Inpatient Self Monitoring and Administration Study (ISMAS)

NCT00506272 | Unknown DMC

• 1 other identifier: Emory IRB: 805-2006
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Hyperglycemia; Hypoglycemia

Keywords

diabetes mellitus; hyperglycemia; hypoglycemia; self care

Outcome Measures

Primary Outcomes (3)

• number of blood glucose measurements obtained/number of blood glucose measurements ordered

  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

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

• average blood glucose

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

Study Arms (2)

Standard care

EXPERIMENTAL

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

Patient administered care

EXPERIMENTAL

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

Interventions

Self blood glucose monitoring and insulin administration PROCEDURE

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

Patient administered care

Standard care PROCEDURE

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

Standard care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Atlanta VA Medical Center: lead

Study Sites (1)

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hyperglycemia; Hypoglycemia

Interventions

Blood Glucose Self-Monitoring; Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Peter M Thule, MD

  Atlanta VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Section Endocrinology

Study Record Dates

• First Submitted: July 23, 2007
• First Posted: July 25, 2007
• Study Start: December 1, 2007
• Primary Completion: December 1, 2016
• Last Updated: December 14, 2015

Record last verified: 2015-12

Locations

US (1)