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<blockquote data-quote="tim2000s" data-source="post: 1926089" data-attributes="member: 30007"><p>The interesting thing about the "very tight" criteria is that they talk about an Hba1C of more than 8.5% being applicable and testing more than eight times per day. </p><p></p><p>In the last NDA, the number of people with Hba1C of more than 7.5% was something like 75%, and more than 8.5% was more than 25% (I think it was around 35%-40%). On this metric alone, it means that more than 25% of people qualify.</p><p></p><p>Secondly, to achieve Hba1C values of less than 7.5% (as 30% of the NDA covered T1s did) usually requires the use of Libre, CGM or testing more than 8x per day. So I think this is another area where you'll find a lot of people qualify. I think the 25% number was used to not scare CCGs. I think the reality will be much nearer 65%.</p></blockquote><p></p>
[QUOTE="tim2000s, post: 1926089, member: 30007"] The interesting thing about the "very tight" criteria is that they talk about an Hba1C of more than 8.5% being applicable and testing more than eight times per day. In the last NDA, the number of people with Hba1C of more than 7.5% was something like 75%, and more than 8.5% was more than 25% (I think it was around 35%-40%). On this metric alone, it means that more than 25% of people qualify. Secondly, to achieve Hba1C values of less than 7.5% (as 30% of the NDA covered T1s did) usually requires the use of Libre, CGM or testing more than 8x per day. So I think this is another area where you'll find a lot of people qualify. I think the 25% number was used to not scare CCGs. I think the reality will be much nearer 65%. [/QUOTE]
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