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

December 11, 2015 updated by: Peter Thule, Atlanta VA Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Atlanta VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
patients will be followed for the duration of hospital stay, an expected average of 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atlanta VA Medical Center

Investigators

  • Principal Investigator: Peter M Thule, MD, Atlanta VA Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

July 23, 2007

First Submitted That Met QC Criteria

July 23, 2007

First Posted (Estimate)

July 25, 2007

Study Record Updates

Last Update Posted (Estimate)

December 14, 2015

Last Update Submitted That Met QC Criteria

December 11, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Emory IRB: 805-2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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