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Diabetes Mellitus, Type 1STAR-T1DNCT06453928

Starting Technology in At Risk Type 1 Diabetes Study

A study testing Hybrid Closed Loop Insulin Pump System in people with Diabetes Mellitus, Type 1, run by University of California, Los Angeles at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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%). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Hybrid Closed Loop Insulin Pump System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesUnited States
Study dates
5 Sep 2024to 1 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 1 Diabetes
  • A1c ≥ 8.0%
  • Not insulin pump user
  • Primary language of English or Spanish
  • Have medical insurance coverage

Who cannot join

  • 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 locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Estelle M Everett, MD, MHS contact

310-267-0625

eeverett@mednet.ucla.edu

United States3 sites, 3 recruiting

  • UCLA

    Santa Monica, California, 90404

    Rebecca Lopez, BA, (310) 882-0033, rebeccalopez@mednet.ucla.edu

    Erin E Shaw, B.S., EEShaw@mednet.ucla.edu

    Recruiting

  • Olive View-UCLA Medical Center

    Sylmar, California, 91342

    Hugo Torres, MD, 747-210-3000, HATorres@mednet.ucla.edu

    Recruiting

  • Harbor-UCLA Medical Center

    Torrance, California, 90502

    Joyce A Graham, (310) 222-1870, jgraham@lundquist.org

    Recruiting

Other trials in United States

About this study

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

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 ≥8.0%) 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.

Being tested
Hybrid Closed Loop Insulin Pump System
Keywords
Continuous Glucose Monitoring, Insulin Pump, Hybrid Closed Loop Systems, Diabetes Technology, Health Disparities
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hybrid Closed Loop Insulin Pump SystemDevice

    Patients will be started on an automated insulin delivery system.

Study groups in NCT06453928
Study groupRoleWhat they receive
Hybrid Closed Loop Insulin Pump SystemExperimentalParticipants 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.
Receives: Device: Hybrid Closed Loop Insulin Pump System
ControlNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. Proportion of enrolled participants that are randomized

    Randomized among enrolled, and receiving allocated intervention among randomized.

    Measured: 6 months

  3. Proportion of average time delay to enrollment

    Average time delay from screening to enrollment.

    Measured: 6 months

  4. Proportion of retention among participants randomized to the Intervention Group

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

    Measured: 6 months

  5. Proportion of retention among participants randomized

    Participants lost to follow-up among those initially randomized.

    Measured: 6 months

  6. Proportion of retention among participants randomized

    Retention rates by participants completing all research assessments among randomized.

    Measured: 6 months

  7. 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.

    Measured: 6 months

Secondary outcomes (8)

  1. Change in A1c

    Serum Hemoglobin A1c laboratory measurement

    Measured: 6 months

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

    Hypoglycemia will be measure by combining CGM metrics and glucometer to report severe hypoglycemia in mg/dl.

    Measured: 6 months

  3. Mean Diabetes Ketoacidosis Episodes Incidence

    Assess instances of diabetic ketoacidosis through participant surveys and comprehensive chart reviews.

    Measured: 6 months

  4. ED visits/Hospitalizations Number of diabetes related ED visits or hospitalizations

    Number of diabetes related ED visits or hospitalizations

    Measured: 6 months

  5. Treatment Burden and Satisfaction: Diabetes Distress

    Assessing treatment burden through the Type 1 Diabetes Distress Assessment System T1DDAS, which comprises eight questions and evaluates ten prevalent sources of diabetes distress in adults with type 1 diabetes. The score indicates the level of diabetes distress reported by the respondent, with higher scores indicating greater intensity. The core scale scoring ranges 1 to 5. This scale assesses each of ten common Sources of diabetes distress for adults with type 1 diabetes: Financial Worries, Interpersonal Challenges, Management Difficulties, Shame, Hypoglycemia Concerns, Healthcare Quality, Lack Of Diabetes Resources, Technology Challenges, Burden To Others, Worries About Complications. The higher the score, the more impactful that Source is likely to be in contributing to diabetes distress for this individual with the minimum value being 1 and maximum value being 5.

    Measured: 6 months

  6. Treatment Burden and Satisfaction: Insulin Treatment Satisfaction

    Assessed treatment burden and satisfaction using the Insulin Treatment Satisfaction Questionnaire (ITSQ), consisting of 22 questions among 5 content clusters with a score from 0 to 100% where a higher score indicates greater satisfaction with insulin treatment. The scale explores perceptions of current insulin treatment and its impact on daily life.

    Measured: 6 months

  7. Treatment Burden and Satisfaction: Glucose Monitoring System Satisfaction (GMSS)

    Examined treatment burden and satisfaction employing the Glucose Monitoring System Satisfaction Survey (GMSS), comprising 15 questions divided into four subcategories: openness, emotional burden, behavioral burden and trust. Higher scores within each subcategory denote either greater satisfaction or burden, depending on the specific aspect assessed with the minimum value being 1 and maximum value being 5. The total scare has a minimum value of 1 and maximum value of 15 with higher scores indicating greater satisfaction. The scores are obtained by calculating the mean for each.

    Measured: 6 months

  8. Treatment Burden and Satisfaction: Motivation and Attitudes Towards Changing Health (MATCH)

    Assessed treatment burden and satisfaction using the Motivation and Attitudes towards Health Scale (MATCH), consisting of nine questions categorized into four subgroups: willingness to make changes, perceived ability to make or maintain changes, feeling changes are worthwhile, and overall mean/average of willingness, able, and worthwhile. Scores are calculated by determining the mean or average response within each category with higher scores meaning a better outcome.

    WILLINGNESS: minimum value is 1 and maximum value is 5. ABLE: minimum value is 1 and maximum value is 5. WORTHWHILE: minimum value is 1 and maximum value is 5. TOTAL SCALE: minimum value is 1 and maximum value is 9.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2024
  2. Study start5 Sep 2024
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06453928
Sponsor's protocol ID
22-000236
Other IDs
5K23DK132482-02
Acronym
STAR-T1D
Status last verified
Nov 2025
First submitted
26 Apr 2024
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Hybrid Closed Loop Insulin Pump System in people with Diabetes Mellitus, Type 1, run by University of California, Los Angeles at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Estelle M Everett, MD, MHS (310-267-0625, eeverett@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of screened participants that are eligible (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06453928.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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