Starting Technology in At Risk Type 1 Diabetes Study

Diabetes Mellitus, Type 1 Clinical Trial

— STAR-T1D  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06453928
• Other study ID #: 22-000236
• Secondary ID: 5K23DK132482-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: May 2027

Study information

• Verified date: June 2024
• Source: University of California, Los Angeles
• Contact: Estelle M Everett, MD, MHS
• Phone: 310-267-0625
• Email: eeverett[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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>9%). 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 >9%) 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 2027
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Not insulin pump user

• Primary language of English or Spanish

• Have medical insurance coverage

Exclusion Criteria:

• Not seen by endocrinology at least once in the past 12 months

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Los Angeles	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Proportion of enrolled participants that are randomized	Randomized among enrolled, and receiving allocated intervention among randomized.	6 months
Primary	Proportion of average time delay to enrollment	Average time delay from screening to enrollment.	6 months
Primary	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
Primary	Proportion of retention among participants randomized	Participants lost to follow-up among those initially randomized.	6 months
Primary	Proportion of retention among participants randomized	Retention rates by participants completing all research assessments among randomized.	6 months
Primary	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	Change in A1c	Serum Hemoglobin A1c laboratory measurement	6 months
Secondary	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
Secondary	Mean Diabetes Ketoacidosis Episodes Incidence	Assess instances of diabetic ketoacidosis through participant surveys and comprehensive chart reviews.	6 months
Secondary	ED visits/Hospitalizations Number of diabetes related ED visits or hospitalizations	Number of diabetes related ED visits or hospitalizations	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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