Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT06007508
Eligibility Criteria:
Inclusion Criteria:
1. Presented to Regions Hospital ED for chief complaint of DKA, nausea, vomiting, abdominal pain, hyperglycemia, or similar
2. 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
3. Receiving IV insulin infusion
4. It is feasible to provide insulin glargine within 2 hours (+/- 30 minutes) of IV infusion start
5. Will be admitted to the ICU for DKA, or already admitted to the ICU for DKA
6. Ability to provide informed consent
Exclusion Criteria:
1. Age \< 18
2. End stage renal disease or hepatic disease
3. Hypotension requiring IV vasopressors or inotropes at any point during admission (i.e. norepinephrine, dobutamine, vasopressin, etc.)
4. Need for emergent surgery
5. Pregnant patients
6. Prisoners
7. Indication for insulin therapy other than DKA (hypertriglyceridemia, beta-blocker overdose, hyperglycemia without DKA)
8. Patients receiving prior to admission insulin pump therapy
9. Patients receiving prior to admission combination insulin products (i.e. Novolin® 70/30, Novolog® 70/30, Humalog® 75/25, etc.)
10. Did not consent to study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06007508
Study Brief:
Protocol Section:
NCT06007508