Veterans Inpatient Insulin Study and Transition to Outpatient Therapy
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 40 - 75 |
| Updated: | 10/19/2013 |
| Start Date: | February 2009 |
| End Date: | September 2011 |
| Contact: | Linda S Barber, RN, BSN |
| Email: | linda.barber2@va.gov |
| Phone: | (859)233-4511 |
Veterans Inpatient Insulin Study and Transition Algorithm: Efficacy of Insulin Analogs for Inpatient Glycemic Control and Transition to Outpatient Therapy
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 illness requiring hospitalization. If they volunteer to take part in
this study, they will be one of about 120 people to do so. The investigators hope to answer
the following research questions:
- To show that insulin aspart protamine 70/30 mix taken twice daily is as good as insulin
NPH/Reg 70/30 mix taken twice a day for treatment of diabetes after discharge from the
hospital.
- To show how safe the two medicines are (insulin aspart 70/30 mix vs. insulin NPH/Reg
70/30 mix) and how well they work for the treatment of diabetes when transitioning from
inpatient therapy to outpatient care.
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-four weeks after discharge from the hospital.
Inclusion Criteria:
- Diagnosed with type 2 diabetes for duration of three-months or longer
- 40-75 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 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 Criteria:
- 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.
We found this trial at
1
site
Click here to add this to my saved trials
