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Trial record 5 of 34 for:    "Diabetic Ketoacidosis"

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

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ClinicalTrials.gov Identifier: NCT02930044
Recruitment Status : Recruiting
First Posted : October 11, 2016
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
George Willis, University of Maryland

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.

Condition or disease Intervention/treatment Phase
Diabetic Ketoacidosis Other: Early administration of subcutaneous insulin glargine dose Other: IV insulin infusion Drug: IV fluid repletion Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early glargine dose
Subcutaneous insulin glargine will be administered within two hours of starting the IV insulin infusion.
Other: Early administration of subcutaneous insulin glargine dose
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.

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

Drug: IV fluid repletion
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.

Placebo Comparator: Standard therapy
Retrospective arm that received standard insulin therapy for treatment of DKA
Other: IV insulin infusion
All patients will receive the standard of care which is a protocol based continuous insulin infusion

Drug: IV fluid repletion
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 Measures :
  1. Duration of intravenous insulin infusion [ Time Frame: up to 10 months ]
    Measured in minutes from starting insulin infusion


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02930044


Contacts
Contact: George C Willis, MD 410-328-8025 gwillis@em.umaryland.edu
Contact: Linda H Barstow, PharmD 410-328-4894 LindaBarstow@umm.edu

Locations
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21217
Contact: George C Willis, MD    410-971-0080    gwillis@em.umaryland.edu   
Contact: Linda H Barstow, PharmD    434-806-3162    LindaBarstow@umm.edu   
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: George C Willis, MD Director of Undergraduate Medical Education

Responsible Party: George Willis, MD FACEP, Director of Undergraduate Medical Education, University of Maryland
ClinicalTrials.gov Identifier: NCT02930044     History of Changes
Other Study ID Numbers: HP-00070969
First Posted: October 11, 2016    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual subject results will not be shared with those involved in the prospective arm.

Keywords provided by George Willis, University of Maryland:
Emergency department
Insulin
Adult

Additional relevant MeSH terms:
Diabetic Ketoacidosis
Ketosis
Acidosis
Acid-Base Imbalance
Metabolic Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Diabetes Complications
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs