Inpatient Self Monitoring and Administration Study (ISMAS)

Status unconfirmed · Not applicable

Conditions studied: Diabetes Mellitus, Hyperglycemia, Hypoglycemia

In brief

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.

Key facts

Study ID

NCT00506272

Run by

Atlanta VA Medical Center

People needed

1

Starts

2007-12-01

Last updated by the study team

2015-12-14

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, age < 80
• Most recent hemoglobin A1C within the past 6 months < 12%
• Recent history of regular self-administered peripheral blood glucose checks as an outpatient
• Recent history of insulin self-administration at least twice a day as an outpatient
• Admitted for a hospitalization anticipated to last at least 3 days
• Mini Mental Status Examination (MMSE) ≥ 25 at admission and the same or better post-operatively
• All patients will be actively followed by the Endocrinology inpatient consultation team during the hospitalization.

You may not qualify if…

• Currently receiving peritoneal or hemodialysis
• Patients with unstable angina
• History of myocardial infarction within 3 weeks prior to enrollment
• Current admission due to or associated with altered mental status or encephalopathy
• History of an episode of altered mental status or encephalopathy within the 4 weeks prior to enrollment
• A confirmed diagnosis of dementia
• Inability to self-adjust insulin
• No recent history of ability to perform regular peripheral blood glucose checks
• Frequency of hypoglycemia (< 60 mg/dL) > twice/week by history
• Inability to eat without assistance
• Study objectives will not be pursued in patients during stays in any intensive care unit.

Where it is running

• Atlanta VA Medical Center — Decatur, Georgia, United States

Full record on ClinicalTrials.gov

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