Insulin Pump System for Type 1 Diabetes

(STAR-T1D Trial)

Recruiting at 1 trial location

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

Trial Summary

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 data supports the effectiveness of the treatment Hybrid Closed Loop Insulin Pump System for Type 1 Diabetes?

Research shows that Hybrid Closed Loop (HCL) systems, which combine insulin pumps with continuous glucose monitoring, help improve blood sugar control and reduce low blood sugar episodes in people with Type 1 Diabetes. These systems have been effective in both children and adults, leading to better overall management of the condition. ^{1 2 3 4 5}

Is the hybrid closed loop insulin pump system safe for humans?

Hybrid closed loop insulin pump systems have been shown to be safe for people with type 1 diabetes, with no episodes of severe low blood sugar or ketoacidosis (a serious diabetes complication) reported in studies. These systems are used both in outpatient and inpatient settings, and they help manage blood sugar levels effectively. ^{1 3 5 6 7}

How is the Hybrid Closed Loop Insulin Pump System treatment different from other treatments for type 1 diabetes?

The Hybrid Closed Loop Insulin Pump System is unique because it combines continuous glucose monitoring with an insulin pump that automatically adjusts insulin delivery using a smart algorithm, reducing the need for constant manual adjustments and improving blood sugar control. ^{1 3 6 8 9}

What is the purpose of this trial?

Diabetes technology has revolutionized T1D management, disparities in technology access are evident among racial-ethnic minorities, patients with lower socioeconomic status and those with poorly controlled T1D (A1c\>8.5%). In order to examine whether diabetes technology can reduce diabetes care burdens and enhance outcomes among some of highest need patients, diabetes technology clinical trials must be expanded beyond the very select populations included in studies thus far (ie., mostly White, higher SES). Therefore, the investigators propose to perform a pilot RCT of hybrid closed-loop insulin pump therapy (HCL) in 40 diverse adult patients with poorly controlled T1D (HbA1c \>8.5%) from the largest academic and safety net health systems in the Los Angeles region to determine the feasibility of a RCT in this population and identify facilitators and barriers of effective use of closed loop insulin pump therapy in patients with poorly controlled T1D.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. England 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. [2023]

2. England 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. [2019]

3. Canada pubmed.ncbi.nlm.nih.gov

Clinician Experiences With Hybrid Closed Loop Insulin Delivery Systems in Veterans With Type 1 Diabetes: Qualitative Study. [2023]

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

Real-World Efficacy of the Hybrid Closed-Loop System. [2022]

5. Germany 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. [2023]

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

Hybrid Closed-Loop Insulin Pump Technology Can Be Safely Used in the Inpatient Setting. [2023]

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

Glucose Control Using a Standard Versus an Enhanced Hybrid Closed Loop System: A Randomized Crossover Study. [2022]

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

A Clinical Training Program for Hybrid Closed Loop Therapy in a Pediatric Diabetes Clinic. [2021]

9. Poland pubmed.ncbi.nlm.nih.gov

Commercial hybrid closed-loop systems available for a patient with type 1 diabetes in 2022. [2023]