Insulin Pump System for Type 1 Diabetes (STAR-T1D Trial)

N/A

Recruiting

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new technology for managing Type 1 Diabetes in a diverse group of patients with poorly controlled diabetes in Los Angeles. The goal is to see if this technology can help improve diabetes

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include skin irritation at the infusion site, hypoglycemia (low blood sugar), hyperglycemia (high blood sugar), and possible device-related issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants who adhere to assigned treatment

Proportion of average time delay to enrollment

Proportion of enrolled participants that are randomized

+3 more

Secondary study objectives

Change in A1c

ED visits/Hospitalizations Number of diabetes related ED visits or hospitalizations

Episodes and % of time with severe hypoglycemia ( BG <54 mg/dl)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Hybrid Closed Loop Insulin Pump SystemExperimental Treatment1 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: ControlActive Control1 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.

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