Early Subcutaneous Insulin Glargine Plus Standard of Care for Treatment of Diabetic Ketoacidosis

University of Maryland Baltimore (UMB)

Status: Completed

Conditions: Diabetic Ketoacidosis

Treatments: Other: IV insulin infusion; Drug: IV fluid repletion; Other: Early administration of subcutaneous insulin glargine dose

Study type: Interventional

Funder types: Other

Identifiers

NCT02930044

HP-00070969

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups, including a placebo group

Early glargine dose

Experimental group

Description:

Subcutaneous insulin glargine will be administered within two hours of starting the IV insulin infusion.

Treatment:

Drug: IV fluid repletion

Other: Early administration of subcutaneous insulin glargine dose

Other: IV insulin infusion

Standard therapy

Placebo Comparator group

Description:

Retrospective arm that received standard insulin therapy for treatment of DKA

Treatment:

Drug: IV fluid repletion

Other: IV insulin infusion