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

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 >8.5%) 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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Device: Hybrid Closed Loop Insulin Pump System

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Estelle M Everett, MD, MHS; Phone Number: 310-267-0625; Email: eeverett@mednet.ucla.edu

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Recruiting
      • UCLA
      • Contact: Rebecca Lopez, BA; Phone Number: (310) 882-0033; Email: rebeccalopez@mednet.ucla.edu
      • Contact: Erin E Shaw, B.S.; Email: EEShaw@mednet.ucla.edu
    • Sylmar, California, United States, 91342
      • Recruiting
      • Olive View-UCLA Medical Center
      • Contact: Hugo Torres, MD; Phone Number: 747-210-3000; Email: HATorres@mednet.ucla.edu
    • Torrance, California, United States, 90502
      • Recruiting
      • Harbor-UCLA Medical Center
      • Contact: Joyce A Graham; Phone Number: (310) 222-1870; Email: jgraham@lundquist.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Hybrid Closed Loop Insulin Pump System; Patients will be started on an automated insulin delivery system.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in A1c	Serum Hemoglobin A1c laboratory measurement	6 months
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.	6 months
Mean Diabetes Ketoacidosis Episodes Incidence	Assess instances of diabetic ketoacidosis through participant surveys and comprehensive chart reviews.	6 months
ED visits/Hospitalizations Number of diabetes related ED visits or hospitalizations	Number of diabetes related ED visits or hospitalizations	6 months
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.	6 months
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.	6 months
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.	6 months
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.	6 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Continuous Glucose Monitoring; Insulin Pump; Health Disparities; Diabetes Technology; Hybrid Closed Loop Systems
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: 22-000236; 5K23DK132482-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No