Starting Technology in At Risk Type 1 Diabetes Study

Part of paid clinical trials in Santa Monica, California.

Sponsor
University of California, Los Angeles
Study ID
NCT06453928
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hybrid Closed Loop Insulin Pump System — DEVICE
    Patients will be started on an automated insulin delivery system.

Study Details

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.

Key Dates

Start date
Sep 5, 2024
Status verified
Nov 2025
Primary completion
Jan 31, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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.

Primary Outcome Measure

Proportion of screened participants that are eligible [ Time Frame: 6 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
UCLASanta MonicaCalifornia90404
Rebecca Lopez, BA
[email protected]
(310) 882-0033
Erin E Shaw, B.S.
[email protected]
Olive View-UCLA Medical CenterSylmarCalifornia91342
Hugo Torres, MD
[email protected]
747-210-3000
Harbor-UCLA Medical CenterTorranceCalifornia90502
Joyce A Graham
[email protected]
(310) 222-1870

Find similar trials in Santa Monica, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
UCLA· Santa Monica, CAOlive View-UCLA Medical Center· Sylmar, CAHarbor-UCLA Medical Center· Torrance, CA

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