Top in endocrinology: FDA letter on teplizumab, CMS policy change on diabetes care
The FDA sent a letter to Provention Bio requesting additional information on teplizumab as a therapy for delaying the development of type 1 diabetes in high-risk children and adults. It was the top story in endocrinology last week.
Another top story was about recent CMS changes for Medicare beneficiaries with diabetes, who can now use continuous glucose monitors (CGMs) when prescribed multiple daily insulin administrations — updated from injections or the use of insulin pump therapy. The policy change also eliminates the four times per day testing requirement to qualify for a CGM device.
Read these and more top stories in endocrinology below:
FDA issues complete response letter for teplizumab
The FDA issued a complete response letter for a biologics license application for teplizumab for the delay of type 1 diabetes in high-risk children and adults, stating a study failed to show pharmacokinetic comparability. Read more.
CMS updates CGM, insulin use criteria for Medicare beneficiaries
CMS will now allow Medicare beneficiaries with diabetes to use any insulin along with continuous glucose monitor therapy and eliminate a four times per day testing requirement, part of a policy change to the local coverage determination. Read more.
Few high-quality studies published on dietary supplements, therapies for weight loss
Most studies on dietary supplements and alternative therapies for weight loss are considered low quality due to small sample size, short follow-up and poor design, according to findings from a systematic review and meta-analysis. Read more.
Smart insulin pen improves glucose levels in poorly controlled diabetes
People with diabetes who have difficulty meeting glycemic targets were better able to manage their glucose levels with a smart insulin pen, according to a speaker at the American Diabetes Association Scientific Sessions. Read more.
Adding CGM data to EHR could boost use in primary care diabetes management
A pilot process that incorporates patients’ continuous glucose monitoring data directly into the electronic health record improved clinician access to valuable glucose information and should be expanded, according to a speaker. Read more.