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Completed

NCT Number: NCT00591227

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Subsequent finding of diabetic ketoacidosis or hyperosmolar non-ketotic syndrome after initial evaluation.
  • Patients with critical illness suspected to require intensive care unit admission or direct surgical intervention.
  • History of current drug or alcohol abuse.
  • History of current mental illness
  • Inability to give informed consent
  • Female patients who are pregnant or are breast feeding
  • Patients who have clinically significant liver disease with AST/ALT (aspartate transaminase/alanine transaminase) > 3 times the upper range of normal
  • Patients currently treated with dialysis

Treatment and study plan

insulin aspart

Drug

insulin aspart: 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.

insulin detemir

Drug

insulin 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.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.

Primary outcomes

  1. Hospital Length of Stay

    Time frame: from hospital admission to hospital discharge

    hospital length of stay in days

Secondary outcomes

  1. Average Blood Glucose During the Hospital Admission

    Time frame: from admission to discharge

  2. Frequency of Hypoglycemia

    Time frame: from hospital admission to discharge

  3. Efficacy of Blood Glucose Lowering During the Emergency Room Stay

    Time frame: from emergency room admission to discharge

  4. Frequency of Hypoglycemia During Emergency Room Therapy With Insulin

    Time frame: from emergency room admission to discharge

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • Novo Nordisk A/S

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 11, 2008
Registry last updated
Feb 7, 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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