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Clinical Trial Details

Trial ID: L2214
Source ID: NCT04567225
Associated Drug: Early Glargine
Title: Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management
Acronym:
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04567225/results
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
Outcome Measures: Primary: Time to Anion Gap Closure, 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: Hospital Length of Stay, 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, 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, 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, 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, Incidence of hyperglycemia (\> 180 mg/dL) after IVII discontinuation, up to 24 hours after initial Insulin Glargine dose|Incidence of Hypoglycemia, 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
Sponsor/Collaborators: Sponsor: The Cleveland Clinic
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 39
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-10-01
Completion Date: 2021-08-27
Results First Posted: 2022-08-25
Last Update Posted: 2022-09-21
Locations: Cleveland Clinic Fairview Hospital, Cleveland, Ohio, 44111, United States
URL: https://clinicaltrials.gov/show/NCT04567225