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Inpatient Self Monitoring and Administration Study (ISMAS)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Atlanta VA Medical Center
ClinicalTrials.gov Identifier:
NCT00506272
First received: July 23, 2007
Last updated: August 11, 2011
Last verified: July 2007
  Purpose

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 Intervention
Diabetes Mellitus
Hyperglycemia
Hypoglycemia
Procedure: Self blood glucose monitoring and insulin administration
Procedure: Standard care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Inpatient Self Monitoring and Administration Study (ISMAS)

Resource links provided by NLM:


Further study details as provided by Atlanta VA Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • average blood glucose [ Time Frame: patients will be followed for the duration of hospital stay, an expected average of 5 days ] [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: December 2007
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Peter Thule, MD, Atlanta VA Medical Center
ClinicalTrials.gov Identifier: NCT00506272     History of Changes
Other Study ID Numbers: Emory IRB: 805-2006
Study First Received: July 23, 2007
Last Updated: August 11, 2011
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on November 20, 2014