Insulin Pump System for Type 1 Diabetes

(STAR-T1D Trial)

Recruiting at 2 trial locations

Overseen By Estelle M Everett, MD, MHS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Comorbidities, Cognitive impairment, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether a special insulin pump system can assist people with type 1 diabetes (T1D) who struggle to maintain stable blood sugar levels. It targets individuals with an A1c level over 8.5%, indicating prolonged high blood sugar. Participants will use a hybrid closed-loop insulin pump system, which automatically adjusts insulin levels, and attend regular education sessions on diabetes management. The trial seeks participants who have not previously used an insulin pump, speak English or Spanish, and have medical insurance. As an unphased trial, this study provides a unique opportunity for participants to access innovative diabetes management technology and contribute to valuable research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this insulin pump system is safe for patients with poorly controlled Type 1 Diabetes?

Research has shown that hybrid closed-loop insulin pump systems are generally safe for people with type 1 diabetes. These systems improve blood sugar control and are user-friendly. For instance, users often experience more time with their blood sugar in a healthy range and worry less about severe low blood sugar (hypoglycemia). Tested in everyday life, these systems have demonstrated positive results over time, making them a promising option for managing diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Hybrid Closed Loop (HCL) Insulin Pump System for Type 1 Diabetes because it automates insulin delivery in a way that current treatments don't. Unlike traditional insulin pumps or multiple daily injections, which require constant manual adjustments, the HCL system uses a continuous glucose monitor (CGM) to automatically adjust insulin levels based on real-time blood sugar readings. This can help maintain more stable blood sugar levels and reduce the risk of hypoglycemia. Additionally, the HCL system simplifies diabetes management, which could improve quality of life for users by reducing the burden of constant monitoring and manual dosing.

What evidence suggests that the Hybrid Closed Loop Insulin Pump System is effective for Type 1 Diabetes?

Studies have shown that hybrid closed-loop (HCL) insulin pump systems help people with type 1 diabetes better control their blood sugar levels. In this trial, participants in the experimental arm will use the HCL insulin pump system. Research indicates that these systems help users spend more time with their blood sugar in the target range and reduce their HbA1c levels, which reflect average blood sugar over a few months. HCL systems achieve this by automatically adjusting insulin delivery, preventing severe low blood sugar episodes. Evidence from multiple studies shows that these systems are effective for both children and adults. Overall, HCL systems can make managing diabetes easier and more effective. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for diverse adult patients with poorly controlled Type 1 Diabetes (HbA1c >8.5%) who are not currently using an insulin pump, speak English or Spanish, and have medical insurance coverage.

Inclusion Criteria

Not insulin pump user

Primary language of English or Spanish

Have medical insurance coverage

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive hybrid closed-loop insulin pump therapy with at least 6 sessions over 6 weeks, covering self-management basics, carb counting, CGM interpretation, hypoglycemia and hyperglycemia management, and troubleshooting device issues.

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for adherence, adverse effects, and device safety issues. A1c is repeated at 12 and 24 weeks, with follow-up questionnaires administered.

24 weeks

Visits at 1-4 week intervals

Long-term Follow-up

Participants continue to be monitored for safety and effectiveness, with assessments of treatment burden and satisfaction.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Hybrid Closed Loop Insulin Pump System

Trial Overview

The study tests a Hybrid Closed Loop Insulin Pump System in adults with high-need Type 1 Diabetes to see if it can reduce care burdens and improve management of the condition.

How Is the Trial Designed?

Group I: Hybrid Closed Loop Insulin Pump System Experimental Treatment 1 Intervention

Participants will meet 1:1 with our CDE for at least 6 sessions over 6 weeks. Sessions will cover self-management basics, carb counting, CGM interpretation, hypoglycemia and hyperglycemia management and troubleshooting device issues. The investigators will follow up with participants in 24 and 72 hours after CGM and insulin pump initiation, respectively, to answer any device related questions that may arise in between sessions. Participants will follow up at intervals of 1-4 weeks throughout the study. During visits, the investigators will assess for adherence and adverse effects and evaluate device and safety issues associated with pump settings in the HCL arm. The investigators will repeat A1c at 12 weeks and 24 weeks and administer follow up questionnaires at 12 and 24 weeks.

Group II: Control Active Control 1 Intervention

Participants in the control arm will receive diabetes education at a similar frequency as the intervention group. Diabetes education for the control group will be a combination of in-person visits with the CDE and telephone brief diabetes education sessions. Participants will follow up at intervals of 1-4 weeks throughout the study. During visits, the investigators will assess for adherence and adverse effects. The investigators will repeat A1c at 12 weeks and 24 weeks and administer follow up questionnaires at 12 and 24 weeks.

Hybrid Closed Loop Insulin Pump System is already approved in United States, European Union for the following indications:

Approved in United States as Hybrid Closed Loop Insulin Pump System for:

• Type 1 Diabetes management

Approved in European Union as Hybrid Closed Loop Insulin Pump System for:

• Type 1 Diabetes management

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Collaborator

Trials

105

Recruited

46,600+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Olive View-UCLA Education & Research Institute

Collaborator

Trials

34

Recruited

880,000+

Published Research Related to This Trial

In a study involving 251 children and young people with type 1 diabetes, the use of hybrid closed-loop (HCL) systems for 6 months led to significant improvements in glycemic control, time-in-range (TIR), and reduced frequency of hypoglycemia.

The HCL systems also positively impacted the quality of life for both the children and their parents, improving sleep quality and reducing fear of hypoglycemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real world use of hybrid-closed loop in children and young people with type 1 diabetes mellitus-a National Health Service pilot initiative in England. Ng, SM., Wright, NP., Yardley, D., et al.[2023]

The enhanced hybrid closed loop (e-HCL) insulin delivery system showed a significant reduction in closed loop exits and alerts compared to the standard hybrid closed loop (s-HCL) system in a study involving 11 adults with type 1 diabetes.

While e-HCL tended to improve time in target glucose range and mean glucose levels, these improvements were not statistically significant, and importantly, no severe hypoglycemia or ketoacidosis episodes occurred, indicating safety in its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glucose Control Using a Standard Versus an Enhanced Hybrid Closed Loop System: A Randomized Crossover Study. Paldus, B., Lee, MH., Jones, HM., et al.[2022]

A study of 71 hospitalized patients using hybrid closed-loop (HCL) insulin delivery systems found that their glycemic control was comparable to those using manual insulin pumps or basal-bolus therapy, indicating effective management of blood sugar levels.

The use of HCL technology in the hospital setting was deemed safe, with no reported adverse events such as diabetic ketoacidosis or pump-related complications, suggesting that these systems can be continued during hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid Closed-Loop Insulin Pump Technology Can Be Safely Used in the Inpatient Setting. Pelkey, MN., Boyle, ME., Long, A., et al.[2023]

In a case series of four adolescent patients using hybrid closed loop (HCL) systems for type 1 diabetes management, incorrect behaviors such as fabricated sensor calibrations and improper insulin bolusing were observed, highlighting potential risks even in automated therapies.

The HCL system was able to correct glucose levels in three out of four cases, indicating its robustness; however, excessive fabricated calibrations led to a failure in maintaining glycemic balance in one patient, suggesting that accurate sensor data is crucial for optimal system performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adolescents with type 1 diabetes vs. hybrid closed loop systems: a case series of patients' behaviour that challenges the algorithm. Zanfardino, A., Piscopo, A., Gizzone, P., et al.[2023]

In a study of 230 individuals with type 1 diabetes, hybrid closed-loop (HCL) insulin pump therapy significantly increased the average time in the target glucose range by 18.2% when comparing auto mode to manual mode, indicating improved glucose control.

The use of HCL also led to a 26.7% reduction in time spent in the hyperglycemic range without increasing the time in the hypoglycemic range, suggesting that HCL therapy is both effective and safe for managing blood sugar levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Efficacy of the Hybrid Closed-Loop System. Usoh, CO., Johnson, CP., Speiser, JL., et al.[2022]

Clinicians recognize that hybrid closed loop (HCL) insulin pumps provide significant glycemic benefits for diabetes management, but they believe these systems may not be suitable for all patients, particularly those with cognitive impairments.

The initiation of HCL pump therapy requires a collaborative approach among healthcare professionals to ensure successful patient outcomes, and clinicians reported increased confidence in managing diabetes when using these systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinician Experiences With Hybrid Closed Loop Insulin Delivery Systems in Veterans With Type 1 Diabetes: Qualitative Study. Mizokami-Stout, K., Thompson, HM., Hurren, K., et al.[2023]

This study is a 6-month, multicenter, randomized controlled trial involving young people aged 12 to under 25 with type 1 diabetes, testing the MiniMed Medtronic 670G hybrid closed-loop system against standard therapy.

The primary goal is to measure how much time participants spend in the target glucose range (3.9-10.0 mmol/L) while using the hybrid closed-loop system, which could demonstrate its efficacy in improving glycemic control compared to traditional treatment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of 6 months hybrid closed-loop insulin delivery in young people with type 1 diabetes: a randomised controlled trial protocol. de Bock, M., McAuley, SA., Abraham, MB., et al.[2019]

Closed-loop insulin delivery systems, also known as hybrid closed-loop (HCL) systems, integrate continuous glucose monitoring (CGM) with insulin pumps to automate insulin delivery, significantly improving glycemic control and reducing complications for people with type 1 diabetes.

Advanced Hybrid Closed-Loop (AHCL) systems, which include features like individualized algorithms and automated correction boluses, represent a revolutionary advancement in diabetes management, with several systems currently available or in clinical trials, enhancing patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commercial hybrid closed-loop systems available for a patient with type 1 diabetes in 2022. Seget, S., Tekielak, A., Rusak, E., et al.[2023]

A quality improvement project developed a comprehensive education program for 72 pediatric patients with type 1 diabetes to optimize their use of hybrid closed loop (HCL) therapy, which included in-person classes, live video sessions, and follow-up calls.

The program successfully helped patients maintain their time in HCL therapy during the initial weeks, highlighting the importance of ongoing educational support and potentially setting a standard for implementing new diabetes technologies in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Clinical Training Program for Hybrid Closed Loop Therapy in a Pediatric Diabetes Clinic. Berget, C., Thomas, SE., Messer, LH., et al.[2021]

Citations

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Introduction: This study evaluates the effectiveness of four commercially available automated insulin delivery (AID) systems in routine clinical ...

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pmc.ncbi.nlm.nih.gov/articles/PMC11081057/

Efficacy of the hybrid closed-loop insulin delivery system in ...

In this meta-analysis, HCL compared with control therapies was associated with improved time in range and HbA1c control in children and adolescents with T1D.

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diabetesjournals.org

diabetesjournals.org/care/article/46/11/1916/153534/Fully-Closed-Loop-Glucose-Control-Compared-With

Fully Closed-Loop Glucose Control Compared With Insulin ...

Our findings demonstrate that the CamAPS HX fully closed-loop system significantly improved glycemic control as measured by time in target ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10999042/

Evaluation of hybrid closed-loop insulin delivery system in ...

In this independent study, we evaluated glycemic parameters and PROs over one year of continuous use of Medtronic's 670G HCL in real-world clinical practice.

8.

nature.com

nature.com/articles/s41598-023-40423-y

Efficacy and safety of closed-loop control system for type ...

CLC insulin delivery exhibits significantly better day and night efficacy and safety than SAP therapy in adolescents with type 1 diabetes.

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onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1002/dmrr.3842

Efficacy and Safety of Different Hybrid Closed Loop ...

The results of our analysis confirm that HCL users achieve higher TIR values than individuals on other types of subcutaneous intensive insulin ...