Insulin-Glucose Infusion System for High Blood Sugar

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Admetsys Corporation

Must be taking: Insulin

Must not be taking: Corticosteroids

Disqualifiers: Pregnancy, Renal, Hepatic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to study the use of a counterbalancing system of glucose and insulin infusion with frequent blood glucose monitoring and combined adaptive algorithm can produce tight glycemic control without hypoglycemia; study to develop a closed loop for use in intensive care units and surgery

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking corticosteroids, you would not be eligible to participate.

What data supports the effectiveness of the Insulin Balanced Infusion System treatment for high blood sugar?

Research shows that advanced insulin infusion systems, like the Minimed 780G, can significantly improve blood sugar control in people with type 1 diabetes. Additionally, using insulin infusion protocols in critical care settings has been shown to improve outcomes by normalizing blood sugar levels. ^{1 2 3 4 5}

Is the Insulin-Glucose Infusion System safe for humans?

Insulin infusion systems, like insulin pumps, can have safety issues such as pump failure or user errors, which might lead to high or low blood sugar levels. While these systems are generally safe, they require careful use and monitoring to avoid potential risks. ^{6 7 8 9 10}

How is the Insulin Balanced Infusion System treatment different from other treatments for high blood sugar?

The Insulin Balanced Infusion System (IBIS) is unique because it is a new technology designed to optimize glucose control, which is often challenging with current methods. It likely involves a closed-loop system that continuously monitors blood sugar levels and adjusts insulin delivery automatically, similar to an artificial pancreas, offering more precise and responsive management of blood sugar levels. ^{1 11 12 13 14}

Research Team

Timothy W Valk, MD

Principal Investigator

Admetsys Corporation

Eligibility Criteria

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.

Inclusion Criteria

Your blood sugar level at the time of the study is higher than 150 mg/dl.

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

Exclusion Criteria

Pregnancy

Your body has abnormal levels of certain minerals like sodium or potassium.

I have kidney or liver disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive automated treatment using an algorithm that regulates balancing infusions of glucose and/or insulin intravenously without manual intervention

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Insulin Balanced Infusion System

Trial Overview 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.

Participant Groups

Group I: insulin and glucose infusion Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Admetsys Corporation

Lead Sponsor

Trials

1

Recruited

40+

Findings from Research

A comprehensive analysis of the National Reporting and Learning System database revealed that patient safety incidents involving insulin are common and lead to significant distress for individuals with diabetes and their families, highlighting a critical area for improvement in diabetes care.

The article discusses ongoing efforts by the National Patient Safety Agency and partner organizations aimed at reducing insulin-related errors, indicating a proactive approach to enhancing patient safety in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin, hospitals and harm: a review of patient safety incidents reported to the National Patient Safety Agency. Cousins, D., Rosario, C., Scarpello, J.[2021]

Insulin pump therapy (CSII) is crucial for managing type 1 diabetes, but it carries risks of serious complications like hyperglycemia and hypoglycemia due to various factors including pump failures and user errors.

There is a lack of transparency and sufficient data on the safety and long-term efficacy of insulin pumps, highlighting the need for better regulatory practices and more public funding for research to improve user education and prevent adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. Heinemann, L., Fleming, GA., Petrie, JR., et al.[2022]

In a study involving 169 patients with type 1 diabetes, Insuman was shown to be noninferior to Insuplant in terms of safety and effectiveness when used in implanted insulin pumps, with similar changes in HbA1c levels and infusion accuracy.

Both insulin preparations resulted in comparable rates of severe hypoglycemia and other adverse events, indicating that Insuman can be a safe alternative to Insuplant for long-term glucose control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of a new insulin preparation for implanted pumps used in the treatment of type 1 diabetes. Schaepelynck, P., Riveline, JP., Renard, E., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Minimed Medtronic 780G optimizes glucose control in patients with type 1 diabetes mellitus. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Assessment of quality of glycemic control in intensive care patients treated with an insulin infusion at a teaching hospital. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Insulin infusion protocol for critical care units. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Pathway for the management of hyperglycemia in critical care units. [2008]

5. United States pubmed.ncbi.nlm.nih.gov

Intensive insulin therapy in critical care: a review of 12 protocols. [2011]

6. England pubmed.ncbi.nlm.nih.gov

Insulin, hospitals and harm: a review of patient safety incidents reported to the National Patient Safety Agency. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Faster in and faster out: accelerating insulin absorption and action by insulin infusion site warming. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Improving Patient Experience With Insulin Infusion Sets: Practical Guidelines and Future Directions. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Assessment of a new insulin preparation for implanted pumps used in the treatment of type 1 diabetes. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Insulin-Based Infusion System: Advancing the Development. [2020]

12. Germany pubmed.ncbi.nlm.nih.gov

Development of a closed-loop artificial pancreas. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Control of insulin-dependent diabetes with portable miniaturized infusion systems. [2019]

14. Germany pubmed.ncbi.nlm.nih.gov

The use of artificial beta cell in diagnosis and treatment of insulinoma. [2018]