Recruiting

At Risk Type 1 Diabetes

Sponsor:

UCLA

Code:

NCT06453928

Conditions

Diabetes Mellitus, Type 1

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hybrid Closed Loop Insulin Pump System

Study Details

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 ID

NCT06453928

Start date

Sep 5, 2024

Status verified date

Nov, 2025

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: 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.

Interventions

Hybrid Closed Loop Insulin Pump System

Patients will be started on an automated insulin delivery system.

Primary outcome measure

  • Proportion of screened participants that are eligible [ Time Frame: 6 months ]
  • Proportion of enrolled participants that are randomized [ Time Frame: 6 months ]
  • Proportion of average time delay to enrollment [ Time Frame: 6 months ]
  • Proportion of retention among participants randomized to the Intervention Group [ Time Frame: 6 months ]
  • Proportion of retention among participants randomized [ Time Frame: 6 months ]
  • Proportion of retention among participants randomized [ Time Frame: 6 months ]
  • Number of participants who adhere to assigned treatment [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Estelle M Everett, MD, MHS

310-267-0625eeverett@mednet.ucla.edu

Locations

UCLA

Recruiting

Santa Monica, California, United States, 90404

Contacts

Rebecca Lopez, BA

(310) 882-0033rebeccalopez@mednet.ucla.edu

Erin E Shaw, B.S.

EEShaw@mednet.ucla.edu

Olive View-UCLA Medical Center

Recruiting

Sylmar, California, United States, 91342

Contacts

Hugo Torres, MD

747-210-3000HATorres@mednet.ucla.edu

Harbor-UCLA Medical Center

Recruiting

Torrance, California, United States, 90502

Contacts

Joyce A Graham

(310) 222-1870jgraham@lundquist.org

More Information

Sponsor

University of California, Los Angeles

Last update posted

Feb 13, 2026

Last verified

Nov, 2025

Keywords

  • Continuous Glucose Monitoring
  • Insulin Pump
  • Hybrid Closed Loop Systems
  • Diabetes Technology
  • Health Disparities

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-02-13.