Control-IQ 1.5 safety follow-up in young children
What this study tests
A completed US observational study followed children aged 2 to under 6 prescribed Control-IQ version 1.5. The primary endpoints are severe hypoglycemia and ketoacidosis rates; no results are posted in ClinicalTrials.gov.
Editorial review: . 16 September review-note archive (earlier notes may not cover later changes).
Registry checked: 2026-09-17. Registry’s own update: 2026-09-01.
Latest dated source in the citation list: 2026-09-01. This is the source’s date, not a new review of every claim.
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?
- Children aged 2 to under 6 at screening with T1D prescribed Control-IQ 1.5 in a t:slim X2 or Mobi pump, living in the US and using compatible insulin and iCGM. A parent or guardian must meet study requirements; additional exclusions apply. 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. This record describes the registered study plan, not demonstrated 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
- Severe hypoglycemia event rate per 100 patient-years during 12 months of Control-IQ use.
- Diabetic ketoacidosis event rate per 100 patient-years during 12 months of Control-IQ use.
The full picture
The registry reports 144 actual participants in this single-arm prospective cohort. The protocol planned 12 months of real-world follow-up, including monthly safety questionnaires. Severe hypoglycemia and diabetic ketoacidosis incidence are primary outcomes; glucose metrics are secondary.1
The study specifically names Control-IQ technology v1.5 in t:slim X2 and Mobi pumps. Its results, when available, should be attributed to that generation and age group rather than automatically transferred to Control-IQ+ or older children and adults.1
The registry lists study start 2025-01-30 (actual), primary completion 2026-08-10 (actual) and study completion 2026-08-10 (actual). These dates retain the registry’s actual or estimated labels; an estimated date is not confirmation that an event occurred.1
References
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ClinicalTrials.gov. NCT06717451. Last update posted 2026-09-01; checked 17 September 2026. https://clinicaltrials.gov/study/NCT06717451 ↩ ↩2 ↩3
Sources
- [1]PS230005 Control-IQ 1.5 Post-Approval Study (NCT06717451) · Trial registry · 2026-09-01 — Current registered protocol, eligibility, endpoints and status checked 17 September 2026; the citation date records the registry update, not a results publication.