# Recent NEJM publication on closed-loop CGM/pump system - probably getting near FDA approval now

**URL:** <https://forum.fudiabetes.org/t/recent-nejm-publication-on-closed-loop-cgm-pump-system-probably-getting-near-fda-approval-now/8514>\
**Category:** T1 Research\
**Tags:** cgm, dexcom, type-1\
**Created:** [October 17, 2019, 3:18pm UTC](https://forum.fudiabetes.org/t/recent-nejm-publication-on-closed-loop-cgm-pump-system-probably-getting-near-fda-approval-now/8514 "2019-10-17T15:18:01Z")\
**Posts on this page:** 1\
**Page:** 1

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**Author:** ![bwschulz](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/bwschulz/32/8869_2.png) [@bwschulz](https://forum.fudiabetes.org/u/bwschulz)\
**Post date:** [October 17, 2019, 3:18pm UTC](https://forum.fudiabetes.org/t/recent-nejm-publication-on-closed-loop-cgm-pump-system-probably-getting-near-fda-approval-now/8514/1 "2019-10-17T15:18:01Z")

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Dexcom/Tandem Control-IQ system (sensor-augmented pump and CGM combination) multi-site RCT comparing automatic vs. manual insulin delivery found 2.6 hours per day more (or 10% more) time in range and fewer highs and lows. These data have already been submitted to FDA for approval of this system.

Summary article here- [https://www.fiercebiotech.com/medtech/closed-loop-artificial-pancreas-from-tandem-dexcom-aces-type-1-diabetes-study](https://www.fiercebiotech.com/medtech/closed-loop-artificial-pancreas-from-tandem-dexcom-aces-type-1-diabetes-study)  
NEJM abstract- [https://www.nejm.org/doi/full/10.1056/NEJMoa1907863](https://www.nejm.org/doi/full/10.1056/NEJMoa1907863)  
Full article behind paywall- sorry!