Management of Diabetes in the Emergency Room: a Randomized Trial of an Insulin Protocol.

This study has been completed.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by:
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00591227
First received: December 27, 2007
Last updated: April 8, 2011
Last verified: April 2011
  Purpose

This study will examine two questions: 1. Whether insulin treatment of high blood sugar in patients with diabetes while they are in the emergency room will improve how quickly they recover from illness if they need to be hospitalized. 2. Whether immediately beginning long lasting insulin detemir in patients with diabetes when they are admitted to hospital from the emergency room will improve how quickly they recover from the illness which necessitated hospitalization.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: insulins aspart and detemir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Management of Hyperglycemia in the Emergency Room: A Randomized Clinical Trial of a Subcutaneous Insulin Aspart Protocol Coupled With Rapid Initiation of Basal Bolus Insulin Prior to Hospital Admission Versus Usual Care

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Length of Stay in the Hospital [ Time Frame: from hospital admission to hospital discharge ] [ Designated as safety issue: No ]
  • Hospital Length of Stay [ Time Frame: days ] [ Designated as safety issue: No ]
    hospital length of stay in days


Secondary Outcome Measures:
  • Average Blood Glucose During the Hospital Admission [ Time Frame: from admission to discharge ] [ Designated as safety issue: No ]
  • Frequency of Hypoglycemia [ Time Frame: from hospital admission to discharge ] [ Designated as safety issue: Yes ]
  • Efficacy of Blood Glucose Lowering During the Emergency Room Stay [ Time Frame: from emergency room admission to discharge ] [ Designated as safety issue: No ]
  • Frequency of Hypoglycemia During Emergency Room Therapy With Insulin [ Time Frame: from emergency room admission to discharge ] [ Designated as safety issue: Yes ]

Enrollment: 176
Study Start Date: May 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1-aspart detemir
these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.
Drug: insulins aspart and detemir
insulin aspart will be given every 2 hours dosed from 0.05 to 0.15 units per kg weight to patients with a prior history of diabetes if blood glucose is more than 200 mg/dl in the ER. If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating.
No Intervention: 2 usual care
these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-80 years
  2. History of type 2 diabetes mellitus for at least 3 months
  3. Prior therapy with dietary management, oral agents, or insulin
  4. Non child-bearing potential or a negative urine pregnancy test
  5. Initial blood glucose in ER > 200 mg/dl

Exclusion Criteria:

  1. Subsequent finding of diabetic ketoacidosis or hyperosmolar non-ketotic syndrome after initial evaluation.
  2. Patients with critical illness suspected to require intensive care unit admission or direct surgical intervention.
  3. History of current drug or alcohol abuse.
  4. History of current mental illness
  5. Inability to give informed consent
  6. Female patients who are pregnant or are breast feeding
  7. Patients who have clinically significant liver disease with ALT/AST > 3 times the upper range of normal
  8. Patients currently treated with dialysis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00591227

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Novo Nordisk A/S
Investigators
Principal Investigator: David Baldwin, MD Rush University Medical Center
  More Information

No publications provided by Rush University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Baldwin MD Director of Section of Endocrinology, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00591227     History of Changes
Other Study ID Numbers: 07070902
Study First Received: December 27, 2007
Results First Received: April 8, 2011
Last Updated: April 8, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin Aspart
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014