Effectiveness of Subcutaneous Glargine On The Time To Closure of The Anion Gap in Patients Presenting to the Emergency Department With Diabetic Keto-acidosis: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Time to Anion Gap Closure
Study Overview
Brief Summary
To determine if co-administration of subcutaneous (SQ)Insulin glargine in combination with intravenous (IV) insulin decreases the time to resolution of ketoacidosis and requirement for ICU admission compared to IV insulin with delayed administration of SQ glargine for the treatment of diabetic ketoacidosis (DKA).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age >18 years
- •Blood Glucose >200
- •potential of hydrogen (pH) < 7.3
- •Bicarbonate < 18
- •Ketonemia or Ketonuria
- •Anion Gap > or = 16
Exclusion Criteria
- •Age < 18 years
- •End state renal disease (ESRD)
- •Prisoners
- •Patients in shock or requiring emergency surgery
- •Those unwilling to consent for the trial
- •Allergic to Insulin Glargine
Arms & Interventions
Insulin Glargine plus Regular Insulin
Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.
Intervention: Insulin Glargine (Drug)
Insulin Glargine plus Regular Insulin
Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.
Intervention: Regular Insulin (Drug)
Control - Regular Insulin
Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.
Intervention: Regular Insulin (Drug)
Outcomes
Primary Outcomes
Time to Anion Gap Closure
Time Frame: Participants monitored from hospital admission to discharge, an average of 4 days
Anion Gap is a measure of acidosis that results from decompensated Diabetes Mellitus. Acidosis is the result of the body being unable to utilize glucose for energy production and instead uses fatty acid metabolism resulting in ketone formation. Anion Gap is a surrogate measure for the level of ketones resulting in the excess acid production. Results reported are adjusted for initial anion gap, etiology of diabetic ketoacidosis, and comorbidities.
Secondary Outcomes
- Number of Participants Admitted to the ICU(Participants followed for the duration of the Emergency Department stay, an expected average of 12 hours)
- Intensive Care Unit Length of Stay(Participants monitored from hospital admission to discharge, an average of 4 days)
- Hospital Length of Stay(Participants monitored from hospital admission to discharge, an average of 4 days)
- Number of Participants Who Developed Hypoglycemia(Participants monitored during the 24 hours after anion gap closure)
Investigators
Pratik B Doshi
Assistant Professor
The University of Texas Health Science Center, Houston