Starting Technology in At Risk Type 1 Diabetes Study (STAR-T1D)

University of California, Los Angeles (UCLA)

Status: Enrolling

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: Hybrid Closed Loop Insulin Pump System

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06453928

22-000236

5K23DK132482-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 Diabetes
• A1c >8.5%
• Not insulin pump user
• Primary language of English or Spanish
• Have medical insurance coverage

Exclusion criteria

• No measured A1c in the past year
• Have comorbidities that can result in inaccurate hemoglobin A1c
• Have cognitive, physical or mental impairment precluding diabetes technology use
• Limited life expectancy (<1 year)
• Pregnancy

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Hybrid Closed Loop Insulin Pump System

Experimental group

Description:

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.

Treatment:

Device: Hybrid Closed Loop Insulin Pump System

Control

No Intervention group

Description:

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.