Back to resultsInpatient Self Monitoring and Administration Study (ISMAS) (ISMAS)
Primary Purpose
Diabetes Mellitus, Hyperglycemia, Hypoglycemia
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self blood glucose monitoring and insulin administration
Standard care
Sponsored by
About this trial
This is an interventional health services research trial for Diabetes Mellitus focused on measuring diabetes mellitus, hyperglycemia, hypoglycemia, self care
Eligibility Criteria
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.
Sites / Locations
- Atlanta VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Standard care
Patient administered care
Arm 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.
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.
Outcomes
Primary Outcome Measures
number of blood glucose measurements obtained/number of blood glucose measurements ordered
number of insulin doses administered/number of insulin doses prescribed
average blood glucose
Secondary Outcome Measures
Full Information
NCT ID
NCT00506272
First Posted
July 23, 2007
Last Updated
December 11, 2015
Sponsor
Atlanta VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00506272
Brief Title
Inpatient Self Monitoring and Administration Study (ISMAS)
Acronym
ISMAS
Official Title
Inpatient Self Monitoring and Administration Study (ISMAS)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Atlanta VA Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Hyperglycemia, Hypoglycemia
Keywords
diabetes mellitus, hyperglycemia, hypoglycemia, self care
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard care
Arm Type
Experimental
Arm 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.
Arm Title
Patient administered care
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Self blood glucose monitoring and insulin administration
Intervention Description
Patients will monitor blood glucose using a hand-held blood glucose monitor, and self-administer insulin
Intervention Type
Procedure
Intervention Name(s)
Standard care
Intervention Description
finger-stick blood glucose values to be obtained and all insulin administration to be delivered by nursing staff
Primary Outcome Measure Information:
Title
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
Title
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
Title
average blood glucose
Time Frame
patients will be followed for the duration of hospital stay, an expected average of 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter M Thule, MD
Organizational Affiliation
Atlanta VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta VA Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Inpatient Self Monitoring and Administration Study (ISMAS)
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