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Completed

NCT Number: NCT02930044

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

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.

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Key information

Conditions

Diabetic Ketoacidosis Acid-Base Imbalance Acidosis Diabetes Complications Diabetes Mellitus Disease Attributes Emergencies Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Ketosis Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland Medical Center

Baltimore, Maryland, 21217, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early administration of subcutaneous insulin glargine dose

Other

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.

IV insulin infusion

Other

All patients will receive the standard of care which is a protocol based continuous insulin infusion

IV fluid repletion

Drug

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 outcomes

  1. Duration of intravenous insulin infusion

    Time frame: up to 10 months

    Measured in minutes from starting insulin infusion

Secondary outcomes

  1. Time to resolution of high serum glucose (hyperglycemia)

    Time frame: up to 10 months

    Measured in minutes from starting insulin infusion

  2. Time to closure of anion gap

    Time frame: up to 10 months

    Measured in minutes from starting insulin infusion

  3. Time to correction of bicarbonate

    Time frame: up to 10 months

    Measured by serum bicarbonate

  4. Time to correction of serum pH

    Time frame: up to 10 months

    Measured by pH on venous blood gas

  5. Total duration of hospital stay

    Time frame: up to 10 months

    Measured in days

  6. Return of DKA within 24 hours

    Time frame: up to 10 months

    Indicated by presence of diagnostic criteria within 24 hours of starting insulin infusion

  7. Incidence of low serum glucose (hypoglycemia) within 24 hours

    Time frame: up to 10 months

    Measure by serum glucose.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Oct 11, 2016
Registry last updated
Apr 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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