Eligibility Module

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: 2025-12-25 @ 2:29 AM
Ignite Modification Date: 2025-12-25 @ 2:29 AM
NCT ID: NCT01401634
Eligibility Criteria: Inclusion Criteria: * Any patient, above the age of 18 years old, presenting to Emergency Department triage with a fingerstick glucose between 250 and 500 mg/dL Exclusion Criteria: * Patients with evidence of DKA (hyperglycemia with ketonuria and abnormal pH or bicarbonate on venous blood gas), HHS, or other critical illnesses requiring immediate medical attention (as determined by ED triage nurses), * end-stage renal disease requiring dialysis through an arterio-venous shunt or fistula, * abnormal mental status (GCS \< 15), * unstable vital signs including pulse \> 100, SBP \< 100, respiratory rate\>20, (or any combination of vital signs not meeting these cutoffs but deemed worrisome by the triage nurse) or unable to tolerate oral intake/actively vomiting. * Patients who receive IV fluids prior to or during the study period. * Patients unable to communicate in English or Spanish. * Jail patients will also be excluded.
Healthy Volunteers: False
Sex: ALL
Minimum Age: 18 Years
Study: NCT01401634
Study Brief:
Protocol Section: NCT01401634