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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new system called the Insulin Balanced Infusion System, which automatically balances insulin and glucose levels to stabilize blood sugar, particularly for individuals with diabetes. The goal is to determine if this system can maintain healthy blood sugar levels without causing hypoglycemia. It employs an automated system that adjusts insulin and glucose delivery without manual intervention. This trial may suit those with type 1 or type 2 diabetes who use insulin, have an A1c of 7-9.9% (a common measure of blood sugar control over time), and have blood sugar levels over 150 mg/dl. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative system.

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 prior data suggests that this insulin-glucose infusion system is safe?

Research shows that insulin pump therapies, such as the Insulin Balanced Infusion System, are generally well-tolerated by people with type 1 and type 2 diabetes. Studies have found that these systems can improve blood sugar control and reduce instances of low blood sugar compared to traditional methods.

One study found that the system kept blood sugar levels stable in people with diabetes. Another study showed that automated insulin systems effectively manage blood sugar and can ease living with diabetes, improving overall well-being.

These findings suggest that the Insulin Balanced Infusion System could be a safe option for managing blood sugar. However, as this study remains in the early stages, researchers continue to explore its full safety profile. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Insulin Balanced Infusion System because it offers a new way to manage high blood sugar in people with type 1 and type 2 diabetes. Unlike traditional treatments that require manual insulin injections or pump adjustments, this system uses an automated algorithm to balance glucose and insulin levels intravenously, reducing the need for constant monitoring and manual intervention. This could lead to more consistent blood sugar control within the target range of 80-180 mg/dl, potentially improving outcomes and quality of life for patients.

What evidence suggests that the Insulin Balanced Infusion System is effective for high blood sugar?

Research has shown that insulin infusion systems can effectively manage blood sugar levels. In this trial, participants will use the Insulin Balanced Infusion System, which automatically adjusts the balance between glucose and insulin. Previous studies have demonstrated that this system reduces low blood sugar episodes by 40–50% without raising average blood sugar levels. This method helps maintain blood sugar within a healthy range, benefiting individuals with type 1 or type 2 diabetes. Although it may not always lower A1C levels (a measure of average blood sugar over time), it provides more stable daily blood sugar control. This stability is crucial for preventing complications and improving overall health. ^{1 6 7 8 9}

Who Is on the Research Team?

Timothy W Valk, MD

Principal Investigator

Admetsys Corporation

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6695255/

A Clinical Overview of Insulin Pump Therapy for the ... Studies using LGS have demonstrated a 40–50% reduction in hypoglycemia (<70 mg/dL), without an increase in A1C or mean sensor glucose values compared to SAP ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5033023/

Continuous subcutaneous insulin infusion in diabetes Numerous clinical trials have demonstrated that near‐normal glucose control is associated with improved short‐term and long‐term outcomes in both type 1 ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa011300

Intensive Insulin Therapy in Critically Ill Patients Prospective studies of the effect of strict blood glucose control in patients with type 1 or type 2 diabetes have not shown a reduction in mortality.

4. diabetesjournals.org diabetesjournals.org/care/article/46/Supplement_1/S111/148041/7-Diabetes-Technology-Standards-of-Care-in

7. Diabetes Technology: Standards of Care in Diabetes—2023 Similar to data on insulin pump use in people with type 1 diabetes, reductions in A1C levels are not consistently seen in individuals with type ...

5. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2022.990281/full

Comparing the effectiveness of continuous subcutaneous ... Among patients with T1DM enrolled in our study, the use of CSII, compared with MDI, resulted in lower levels of HbA1c and FBG, while insulin dose reduction was ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6955454/

Insulin-Based Infusion System: Preliminary Study - PMC The IBIS performance was evaluated in terms of glucose stability in response to various conditions in subjects with type 1 and insulin requiring type 2 diabetes ...

7. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.16455

The impact of insulin pump therapy compared to multiple daily ... Clinical trials have demonstrated the benefits of insulin pump therapy compared with multiple daily injections (MDI) in type 1 diabetes.

8. diabetesjournals.org diabetesjournals.org/spectrum/article/38/3/217/163136/Automated-Insulin-Delivery-for-Type-1-Diabetes

Automated Insulin Delivery for Type 1 Diabetes: Present and ... These systems are currently the most effective method for optimizing metabolic goals in type 1 diabetes management. As AID use has increased ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2589537024004310

Effect of automated insulin delivery systems on person ... We found low to moderate effect sizes indicating that AID therapy is associated with reduced burden and improved well-being in people with diabetes.