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Self-Managed Insulin for Diabetes (ISMAS Trial)

Q: Who qualifies to participate in this experiment?

This experiment seeks to recruit 1 test subject, from the age of 18 up until 80 years old, who has been diagnosed with hyperglycemia. Male and female participants should have a Mini Mental Status Examination (MMSE) score greater than or equal to 25 prior to being admitted for hospitalization that is expected to last at least 3 days. Additionally, <a href="https://www.withpower.com/clinical-trials/all">all</a> patients will be monitored by an Endocrinology inpatient consultation team throughout their stay.

Q: Are there still opportunities to enroll in this research study?

Affirmative, clinicaltrials.gov depicts that this medical research study is no longer recruiting patients.. The investigation was first documented on December 1st 2007 and most recently revised on December 11th 2015. Although the trial has ended, there are still 1277 other studies actively seeking participants now.

Q: Will elderly individuals be included in the trial population?

According to the criteria for inclusion in this trial, participants must be 18 years old or older and younger than 80.

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

ISMAS Trial 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.Check my eligibility

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.See study design

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.

ISMAS Trial 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.

ISMAS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and patients will be followed for the duration of hospital stay, an expected average of 5 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

average blood glucose

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

number of insulin doses administered/number of insulin doses prescribed

ISMAS 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

2005

Completed Phase 3

~9260

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Atlanta VA Medical CenterLead Sponsor

26 Previous Clinical Trials

69,434 Total Patients Enrolled

Peter M Thule, MDPrincipal InvestigatorAtlanta VA Medical Center

Media Library

Self blood glucose monitoring and insulin administration Clinical Trial Eligibility Overview. Trial Name: NCT00506272 — N/A

Diabetes Research Study Groups: Patient administered care, Standard care

Diabetes Clinical Trial 2023: Self blood glucose monitoring and insulin administration Highlights & Side Effects. Trial Name: NCT00506272 — N/A

Self blood glucose monitoring and insulin administration 2023 Treatment Timeline for Medical Study. Trial Name: NCT00506272 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who qualifies to participate in this experiment?

"This experiment seeks to recruit 1 test subject, from the age of 18 up until 80 years old, who has been diagnosed with hyperglycemia. Male and female participants should have a Mini Mental Status Examination (MMSE) score greater than or equal to 25 prior to being admitted for hospitalization that is expected to last at least 3 days. Additionally, all patients will be monitored by an Endocrinology inpatient consultation team throughout their stay."

Answered by AI

Are there still opportunities to enroll in this research study?

"Affirmative, clinicaltrials.gov depicts that this medical research study is no longer recruiting patients.. The investigation was first documented on December 1st 2007 and most recently revised on December 11th 2015. Although the trial has ended, there are still 1277 other studies actively seeking participants now."

Answered by AI