This trial is active, not recruiting.

Conditions diabetes mellitus, hyperglycemia, hypoglycemia
Treatments self blood glucose monitoring and insulin administration, standard care
Sponsor Atlanta VA Medical Center
Start date December 2007
End date December 2016
Trial size 1 participant
Trial identifier NCT00506272, Emory IRB: 805-2006


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
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.
standard care
finger-stick blood glucose values to be obtained and all insulin administration to be delivered by nursing staff
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.
self blood glucose monitoring and insulin administration
Patients will monitor blood glucose using a hand-held blood glucose monitor, and self-administer insulin

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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

Official title Inpatient Self Monitoring and Administration Study (ISMAS)
Principal investigator Peter M Thule, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Atlanta VA Medical Center.