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Self-Managed Insulin for Diabetes (ISMAS Trial)

N/A

Waitlist Available

Led By Peter M Thule, MD

Research Sponsored by Atlanta VA Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Admitted for a hospitalization anticipated to last at least 3 days

Recent history of insulin self-administration at least twice a day as an outpatient

Must not have

History of myocardial infarction within 3 weeks prior to enrollment

Inability to eat without assistance

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether patients with diabetes can manage their own insulin during surgery, and if so, whether it's more effective than the standard care for blood sugar control.

Who is the study for?

The ISMAS trial is for men and women under 80 with diabetes who self-administer insulin twice daily, have an A1C < 12% from the last 6 months, can check their blood sugar themselves, and are mentally sharp (MMSE ≥ 25). They must be in hospital for at least 3 days but not in intensive care or on dialysis. Those with frequent low blood sugar episodes, recent heart attacks, dementia, or unable to adjust their own insulin are excluded.

What is being tested?

ISMAS compares two approaches: patients managing their own blood glucose levels and insulin doses versus receiving standard hospital care. The goal is to see which method leads to better control of blood sugar levels during a hospital stay for surgery.

What are the potential side effects?

Potential side effects may include risks associated with incorrect insulin dosing such as very low or high blood sugar levels. Standard care side effects depend on the usual hospital procedures but could involve less personalized management of diabetes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am in the hospital and expected to stay for at least 3 days.

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I have been taking insulin injections by myself at least twice a day recently.

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I am younger than 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a heart attack in the last 3 weeks.

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I need help to eat.

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I am currently admitted to the hospital because of changes in my mental state or brain function.

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I am currently on dialysis.

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I have unstable chest pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard careExperimental Treatment1 Intervention

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 II: Patient administered careExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Standard care

2007

Completed Phase 4

~9600

0 / 8Eligibility criteria met