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

Not Applicable

Completed

• Conditions: Diabetic Ketoacidosis
• Interventions: Other: Early administration of subcutaneous insulin glargine dose; Other: IV insulin infusion; Drug: IV fluid repletion

• Registration Number: NCT02930044
• Lead Sponsor: University of Maryland, Baltimore

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-09-14
• Study Start: 2016-10
• Study First Submitted QC: 2016-10-08
• Study First Posted: 2016-10-11
• Primary Completion: 2021-11-01
• Study Completion: 2021-11-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-19
• Last Update Posted: 2022-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early glargine dose	Early administration of subcutaneous insulin glargine dose	Subcutaneous insulin glargine will be administered within two hours of starting the IV insulin infusion.
Early glargine dose	IV insulin infusion	Subcutaneous insulin glargine will be administered within two hours of starting the IV insulin infusion.
Early glargine dose	IV fluid repletion	Subcutaneous insulin glargine will be administered within two hours of starting the IV insulin infusion.
Standard therapy	IV insulin infusion	Retrospective arm that received standard insulin therapy for treatment of DKA
Standard therapy	IV fluid repletion	Retrospective arm that received standard insulin therapy for treatment of DKA

Primary Outcome Measures

Name	Time	Method
Duration of intravenous insulin infusion	up to 10 months	Measured in minutes from starting insulin infusion

Secondary Outcome Measures

Name	Time	Method
Time to closure of anion gap	up to 10 months	Measured in minutes from starting insulin infusion
Time to resolution of high serum glucose (hyperglycemia)	up to 10 months	Measured in minutes from starting insulin infusion
Time to correction of bicarbonate	up to 10 months	Measured by serum bicarbonate
Time to correction of serum pH	up to 10 months	Measured by pH on venous blood gas
Total duration of hospital stay	up to 10 months	Measured in days
Return of DKA within 24 hours	up to 10 months	Indicated by presence of diagnostic criteria within 24 hours of starting insulin infusion
Incidence of low serum glucose (hypoglycemia) within 24 hours	up to 10 months	Measure by serum glucose.

Trial Locations

Locations (1)

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States