Effectiveness of Subcutaneous Glargine On The Time To Closure of The Anion Gap in Patients Presenting to the Emergency Department With Diabetic Keto-acidosis (GT-COG)
Status
Completed
Conditions
Diabetic Ketoacidosis
Treatments
Drug: Regular Insulin
Drug: Insulin Glargine
Details and patient eligibility
About
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).
Enrollment
40 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
- Pregnant
- End state renal disease (ESRD)
- Prisoners
- Patients in shock or requiring emergency surgery
- Those unwilling to consent for the trial
- Allergic to Insulin Glargine
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Single Group Assignment
Masking
Single Blind
40 participants in 2 patient groups
Insulin Glargine plus Regular Insulin
Experimental group
Description:
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.
Treatment:
Drug: Regular Insulin
Drug: Insulin Glargine
Control - Regular Insulin
Active Comparator group
Description:
Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.
Treatment:
Drug: Regular Insulin
Trial contacts and locations
2
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2024 Veeva Systems