Inpatient Self Monitoring and Administration Study (ISMAS)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Atlanta VA Medical Center
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- number of blood glucose measurements obtained/number of blood glucose measurements ordered
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Standard care
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.
Intervention: Standard care (Procedure)
Patient administered care
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.
Intervention: Self blood glucose monitoring and insulin administration (Procedure)
Outcomes
Primary Outcomes
number of blood glucose measurements obtained/number of blood glucose measurements ordered
Time Frame: patients will be followed for the duration of hospital stay, an expected average of 5 days
number of insulin doses administered/number of insulin doses prescribed
Time Frame: patients will be followed for the duration of hospital stay, an expected average of 5 days
average blood glucose
Time Frame: patients will be followed for the duration of hospital stay, an expected average of 5 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Peter Thule
Chief, Section Endocrinology
Atlanta VA Medical Center