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Recruiting NCT06453928

Starting Technology in At Risk Type 1 Diabetes Study

No phase Interventional Diabetes Mellitus, Type 1

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hybrid Closed Loop Insulin Pump System.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 1. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Proportion of screened participants that are eligible [Time frame: 6 months]
  • Proportion of enrolled participants that are randomized [Time frame: 6 months]
  • Proportion of average time delay to enrollment [Time frame: 6 months]
  • Proportion of retention among participants randomized to the Intervention Group [Time frame: 6 months]
  • Proportion of retention among participants randomized [Time frame: 6 months]
  • Proportion of retention among participants randomized [Time frame: 6 months]
  • Number of participants who adhere to assigned treatment [Time frame: 6 months]
Secondary outcome measures (8)
  • Change in A1c [Time frame: 6 months]
  • Episodes and % of time with severe hypoglycemia ( BG <54 mg/dl) [Time frame: 6 months]
  • Mean Diabetes Ketoacidosis Episodes Incidence [Time frame: 6 months]
  • ED visits/Hospitalizations Number of diabetes related ED visits or hospitalizations [Time frame: 6 months]
  • Treatment Burden and Satisfaction: Diabetes Distress [Time frame: 6 months]
  • Treatment Burden and Satisfaction: Insulin Treatment Satisfaction [Time frame: 6 months]
  • Treatment Burden and Satisfaction: Glucose Monitoring System Satisfaction (GMSS) [Time frame: 6 months]
  • Treatment Burden and Satisfaction: Motivation and Attitudes Towards Changing Health (MATCH) [Time frame: 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 3 centers
  • UCLA — Santa Monica
  • Olive View-UCLA Medical Center — Sylmar
  • Harbor-UCLA Medical Center — Torrance

Identifiers

NCT: NCT06453928 · 22-000236 · 5K23DK132482-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗