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Insulin Delivery System

Insulin-Glucose Infusion System for High Blood Sugar

Phase 1 & 2

Waitlist Available

Led By Timothy W Valk, MD

Research Sponsored by Admetsys Corporation

Eligibility Criteria Checklist

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

Must have

Type 1 or type 2 diabetic individuals on insulin ages 21-85 with A1c 7-9.9%

Be older than 18 years old

Must not have

Poor intravenous access

Anemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up data will be evaluated within 6 months after completion of all 40 studies

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new system that regulates blood sugar levels without causing low blood sugar levels. The system will be used in intensive care units and during surgery.

Who is the study for?

This trial is for adults aged 21-85 with Type 1 or Type 2 diabetes, currently on insulin therapy, and have high blood sugar levels (>150 mg/dl) at the time of study. Their A1c levels should be between 7-9.9%. People who are pregnant, using corticosteroids, or have kidney/liver diseases, electrolyte imbalances, anemia or poor veins for drips cannot join.

What is being tested?

The study tests a system that balances glucose and insulin delivered directly into the bloodstream while frequently checking blood sugar levels. The goal is to maintain stable blood sugar without causing low blood sugar in patients in intensive care units or during surgery.

What are the potential side effects?

Potential side effects may include risks associated with maintaining tight control of blood sugar such as low blood sugar (hypoglycemia), especially since this involves frequent adjustments to insulin infusion based on real-time monitoring.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 21-85 years old with diabetes on insulin and my A1c is between 7-9.9%.

Exclusion Criteria

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

Select...

I have difficulty with IV insertions.

Select...

I have anemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ data will be evaluated within 6 months after all 40 studies are completed

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~data will be evaluated within 6 months after all 40 studies are completed

This trial's timeline: 3 weeks for screening, Varies for treatment, and data will be evaluated within 6 months after all 40 studies are completed for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

glucose control in target range

Secondary study objectives

hypoglycemia

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: insulin and glucose infusionExperimental Treatment1 Intervention

trial of experimental technique in outpatient setting; the group under study will be comprised of type 1 and type 2 diabetic individuals ; they will have automated treatment using algorithm which regulates balancing infusions of glucose and/or insulin intravenously without manual intervention; blood glucose target of 80-180 mg/dl will be guide for the automated system

0 / 3Eligibility criteria met