Clinical trial NCT02930044: Early Subcutaneous Insulin Glargine Plus Standard of Care for Treatment of Diabetic Ketoacidosis
Official title: Prospective Comparison of Early Subcutaneous Insulin Glargine Plus Standard of Care Versus Standard of Care for Treatment of Diabetic Ketoacidosis in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Ketoacidosis
Keywords: Emergency department
Insulin
Adult
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2016-10-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether adult DKA patients who present to the emergency department treated with early subcutaneous long acting insulin versus standard care receive a shorter total duration of intravenous (IV) insulin infusion.

Detailed description: Specific Aims: To evaluate the impact of early administration of subcutaneous glargine versus standard care on time of insulin infusion in DKA patients and other secondary outcomes listed in this application.

Methods: DKA patients enrolled in this study will receive the long acting glargine dose (0.3 units/kg with a maximum dose of 30 units) within two hours after initiation the IV insulin infusion. Besides timing of the glargine dose, no other changes in standard patient care will occur in those patients enrolled in this study, the same labs will be collected and the insulin infusion will be titrated using the same hospital protocol algorithm.

Patients enrolled in the prospective arm will be compared with the retrospective control group, which received standard insulin therapy (subcutaneous insulin glargine administered at least 2 to 3 hours prior to termination of the insulin infusion). There will be 18 patients in this group selected in reverse chronological order from our pre-specified date range of 8/1/2014 to 7/31/2016.

Eligibility criteria: Inclusion Criteria:

* Bicarbonate \<18 mg/dL
* Anion gap \>16
* Blood glucose \>250 mg/dL
* Ketonemia or ketonuria

Exclusion Criteria:

* Pregnant women
* Refused consent
* Patient left ED against medical advice

Primary outcomes:
measure: Duration of intravenous insulin infusion
timeFrame: up to 10 months
Secondary outcomes:
measure: Time to resolution of high serum glucose (hyperglycemia)
timeFrame: up to 10 months
measure: Time to closure of anion gap
timeFrame: up to 10 months
measure: Time to correction of bicarbonate
timeFrame: up to 10 months
measure: Time to correction of serum pH
timeFrame: up to 10 months
measure: Total duration of hospital stay
timeFrame: up to 10 months
measure: Return of DKA within 24 hours
timeFrame: up to 10 months
measure: Incidence of low serum glucose (hypoglycemia) within 24 hours
timeFrame: up to 10 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
affiliation: Director of Undergraduate Medical Education
name: George C Willis, MD
role: PRINCIPAL_INVESTIGATOR
References: