16 September 2026 editorial review · Trial
Control-IQ closed-loop in children 6–13 (DCLP5 pediatric pivotal): review notes
These notes document the scope actually reviewed, including source-access limits. They are not independent clinical certification or a guarantee that every claim was verified.
Read the trial evidence page →Baseline trial evidence review: A–H
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT03844789. Registered endpoint checked: Continuous Glucose Monitor (CGM)-Measured Percent Time in Range 70-180mg/dL Over 16 Week Trial Period (From randomization to data collection completion at the end of 16 weeks). Eligibility check: Registry age 6 Years to 13 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Accessible primary literature: A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes.; Successful At-Home Use of the Tandem Control-IQ Artificial Pancreas System in Young Children During a Randomized Controlled Trial.. Limits: Primary abstract findings were available; supplementary tables and full adverse-event adjudication were not comprehensively re-reviewed. Registry eligibility is not a claim of current site availability.