Tandem Control-IQ Pivotal Trial Problem
Tandem Diabetes Care announced that it is using the Tandem Device Updater to “resolve a Control-IQ technology software anomaly identified during the ongoing DCLP3 phase of the International Diabetes Closed Loop (IDCL) clinical trial.” According to the press release, Tandem is in discussion with the IDCL study investigators to evaluate any impact on the clinical or regulatory strategy. Recall, Tandem had been planning to launch Control-IQ as early as Summer 2019. Below, FENIX provides insight on the potential impact to the initial Control-IQ regulatory approval as well as thoughts on how Tandem has already started to spin the news as a positive indicator.
About The Author
Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.
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