Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management

NeuroTherapia, Inc.

Status and phase: Terminated; Phase 4

Conditions: Type 1 Diabetes; Diabetic Ketoacidosis; Type 2 Diabetes

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04567225

20-903

Details and patient eligibility

About

Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

39 participants in 2 patient groups

Early Glargine

Experimental 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.

Treatment:

Drug: Early Glargine

Other: IV insulin infusion

Other: IV fluid and electrolytes replacement

Standard practice (Late Glargine)

Active Comparator group

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.

Treatment:

Drug: Late Glargine

Other: IV insulin infusion

Other: IV fluid and electrolytes replacement