Control-IQ with Lyumjev: experimental settings pilot
What this study tests
A completed randomized US pilot enrolled 11 participants aged 12–22. It compared Control-IQ using Lyumjev with experimental settings against Humalog or Novolog with optimized settings during a two-week randomized period. No results are posted.
Editorial review: . 16 September review-note archive (earlier notes may not cover later changes).
Registry checked: 2026-09-17. Registry’s own update: 2026-09-08.
Most recent recorded citation date: 2026-09-08. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. Review coverage and open work · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Ages 12–22, T1D for at least one year, insulin use for at least six months, and Tandem t:slim with Control-IQ use for at least two months. Participants had to meet insulin-use and HbA1c requirements and follow the study protocol. Exclusions include DKA or severe hypoglycemia with seizure or loss of consciousness within six months, pregnancy and non-insulin glucose-lowering drugs. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- No results are posted in ClinicalTrials.gov as of 17 September 2026. Registered endpoints and procedures are study plans, not evidence of benefit or safety.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: United States. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the 16 September review-note archive and current review coverage. Later changes and new records may not appear in the earlier notes. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- Between-group difference in CGM time in 70–180 mg/dL (3.9–10.0 mmol/L) during 14 days, adjusted for baseline time in range.
The full picture
The registry describes an open-label, randomized, parallel-group trial with 11 actual participants and a site in Virginia, United States. Its title refers to adolescents, but eligibility explicitly spans ages 12–22, including young adults. Actual total enrollment is not an analyzed or arm-specific denominator.1
All participants first underwent clinician-led optimization with Humalog or Novolog and a two-week baseline assessment. The planned randomized period then compared two weeks of Lyumjev with an experimental settings conversion against continued Humalog or Novolog with optimized settings. This is a research protocol, not a dosing or settings recommendation.1
The registry lists actual start on 23 July 2025, actual primary completion on 27 February 2026 and actual study completion on 10 March 2026. The last update was posted on 8 September 2026. No results are posted, so completion does not demonstrate improved time in range or safety.1
The inclusion list gives an HbA1c lower boundary above 6.5%, whereas the exclusion list only excludes values below 6.5%; the treatment of exactly 6.5% is unclear in the registry. Both lists use an upper limit of 12%. The detailed protocol and investigators determine eligibility; the condensed highlights here are not a complete screening tool.1
References
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ClinicalTrials.gov. NCT06948760. Last update posted 2026-09-08; checked 17 September 2026. https://clinicaltrials.gov/study/NCT06948760 ↩ ↩2 ↩3 ↩4
Sources
- [1]Testing a Conversion Factor for a More Rapidly Acting Insulin in an Automated Insulin Delivery System Among Adolescents With T1D · Trial registry · 2026-09-08 — Original registry protocol, eligibility, outcomes and status checked 17 September 2026. Citation date is the last posted registry update, not a results publication.