Status:
COMPLETED
Veterans Inpatient Insulin Study and Transition to Outpatient Therapy
Lead Sponsor:
Dennis G. Karounos, M.D.
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
Volunteers are being invited to take part in a research study about insulin therapy of diabetes. They are being invited to take part in this research study because they have diabetes and have an illne...
Detailed Description
By doing this study, we hope to learn the optimal way to use insulin therapy to treat individuals during a hospitalization for an illness as well as during the recovery phase of the illness for twenty...
Eligibility Criteria
Inclusion
- Diagnosed with type 2 diabetes for duration of three-months or longer
- greater than or equal to 40 years of age
- Written informed consent to participate in the study
- Admitted for hospitalization at VA Medical Center Lexington, KY
- Able and willing to do the following:
- Use the insulin injection device provided to you as you are instructed
- Check your blood sugar as instructed using the blood sugar monitor and send the results by a glucose log or a telephone transmitter provided to you for use during the study
- Enter your information in a diary provided to you
- You have an acute non-critical medical illness requiring inpatient hospitalization (at least 24 hour admission) with a blood glucose between 140 and 400 mg/dl.
- You require further hospitalization after being released from intensive care unit for an acute illness
Exclusion
- Have developed a severe illness requiring treatment in an intensive care unit as determined by your admitting physician.
- Are pregnant or intend to become pregnant during this study, or are a sexually active woman who could become pregnant and are not practicing a birth control method considered acceptable by your study doctor for preventing pregnancy.
- Are a woman who is breastfeeding.
- Have a history of heart disease that limits your physical activity
- Have had a kidney transplant or are currently receiving kidney dialysis
- Have history of cancer other than minor skin cancer.
- Have had a blood transfusion or severe loss of blood in the past 3 months or have any disease of the blood system.
- Are allergic or sensitive to study insulin.
- Are currently receiving oral steroid therapy.
- Are currently on any other investigational medications or investigational protocols
- Have drug or alcohol abuse that in the investigator's opinion would cause the individual to be non-compliant.
- Are poorly compliant with the currently prescribed diabetes regimen or self monitoring of blood glucose, as defined by the investigator.
- Have a mental condition that renders you unable to understand the scope and possible consequences of the study.
Key Trial Info
Start Date :
March 11 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2013
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00821795
Start Date
March 11 2009
End Date
April 23 2013
Last Update
March 4 2020
Active Locations (1)
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1
VA Medical Center - Lexington 596
Lexington, Kentucky, United States, 40502