Starting Technology in At Risk Type 1 Diabetes Study

NCT ID: NCT06453928

Last Updated: 2026-02-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-05
• Study Completion Date: 2027-06-01

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Hybrid Closed Loop Insulin Pump System

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 Type: EXPERIMENTAL

Hybrid Closed Loop Insulin Pump System

Intervention Type: DEVICE

Patients will be started on an automated insulin delivery system.

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hybrid Closed Loop Insulin Pump System

Patients will be started on an automated insulin delivery system.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

OTHER

Sponsor Role: collaborator

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

NIH

Sponsor Role: collaborator

Olive View-UCLA Education & Research Institute

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Estelle M. Everett, MD, MHS

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UCLA

Santa Monica, California, United States

Site Status: RECRUITING

Olive View-UCLA Medical Center

Sylmar, California, United States

Site Status: RECRUITING

Harbor-UCLA Medical Center

Torrance, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Estelle M Everett, MD, MHS

Role: CONTACT

eeverett@mednet.ucla.edu

310-267-0625

Facility Contacts

Rebecca Lopez, BA

Role: primary

rebeccalopez@mednet.ucla.edu

(310) 882-0033

Erin E Shaw, B.S.

Role: backup

EEShaw@mednet.ucla.edu

Hugo Torres, MD

Role: primary

HATorres@mednet.ucla.edu

747-210-3000

Joyce A Graham

Role: primary

jgraham@lundquist.org

(310) 222-1870

Other Identifiers

5K23DK132482-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-000236

Identifier Type: -

Identifier Source: org_study_id