Starting Technology in At Risk Type 1 Diabetes Study

NCT06453928 | Recruiting DMC FDA Device

• 2 other identifiers: 22-0002365K23DK132482-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (7)

• Proportion of screened participants that are eligible

  Eligible among screened, enrolled among eligible, excluded among screened (and why) based on screening, recruitment and enrollment data.

  6 months

• Proportion of enrolled participants that are randomized

  Randomized among enrolled, and receiving allocated intervention among randomized.

  6 months

• Proportion of average time delay to enrollment

  Average time delay from screening to enrollment.

  6 months

• Proportion of retention among participants randomized to the Intervention Group

  Retention among participants receiving allocated intervention after being randomized and discontinued intervention among randomized.

  6 months

• Proportion of retention among participants randomized

  Participants lost to follow-up among those initially randomized.

  6 months

• Proportion of retention among participants randomized

  Retention rates by participants completing all research assessments among randomized.

  6 months

• Number of participants who adhere to assigned treatment

  Treatment-specific adherence, Adherence to study protocol and Proportion of planned assessments that are completed. Fidelity, which pertains to guaranteeing that the intervention is delivered in accordance with the established protocol, will be summarized by study arms, and differences between arms will be examined using t-tests or two-sample tests of proportions as appropriate. Adherence, which relates to the extent to which participants follow the treatment and study protocol, as well as the proportion of planned assessments completed, will be summarized by study arms, and differences between arms will be examined using t-tests or two-sample tests of proportions as appropriate.

  6 months

Secondary Outcomes (8)

• Change in A1c

  6 months

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

  6 months

• Mean Diabetes Ketoacidosis Episodes Incidence

  6 months

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

  6 months

• Treatment Burden and Satisfaction: Diabetes Distress

  6 months

Study Arms (2)

Hybrid Closed Loop Insulin Pump System

EXPERIMENTAL

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.

Device: Hybrid Closed Loop Insulin Pump System

Control

NO 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.

Interventions

Hybrid Closed Loop Insulin Pump System DEVICE

Patients will be started on an automated insulin delivery system.

Hybrid Closed Loop Insulin Pump System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Olive View-UCLA Education & Research Institute: collaborator
• University of California, Los Angeles: lead

Study Sites (3)

UCLA

Santa Monica, California, 90404, United States

RECRUITING

Olive View-UCLA Medical Center

Sylmar, California, 91342, United States

RECRUITING

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Estelle M Everett, MD, MHS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized controlled trial.

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: June 12, 2024
• Study Start: September 5, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)