The Cleveland Clinic

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 39

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Early Glargine	IV insulin infusion	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)	IV insulin infusion	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.
Early Glargine	IV fluid and electrolytes replacement	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	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.
Standard practice (Late Glargine)	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.
Standard practice (Late Glargine)	IV fluid and electrolytes replacement	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
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
Incidence of Hyperglycemia	up to 24 hours after initial Insulin Glargine dose	Incidence of hyperglycemia (\> 180 mg/dL) after IVII discontinuation
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