FDA approves only triple-combination tablet with Empagliflozin

      The U.S. Food and Drug Administration has approved Trijardy™ XR (empagliflozin / linagliptin / metformin hydrochloride extended release tablets) to lower blood sugar in adults with type 2 diabetes, along with diet and exercise. The FDA approval of Trijardy XR is based on two randomized open-label trials that assessed the bioequivalence of empagliflozin, linagliptin and metformin hydrochloride extended release fixed-dose combination tablets and their individual components in healthy adults. The safety profile of Trijardy XR was found to be consistent with its individual components.

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Tandem t:slim X2 may be safe in toddlers and preschoolers with type 1 diabetes

      Glycemic control is a major challenge in people with type 1 diabetes, especially in children. According to a study published in Diabetes Technology & Therapeutics, a modified version of an FDA-approved close-loop insulin delivery system may be effective for children aged 2 to 5 years with type 1 diabetes.

      This FDA approved clinical study utilized a modified, investigational version of Control-IQ (Control-IQ Pro), which removed the weight variable and lowered the total daily insulin lower limit to 5 U/day. Study was conducted in type 1 diabetes participants who were 2 to 5 years old at the time of the study, were current users of an insulin pump and Dexcom CGM, and had a total daily insulin dose of at least 5 U during 48 h in an outpatient supervised hotel (SH) setting followed by 3 days of home use to examine the safety of this system in young children. Parents were trained on the study devices (Tandem t:slim X2™ insulin pump with Control-IQ™ and a Dexcom G6® CGM) by a qualified trainer.

      The pilot study results show that with the use of Control-IQ, the percentage of participants meeting the prespecified goals of less than 6% time below 70 mg/dL and less than 40% time above 180 mg/dL had increased from 33% to 83%. Control-IQ uses significantly improved percent time in range (70–180 mg/dL) compared to baseline and therefore the use of the modified Control-IQ system was safe in 2–5-year-old children with T1D and was found to improve glycemic control as well.

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