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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
insulin aspart
insulin detemir
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 AST/ALT (aspartate transaminase/alanine transaminase) > 3 times the upper range of normal
  8. Patients currently treated with dialysis

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

aspart detemir

usual care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hospital Length of Stay
hospital length of stay in days

Secondary Outcome Measures

Average Blood Glucose During the Hospital Admission
Frequency of Hypoglycemia
Efficacy of Blood Glucose Lowering During the Emergency Room Stay
Frequency of Hypoglycemia During Emergency Room Therapy With Insulin

Full Information

First Posted
December 27, 2007
Last Updated
January 31, 2022
Sponsor
Rush University Medical Center
Collaborators
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00591227
Brief Title
Management of Diabetes in the Emergency Room: a Randomized Trial of an Insulin Protocol.
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
Collaborators
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
176 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aspart detemir
Arm Type
Active Comparator
Arm Description
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.
Arm Title
usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
insulin detemir
Intervention Description
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 Outcome Measure Information:
Title
Hospital Length of Stay
Description
hospital length of stay in days
Time Frame
from hospital admission to hospital discharge
Secondary Outcome Measure Information:
Title
Average Blood Glucose During the Hospital Admission
Time Frame
from admission to discharge
Title
Frequency of Hypoglycemia
Time Frame
from hospital admission to discharge
Title
Efficacy of Blood Glucose Lowering During the Emergency Room Stay
Time Frame
from emergency room admission to discharge
Title
Frequency of Hypoglycemia During Emergency Room Therapy With Insulin
Time Frame
from emergency room admission to discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Baldwin, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21661100
Citation
Bernard JB, Munoz C, Harper J, Muriello M, Rico E, Baldwin D. Treatment of inpatient hyperglycemia beginning in the emergency department: a randomized trial using insulins aspart and detemir compared with usual care. J Hosp Med. 2011 May;6(5):279-84. doi: 10.1002/jhm.866.
Results Reference
derived

Learn more about this trial

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

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