Diabetes Mellitus, Hyperglycemia, Hypoglycemia
Conditions
Keywords
diabetes mellitus, hyperglycemia, hypoglycemia, self care
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.
Interventions
PROCEDUREStandard care
finger-stick blood glucose values to be obtained and all insulin administration to be delivered by nursing staff
PROCEDURESelf blood glucose monitoring and insulin administration
Patients will monitor blood glucose using a hand-held blood glucose monitor, and self-administer insulin
Sponsors
Atlanta VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of blood glucose measurements obtained/number of blood glucose measurements ordered | 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 | patients will be followed for the duration of hospital stay, an expected average of 5 days |
| average blood glucose | patients will be followed for the duration of hospital stay, an expected average of 5 days |
Countries
United States
Outcome results
None listed