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Inpatient Self Monitoring and Administration Study (ISMAS)

NCT ID: NCT00506272

Last Updated: 2015-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

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.

Detailed Description

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Conditions

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Diabetes Mellitus Hyperglycemia Hypoglycemia

Keywords

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diabetes mellitus hyperglycemia hypoglycemia self care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Standard care

Intervention Type PROCEDURE

finger-stick blood glucose values to be obtained and all insulin administration to be delivered by nursing staff

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.

Group Type EXPERIMENTAL

Self blood glucose monitoring and insulin administration

Intervention Type PROCEDURE

Patients will monitor blood glucose using a hand-held blood glucose monitor, and self-administer insulin

Interventions

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Self blood glucose monitoring and insulin administration

Patients will monitor blood glucose using a hand-held blood glucose monitor, and self-administer insulin

Intervention Type PROCEDURE

Standard care

finger-stick blood glucose values to be obtained and all insulin administration to be delivered by nursing staff

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Atlanta VA Medical Center

FED

Sponsor Role lead

Responsible Party

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Peter Thule

Chief, Section Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter M Thule, MD

Role: PRINCIPAL_INVESTIGATOR

Atlanta VA Medical Center

Locations

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Atlanta VA Medical Center

Decatur, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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Emory IRB: 805-2006

Identifier Type: -

Identifier Source: org_study_id