Status:
TERMINATED
Early Administration of Insulin Glargine in Patients With Diabetic Ketoacidosis
Lead Sponsor:
HealthPartners Institute
Conditions:
DKA
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Diabetic ketoacidosis (DKA) is a medical emergency that is associated with significant morbidity and mortality for both patients with type I and type II diabetes. By correcting hyperglycemia and inhib...
Detailed Description
In 2014, there were 168,000 hospitalizations for DKA, and the average length of stay was 3.4 days in 2009. The estimated annual direct medical expense and indirect cost is 2.4 billion dollars per year...
Eligibility Criteria
Inclusion
- Presented to Regions Hospital ED for chief complaint of DKA, nausea, vomiting, abdominal pain, hyperglycemia, or similar
- Meets all below diagnostic criteria for DKA per the American Diabetes Association:
- Arterial or venous pH \</= 7.3
- Serum Bicarbonate \</= 18 mEq/L
- Ketonuria or ketonemia
- Anion Gap \> 10
- Blood sugar \> 250 mg/dL
- Receiving IV insulin infusion
- It is feasible to provide insulin glargine within 2 hours (+/- 30 minutes) of IV infusion start
- Will be admitted to the ICU for DKA, or already admitted to the ICU for DKA
- Ability to provide informed consent
Exclusion
- Age \< 18
- End stage renal disease or hepatic disease
- Hypotension requiring IV vasopressors or inotropes at any point during admission (i.e. norepinephrine, dobutamine, vasopressin, etc.)
- Need for emergent surgery
- Pregnant patients
- Prisoners
- Indication for insulin therapy other than DKA (hypertriglyceridemia, beta-blocker overdose, hyperglycemia without DKA)
- Patients receiving prior to admission insulin pump therapy
- Patients receiving prior to admission combination insulin products (i.e. Novolin® 70/30, Novolog® 70/30, Humalog® 75/25, etc.)
- Did not consent to study
Key Trial Info
Start Date :
May 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2023
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06007508
Start Date
May 31 2022
End Date
February 28 2023
Last Update
June 18 2024
Active Locations (1)
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1
Regions Hospital
Saint Paul, Minnesota, United States, 55101