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

Primary Purpose

Diabetic Ketoacidosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early administration of subcutaneous insulin glargine dose
IV insulin infusion
IV fluid repletion
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Ketoacidosis focused on measuring Emergency department, Insulin, Adult

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Maryland Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Early glargine dose

Standard therapy

Arm Description

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

Retrospective arm that received standard insulin therapy for treatment of DKA

Outcomes

Primary Outcome Measures

Duration of intravenous insulin infusion
Measured in minutes from starting insulin infusion

Secondary Outcome Measures

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

Full Information

First Posted
September 14, 2016
Last Updated
March 19, 2022
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT02930044
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Ketoacidosis
Keywords
Emergency department, Insulin, Adult

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early glargine dose
Arm Type
Experimental
Arm Description
Subcutaneous insulin glargine will be administered within two hours of starting the IV insulin infusion.
Arm Title
Standard therapy
Arm Type
Placebo Comparator
Arm Description
Retrospective arm that received standard insulin therapy for treatment of DKA
Intervention Type
Other
Intervention Name(s)
Early administration of subcutaneous insulin glargine dose
Intervention Description
DKA patients in the prospective intervention arm will receive subcutaneous glargine within two hours of starting their intravenous insulin infusion. The dose of glargine is 0.3 units/kg with a maximum dose of 30 units.
Intervention Type
Other
Intervention Name(s)
IV insulin infusion
Intervention Description
All patients will receive the standard of care which is a protocol based continuous insulin infusion
Intervention Type
Drug
Intervention Name(s)
IV fluid repletion
Intervention Description
0.9% NaCl or Plasmalyte A will be initiated as a continuous infusion for volume repletion. Fluids will be switched to contain potassium if serum potassium is less than 3.3 mEq/L. Fluids will be switched to contain dextrose if the serum glucose is less than 250 mg/dL.
Primary Outcome Measure Information:
Title
Duration of intravenous insulin infusion
Description
Measured in minutes from starting insulin infusion
Time Frame
up to 10 months
Secondary Outcome Measure Information:
Title
Time to resolution of high serum glucose (hyperglycemia)
Description
Measured in minutes from starting insulin infusion
Time Frame
up to 10 months
Title
Time to closure of anion gap
Description
Measured in minutes from starting insulin infusion
Time Frame
up to 10 months
Title
Time to correction of bicarbonate
Description
Measured by serum bicarbonate
Time Frame
up to 10 months
Title
Time to correction of serum pH
Description
Measured by pH on venous blood gas
Time Frame
up to 10 months
Title
Total duration of hospital stay
Description
Measured in days
Time Frame
up to 10 months
Title
Return of DKA within 24 hours
Description
Indicated by presence of diagnostic criteria within 24 hours of starting insulin infusion
Time Frame
up to 10 months
Title
Incidence of low serum glucose (hypoglycemia) within 24 hours
Description
Measure by serum glucose.
Time Frame
up to 10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George C Willis, MD
Organizational Affiliation
Director of Undergraduate Medical Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21217
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual subject results will not be shared with those involved in the prospective arm.

Learn more about this trial

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

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