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Inpatient Self Monitoring and Administration Study (ISMAS) (ISMAS)

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ClinicalTrials.gov Identifier: NCT00506272
Recruitment Status : Unknown
Verified December 2015 by Peter Thule, Atlanta VA Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : July 25, 2007
Last Update Posted : December 14, 2015
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Diabetes Mellitus Hyperglycemia Hypoglycemia Procedure: Self blood glucose monitoring and insulin administration Procedure: Standard care

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Inpatient Self Monitoring and Administration Study (ISMAS)
Study Start Date : December 2007
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 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.
Procedure: Standard care
finger-stick blood glucose values to be obtained and all insulin administration to be delivered by nursing staff
Experimental: 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.
Procedure: Self blood glucose monitoring and insulin administration
Patients will monitor blood glucose using a hand-held blood glucose monitor, and self-administer insulin


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. average blood glucose [ Time Frame: patients will be followed for the duration of hospital stay, an expected average of 5 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00506272


Locations
United States, Georgia
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
Atlanta VA Medical Center
Investigators
Principal Investigator: Peter M Thule, MD Atlanta VA Medical Center
More Information

Responsible Party: Peter Thule, Chief, Section Endocrinology, Atlanta VA Medical Center
ClinicalTrials.gov Identifier: NCT00506272     History of Changes
Other Study ID Numbers: Emory IRB: 805-2006
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: December 14, 2015
Last Verified: December 2015

Keywords provided by Peter Thule, Atlanta VA Medical Center:
diabetes mellitus
hyperglycemia
hypoglycemia
self care

Additional relevant MeSH terms:
Diabetes Mellitus
Hypoglycemia
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs