Starting Technology in At Risk Type 1 Diabetes Study
ConditionDiabetes Mellitus, Type 1
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Los Angeles
About this trial
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
This trial does not accept healthy volunteersQualifiers
Type 1 Diabetes
A1c ≥ 8.0%
Not insulin pump user
Primary language of English or Spanish
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Hybrid Closed Loop Insulin Pump System
DevicePatients will be started on an automated insulin delivery system.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Hybrid Closed Loop Insulin Pump SystemExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
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.
Time frame
6 months2
Proportion of enrolled participants that are randomized
Randomized among enrolled, and receiving allocated intervention among randomized.
Time frame
6 months3
Proportion of average time delay to enrollment
Average time delay from screening to enrollment.
Time frame
6 months4
Proportion of retention among participants randomized to the Intervention Group
Retention among participants receiving allocated intervention after being randomized and discontinued intervention among randomized.
Time frame
6 monthsSecondary outcomes
1
Change in A1c
Serum Hemoglobin A1c laboratory measurement
Time frame
6 months2
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.
Time frame
6 months3
Mean Diabetes Ketoacidosis Episodes Incidence
Assess instances of diabetic ketoacidosis through participant surveys and comprehensive chart reviews.
Time frame
6 months4
ED visits/Hospitalizations Number of diabetes related ED visits or hospitalizations
Number of diabetes related ED visits or hospitalizations
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Los Angeles
Lead sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Olive View-UCLA Education & Research Institute
Collaborator
Source ClinicalTrials.gov