Inpatient Self Monitoring and Administration Study (ISMAS)

Study Overview
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Brief Summary
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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.

Official Title
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Inpatient Self Monitoring and Administration Study (ISMAS)

Conditions
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Diabetes Mellitus, Hyperglycemia, Hypoglycemia

Intervention / Treatment
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* Procedure: Self blood glucose monitoring and insulin administration
* Procedure: Standard care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard care<br>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. | Procedure: Standard care<br>* finger-stick blood glucose values to be obtained and all insulin administration to be delivered by nursing staff<br>|
| Experimental: Patient administered care<br>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. | Procedure: Self blood glucose monitoring and insulin administration<br>* Patients will monitor blood glucose using a hand-held blood glucose monitor, and self-administer insulin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, hyperglycemia, hypoglycemia, self care