Inpatient Self Monitoring and Administration Study (ISMAS)



Status:Active, not recruiting
Conditions:Other Indications, Endocrine, Diabetes
Therapuetic Areas:Endocrinology, Other
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:December 2007

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ISMAS is designed to test the hypothesis that self management of insulin dependent diabetes
mellitus by selected patients admitted for elective surgery is more efficacious than
standard care with respect to overall glycemic control, attaining finger-stick blood sugars,
and administering insulin.


Inclusion criteria:

1. Male or female, age < 80

2. Most recent hemoglobin A1C within the past 6 months < 12%

3. Recent history of regular self-administered peripheral blood glucose checks as an
outpatient

4. Recent history of insulin self-administration at least twice a day as an outpatient

5. Admitted for a hospitalization anticipated to last at least 3 days

6. Mini Mental Status Examination (MMSE) ≥ 25 at admission and the same or better
post-operatively

7. All patients will be actively followed by the Endocrinology inpatient consultation
team during the hospitalization.

Exclusion criteria:

1. Currently receiving peritoneal or hemodialysis

2. Patients with unstable angina

3. History of myocardial infarction within 3 weeks prior to enrollment

4. Current admission due to or associated with altered mental status or encephalopathy

5. History of an episode of altered mental status or encephalopathy within the 4 weeks
prior to enrollment

6. A confirmed diagnosis of dementia

7. Inability to self-adjust insulin

8. No recent history of ability to perform regular peripheral blood glucose checks

9. Frequency of hypoglycemia (< 60 mg/dL) > twice/week by history

10. Inability to eat without assistance

11. Study objectives will not be pursued in patients during stays in any intensive care
unit.
We found this trial at
1
site
Decatur, Georgia 30033
?
mi
from
Decatur, GA
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