NCT04567225

Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Ketoacidosis
• Type 1 Diabetes
• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Early Glargine	A dose of insulin glargine, 0.4 unit/kg, will be given within 4 hours from initiating the IV Insulin Infusion
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	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.

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-08-27
• Completion: 2021-08-27
• First posted: 2020-09-28
• Last updated: 2022-09-21
• Results posted: 2022-08-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study