An interventional study of Hybrid Closed Loop Insulin Pump System in Diabetes Mellitus, Type 1, sponsored by University of California, Los Angeles. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Health services research
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Among 1,458 studies in Diabetes Mellitus, Type 1 with a site in United States — 191 open to participants now, 259 under way, 17 of them phase 3. Diabetes Mellitus, Type 1 · United States.
Among the 1,458 studies in Diabetes Mellitus, Type 1 with a site in United States, this one is the 614th largest by planned enrollment of the 1,242 interventional ones that give a count, is one of 63 that started in 2024, is one of 614 with no phase, reaches primary completion later than 87 of the 258 other live ones, and was the 1,299th registered.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
Browse Diabetes Mellitus, Type 1 studies →191 of the 1,458 studies in Diabetes Mellitus, Type 1 with a site in United States are open now. Recruiting first, the newest first:
Emory University · Sites in United States
Ages 31–75 · Healthy volunteers
University of California, Los Angeles · Sites in United States
Ages 18+
Wayne State University · Sites in United States
Ages 16–20
Medtronic MiniMed, Inc. · Sites in United States
Ages 2–80
University of Colorado, Denver · Sites in United States
Ages 10–20
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 412 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 258 (63%) stop at 75 or younger; 185 take children under 18; 64 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,458 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 206 · Phase 2 267 · Phase 3 167 · Phase 4 74
First in 1983; this study’s year is marked. 63 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40 is close to the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Median enrollment 40 across the 1,242 interventional studies, 64 across the 203 observational. Of the 1,117 that completed or were terminated, 563 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
398 of 1,458 have an industry lead sponsor. The 10 most frequent:
University of California, Los Angeles is the lead sponsor of 1,170 studies on the registry; 195 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 70 (74%) have results posted.
University of California, Los Angeles has 3 studies filed under Diabetes Mellitus, Type 1 — fewer than ten, so there is no comparison to draw.
117 of the studies in Diabetes Mellitus, Type 1 with a site in United States that are under way reach primary completion within a year, 7 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06914895Phase 3Eli Lilly and CompanyA Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT06962280Phase 3Eli Lilly and CompanyA Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT07076199Phase 3Novo Nordisk A/SA Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes | 2027-01-25 |
| NCT06334133Phase 3vTv TherapeuticsCadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes | 2027-04 |
| NCT07056699Phase 3The University of Texas Health Science Center at San AntonioSGLT2i, Pioglitazone, and Ketone Production in T1D | 2027-06-01 |
Add all 117 to your calendar (.ics) → With an account.
Among the 1,458 studies in Diabetes Mellitus, Type 1 with a site in United States, from their registry updates:
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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 ≥8.0%) 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.
The criteria were revised on the registry on Sep 25, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Patients will be started on an automated insulin delivery system.
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 months
Proportion of enrolled participants that are randomized
Randomized among enrolled, and receiving allocated intervention among randomized.
Time frame: 6 months
Proportion of average time delay to enrollment
Average time delay from screening to enrollment.
Time frame: 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.
Time frame: 6 months
Proportion of retention among participants randomized
Participants lost to follow-up among those initially randomized.
Time frame: 6 months
Proportion of retention among participants randomized
Retention rates by participants completing all research assessments among randomized.
Time frame: 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.
Time frame: 6 months
Change in A1c
Serum Hemoglobin A1c laboratory measurement
Time frame: 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.
Time frame: 6 months
Mean Diabetes Ketoacidosis Episodes Incidence
Assess instances of diabetic ketoacidosis through participant surveys and comprehensive chart reviews.
Time frame: 6 months
ED visits/Hospitalizations Number of diabetes related ED visits or hospitalizations
Number of diabetes related ED visits or hospitalizations
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2024 (actual). Primary completion is estimated for Jan 2027, 28 months after the start.
Of 845 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 28 months is above that.
Counting every sponsor, half of 950 studies reached it within 18 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University of California, Los Angeles →