Artificial Pancreas Systems for Type 1 Diabetes

No longer recruiting at 2 trial locations

Overseen By Deborah Branigan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Must be taking: Insulin

Must not be taking: Beta blockers, Corticosteroids

Disqualifiers: Cardiovascular disease, Renal insufficiency, Liver disease, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new system to help people with type 1 diabetes manage blood sugar levels. The system uses an artificial pancreas (MPC closed-loop system) that automatically delivers insulin, even if a meal is missed. Participants will either use this new system or continue their current insulin pump routine for comparison. Ideal candidates have managed type 1 diabetes for at least a year and currently use a specific insulin pump system. As an unphased trial, this study allows participants to contribute to innovative diabetes management research.

Do I have to stop taking my current medications for the trial?

The trial requires you to stop taking any medication intended to lower glucose other than insulin, such as metformin or liraglutide. You also cannot use beta blockers, non-dihydropyridine calcium channel blockers, or corticosteroids. If you're on any of these, you would need to stop them to participate.

What prior data suggests that this artificial pancreas system is safe for managing Type 1 Diabetes?

Studies have shown that the MPC closed-loop system, a type of artificial pancreas, is generally well-tolerated by patients. Research on this system's safety in a clinical setting found it effectively managed blood sugar levels without causing major problems. Participants did not report serious side effects, indicating the system is safe for people with type 1 diabetes. However, as with any new technology, individual experiences may vary, so participants should monitor their body's reactions if they choose to participate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MPC closed-loop system for Type 1 Diabetes because it offers a more automated approach to managing blood sugar levels. Unlike traditional insulin pumps, which require manual adjustments, the MPC system uses advanced algorithms to continuously monitor glucose levels and adjust insulin delivery in real-time. This closed-loop system, also known as an artificial pancreas, aims to reduce the burden of constant self-management and improve blood sugar control. By using Fiasp insulin, which acts faster than regular insulin, it has the potential to keep glucose levels within a tighter range, offering better overall management for people with Type 1 Diabetes.

What evidence suggests that this trial's treatments could be effective for Type 1 Diabetes?

Research shows that the MPC closed-loop system, which trial participants may use, can help people with Type 1 Diabetes manage their blood sugar more effectively. Studies have found that this system greatly improves blood sugar control, especially at night, and helps maintain levels within the target range more often. The MPC system uses a smart algorithm to connect devices that automatically adjust insulin delivery based on blood sugar levels. Widely used, this system is known to maintain better blood sugar levels, reducing the risk of high or low blood sugar episodes. These findings suggest that the system could offer better daily control for those with Type 1 Diabetes. ^{1 3 4 6 7}

Who Is on the Research Team?

Leah Wilson, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

Adults over 18 with Type 1 Diabetes, living within 40 miles of the study site, who have been using a t:slim X2 insulin pump and Dexcom G6 CGM with Control IQ for at least 12 weeks. They must not be pregnant or planning pregnancy without proper contraception, have an HbA1c between ≥7.5% and ≤10%, no severe liver disease, infections, seizure disorders, recent drug trials participation, bleeding issues or allergies to Fiasp insulin.

Inclusion Criteria

I have been using a t:slim X2 insulin pump with Dexcom G6 and Control IQ for at least 12 weeks.

Lives with another person age 18 or older who will sleep in the house at night and that can attend the training on using the system

Lives within 40 miles of enrollment site

Exclusion Criteria

I have not had major surgery in the last 30 days.

I have had diabetic ketoacidosis in the last 6 months.

I am not on long-term immunosuppressive medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention Period

Participants will use the MPC closed-loop system for 7 days using Fiasp insulin. The first 6 hours will be spent in clinic being trained on the system, then eating a meal. Then the participant will take the system home to continue using for 7 days.

7 days

1 visit (in-person), remainder at home

Control Period

Participants will continue their normal diabetes regimen which includes the t:slim X2 pump with Dexcom G6 CGM and Control IQ for 7 days. Participants will share their pump download and Dexcom Clarity data with study staff after the 7 days is complete.

7 days

1 visit (in-person), remainder at home

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MPC closed-loop system
• t:slim X2 pump with Dexcom G6 CGM and Control IQ

Trial Overview The trial is testing a new missed meal bolus detection algorithm in an artificial pancreas system against usual care involving the t:slim X2 pump with Control IQ technology. The goal is to see if this new feature can better manage glucose levels in high-risk patients by automatically delivering insulin when meals are detected but not reported by users.

How Is the Trial Designed?

Group I: MPC Arm Experimental Treatment 1 Intervention

Participants will use the MPC closed-loop system for 7 days using Fiasp insulin. The first 6 hours will be spent in clinic being trained on the system, then eating a meal. Then the participant will take the system home to continue using for 7 days.

Group II: Control IQ arm Active Control 1 Intervention

Participants will continue their normal diabetes regimen which includes the t:slim X2 pump with Dexcom G6 CGM and Control IQ for 7 days. Participants will share their pump download and Dexcom Clarity data with study staff after the 7 days is complete.

MPC closed-loop system is already approved in United States, European Union, Canada for the following indications:

Approved in United States as t:slim X2 insulin pump with Control-IQ technology for:

• Type 1 diabetes mellitus

Approved in European Union as t:slim X2 insulin pump with Control-IQ technology for:

• Type 1 diabetes mellitus

Approved in Canada as t:slim X2 insulin pump with Control-IQ technology for:

• Type 1 diabetes mellitus

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

MultiCare Rockwood Northpointe Specialty Center

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

The novel Model Predictive Control (MPC) law for an Artificial Pancreas effectively manages blood glucose levels in people with type 1 diabetes by using asymmetric input costs to enhance safety during both hyperglycemia and hypoglycemia.

In a clinical trial involving 32 subjects, the MPC law demonstrated its ability to predictively suspend and resume insulin delivery, showcasing its potential for safe outpatient use in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Periodic zone-MPC with asymmetric costs for outpatient-ready safety of an artificial pancreas to treat type 1 diabetes. Gondhalekar, R., Dassau, E., Doyle, FJ.[2020]

The model predictive control (MPC) algorithm effectively managed blood glucose levels in six Type 1 diabetes patients, successfully bringing hyperglycemia to normoglycemia within 2 to 3 hours during fasting conditions.

Both intravenous and simulated subcutaneous glucose monitoring routes achieved similar glucose control outcomes, maintaining levels within the physiological range, indicating the MPC's adaptability and efficacy in different monitoring scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On-line adaptive algorithm with glucose prediction capacity for subcutaneous closed loop control of glucose: evaluation under fasting conditions in patients with Type 1 diabetes. Schaller, HC., Schaupp, L., Bodenlenz, M., et al.[2011]

The adaptive model predictive control (MPC) strategy using a run-to-run (R2R) approach significantly improved glucose control in type 1 diabetes, increasing time in range by 11.39% and reducing time spent above 180 mg/dl by 48.74% over two months in silico simulations.

This approach effectively managed the large glucose variability typical in type 1 diabetes without increasing the risk of hypoglycemia, highlighting its potential for real-life outpatient use in future artificial pancreas studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward a Run-to-Run Adaptive Artificial Pancreas: In Silico Results. Toffanin, C., Visentin, R., Messori, M., et al.[2019]

The proposed adaptive model predictive control (MPC) algorithm for artificial pancreas systems dynamically adjusts insulin delivery based on real-time estimates of plasma insulin concentration, enhancing the system's responsiveness to changing glucose levels.

In simulation studies, the adaptive MPC effectively optimized insulin delivery while incorporating safety constraints to prevent overdosing, demonstrating improved efficacy in managing blood sugar levels without needing manual meal input.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma-Insulin-Cognizant Adaptive Model Predictive Control for Artificial Pancreas Systems. Hajizadeh, I., Rashid, M., Cinar, A.[2020]

Model predictive control (MPC) offers significant advantages for developing a closed-loop artificial pancreas, such as the ability to incorporate constraints on insulin delivery and adapt to various factors like meals and exercise.

The success of an artificial pancreas relies not only on the choice of control algorithm, whether MPC or PID, but also on the engineers' experience in implementing these algorithms in real human studies, highlighting the importance of practical application over theoretical simulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Algorithms for a closed-loop artificial pancreas: the case for model predictive control. Bequette, BW.[2021]

The proposed enhancements to the artificial pancreas controller significantly improved blood glucose management, increasing the time spent in the safe glycemic range (70-180 mg/dL) from 68.8% to 76.9% without increasing hypoglycemia risk.

These advancements include a personalized insulin-blood glucose model, an asymmetric cost function to prioritize preventing hypoglycemia, and a dynamic insulin-on-board algorithm, all of which were validated through both in silico tests and clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced Model Predictive Control (eMPC) Strategy for Automated Glucose Control. Lee, JB., Dassau, E., Gondhalekar, R., et al.[2019]

The model predictive control (MPC) algorithm for an artificial pancreas significantly improved glucose control in outpatients with type 1 diabetes, increasing the percentage of time spent in the target glucose range by 10.03% during overnight use.

The MPC-based system also demonstrated safety by reducing the time spent in the hypoglycemic range by 1.34% over long-term use (more than 1 month), indicating it effectively manages blood sugar levels without increasing the risk of low blood sugar.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of a model predictive control (MPC) algorithm for an artificial pancreas system in outpatients with type 1 diabetes (T1D): systematic review and meta-analysis. Kang, SL., Hwang, YN., Kwon, JY., et al.[2022]

The novel Model Predictive Control (MPC) law for the Artificial Pancreas significantly enhances safety by reducing the risk of hypoglycemia while also improving the correction of hyperglycemia, addressing two critical challenges in diabetes management.

This MPC law was tested in four FDA-approved clinical trials, with the largest involving 29 participants over three months, demonstrating its effectiveness in real-world settings compared to previous strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Velocity-weighting & velocity-penalty MPC of an artificial pancreas: Improved safety & performance. Gondhalekar, R., Dassau, E., Doyle, FJ.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9733359/

Effectiveness and safety of a model predictive control (MPC ... Overnight use of the MPC-based artificial pancreas system statistically significantly improved glucose control while increasing time maintained ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10271231/

The Artificial Pancreas and Type 1 Diabetes - PMC The artificial pancreas or closed-loop system connects these devices via a control algorithm programmed to maintain target glucose.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0967066123003799?via=ihub

Model Predictive Control (MPC) of an artificial pancreas ... Closed-loop insulin delivery strategies helps regulate glycemia in Type 1 Diabetes. •. Model predictive control (MPC) is widely used in this context. •.

4. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT01472406?term=animas&rank=2

Feasibility Study Using Zone-MPC Controller (Zone-Model ... The study consists of an evaluation of the Artificial Pancreas device during a 24-hour closed-loop in a clinic environment (Sansum Diabetes Research Institute, ...

5. diabetesjournals.org diabetesjournals.org/care/article/46/7/1425/148936/At-Home-Use-of-a-Pregnancy-Specific-Zone-MPC

At-Home Use of a Pregnancy-Specific Zone-MPC Closed ... This study aimed to evaluate the feasibility and performance of at-home use of a zone model predictive controller–based closed-loop insulin delivery system

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01472406

Feasibility Study Using Zone-MPC Controller (Zone-Model ... The study consists of an evaluation of the Artificial Pancreas device during a 24-hour closed-loop in a clinic environment (Sansum Diabetes Research Institute, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02438670

MPC Versus PID for Closed Loop Insulin Delivery The goal of this proposed study is to compare use of a PID (Proportional-Integral-Derivative) controller versus an MPC (Model Predictive Control) controller ...