Inpatient Self Monitoring and Administration Study (ISMAS)

Diabetes Mellitus Clinical Trial

— ISMAS  

Official title:

Inpatient Self Monitoring and Administration Study (ISMAS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00506272
• Other study ID #: Emory IRB: 805-2006
• Status: Active, not recruiting
• Phase: N/A
• First received: July 23, 2007
• Last updated: December 11, 2015
• Start date: December 2007

Study information

• Verified date: December 2015
• Source: Atlanta VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hyperglycemia
• Hypoglycemia

Intervention

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

Locations

Country	Name	City	State
United States	Atlanta VA Medical Center	Decatur	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Atlanta VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	average blood glucose		patients will be followed for the duration of hospital stay, an expected average of 5 days	Yes