Clinical trial NCT06453928: Starting Technology in At Risk Type 1 Diabetes Study
Official title: Starting Technology in At Risk Type 1 Diabetes (STAR-T1D) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Continuous Glucose Monitoring
Insulin Pump
Hybrid Closed Loop Systems
Diabetes Technology
Health Disparities
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-06-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of screened participants that are eligible
timeFrame: 6 months
measure: Proportion of enrolled participants that are randomized
timeFrame: 6 months
measure: Proportion of average time delay to enrollment
timeFrame: 6 months
measure: Proportion of retention among participants randomized to the Intervention Group
timeFrame: 6 months
measure: Proportion of retention among participants randomized
timeFrame: 6 months
measure: Proportion of retention among participants randomized
timeFrame: 6 months
measure: Number of participants who adhere to assigned treatment
timeFrame: 6 months
Secondary outcomes:
measure: Change in A1c
timeFrame: 6 months
measure: Episodes and % of time with severe hypoglycemia ( BG <54 mg/dl)
timeFrame: 6 months
measure: Mean Diabetes Ketoacidosis Episodes Incidence
timeFrame: 6 months
measure: ED visits/Hospitalizations Number of diabetes related ED visits or hospitalizations
timeFrame: 6 months
measure: Treatment Burden and Satisfaction: Diabetes Distress
timeFrame: 6 months
measure: Treatment Burden and Satisfaction: Insulin Treatment Satisfaction
timeFrame: 6 months
measure: Treatment Burden and Satisfaction: Glucose Monitoring System Satisfaction (GMSS)
timeFrame: 6 months
measure: Treatment Burden and Satisfaction: Motivation and Attitudes Towards Changing Health (MATCH)
timeFrame: 6 months
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: UCLA
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
Study officials:
References: