Inpatient Self Monitoring and Administration Study (ISMAS)

Atlanta VA Medical Center

Status: Unknown

Conditions: Hypoglycemia; Hyperglycemia; Diabetes Mellitus

Treatments: Procedure: Standard care; Procedure: Self blood glucose monitoring and insulin administration

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00506272

Emory IRB: 805-2006

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Standard care

Experimental group

Description:

Patients admitted for elective surgery will receive standard diabetes care, including but not limited to finger stick blood glucose determinations, and insulin injections delivered by the nursing staff.

Treatment:

Procedure: Standard care

Patient administered care

Experimental group

Description:

Patients will self-monitor and record finger-stick blood glucose measurements, and self administer insulin at doses agreed upon with the consulting endocrinology in-patient service.

Treatment:

Procedure: Self blood glucose monitoring and insulin administration