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TNDM

18:57
06/09/19
06/09
18:57
06/09/19
18:57

Tandem reports results from studies of t:slim X2 insulin pump with Control-IQ

Tandem Diabetes announced results from two studies of the t:slim X2 insulin pump with Control-IQ advanced hybrid closed-loop technology. Data from both studies demonstrated that the system achieved the primary outcome of increasing time in range without any severe hypoglycemic events. The t:slim X2 insulin pump with Control-IQ technology utilizes Dexcom G6 continuous glucose monitoring sensor values to predict glucose levels and adjust insulin delivery to prevent highs and lows, while still allowing the user to manually bolus for meals. The system also automates correction boluses, which is a feature not commercially available today on automated insulin delivery devices. Details from the two studies, which included Protocol 3 of the National Institutes of Health-funded International Diabetes Closed Loop trial and interim data from the Freelife Kid AP study, were presented at the 79th Scientific Sessions of the American Diabetes Association. The NIH-funded DCLP3 study is the first large-scale, 6-month closed-loop study that included a dedicated control group, increasing the clinical significance of the study results. There were no exclusion criteria based on hemoglobin A1c, history of acute complications, or previous experience using an insulin pump or CGM. Following a two to eight-week run-in period, the length of which was determined based on previous pump and CGM experience, 168 patients with type 1 diabetes ages 14 and up were randomized 2:1 to Control-IQ technology or sensor-augmented pump therapy and followed for 26 weeks. The entry HbA1c for participants in the study ranged from 5.4 to 10.6 with a mean of 7.4%. Approximately 20% of participants were new to pump therapy and the large majority were already using a CGM. All participants completed the study. The Freelife Kid AP study is a multi-center, randomized assessment of the efficacy of closed-loop insulin therapy in prepubertal children, comparing nocturnal and 24-hour use of Control-IQ technology over 18 weeks, followed by an 18-week extension. The completed study, taking place in France, is expected to include 120 participants with type 1 diabetes ages 6 to 12 years old. An interim analysis was planned after 12 weeks from the first 30 included subjects to assess percent of time in closed-loop mode, incidence of any severe adverse events and efficacy measures based on CGM data. The t:slim X2 insulin pump with Control-IQ technology utilizes Dexcom G6 CGM sensor values to predict glucose levels 30 minutes ahead and adjust insulin delivery to help prevent highs and lows, while still allowing the user to manually bolus for meals. The system also automates correction boluses, which is a feature not commercially available today on automated insulin delivery devices.

  • 26

    Aug

TNDM TNDM

05/01/19
OPCO
05/01/19
NO CHANGE
Target $80
OPCO
Outperform
Tandem Diabetes price target raised to $80 from $68 at Oppenheimer
Oppenheimer analyst Steven Lichtman raised his price target for Tandem Diabetes to $80 from $68 as its Q1 sales of $66M were well above his/Street's expectations, led by strong U.S. pump shipments, and continued international expansion. Heading into 2020, the analyst expects new drivers to build, namely increased pump renewal contribution, Control-IQ launch and t:sport introduction. He reiterates an Outperform rating on the shares.
05/01/19
CHLM
05/01/19
NO CHANGE
Target $84
CHLM
Buy
Tandem Diabetes price target raised to $84 from $70 at Craig-Hallum
Craig-Hallum analyst Alexander Nowak raised his price target for Tandem Diabetes to $84 from $70 as results again surpassed the Street's estimates and the company raised guidance. The analyst reiterates a Buy rating on the shares.
05/13/19
LEER
05/13/19
INITIATION
Target $83
LEER
Outperform
Tandem Diabetes initiated with an Outperform at SVB Leerink
SVB Leerkink analyst Danielle Antalffy initiated Tandem Diabetes with an Outperform and $83 price target.
05/13/19
PIPR
05/13/19
NO CHANGE
Target $78
PIPR
Overweight
Tandem Diabetes' 'rapid' growth can continue, says Piper Jaffray
Piper Jaffray analyst JP McKim reiterates an Overweight rating on Tandem Diabetes with a $78 price target after traveling with management. The company can continue its "rapid" growth though international expansion beyond Animas patients, McKim tells investors in a research note titled "Travel With Management Confirms 'Goldilocks Period' Set To Continue." Further, while Animas supplies stop September 2019, there will be patients who stock up on supplies into 2020 and also some of the patients who took the free MDT 630G in late 2017 will have their old Animas warranty expire and allow them to re-enter the pump market once again, adds the analyst. He also expects Tandem win market share.

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