Diabetes News

Insulet’s Randomized Controlled Trial (OP5-003) Demonstrates Omnipod® 5 Automated Insulin Delivery System is Superior to Pump Therapy

Insulet Announces CE Mark Approval of Omnipod® 5 Integration with Abbott FreeStyle Libre 2 Plus Sensor

Tandem Diabetes Care Launches Tandem Mobi, the World’s Smallest, Durable Automated Insulin Delivery System

Tandem Diabetes Care’s t:slim X2™ Insulin Pump is the First Automated Insulin Delivery System to Integrate with Abbott’s New FreeStyle Libre® 2 Plus Sensor

New real-world data shows MiniMed™ 780G system sustains strong global performance, exceeding international targets for diabetes management

Medtronic Diabetes announces world's first approval for MiniMed™ 780G System with Simplera Sync™ disposable, all-in-one sensor

780G arrives in US with June 1st availability. 7-day infusion set, new sensor and meal detection technology.

G7 cleared by FDA for those age 2 and over. Overall MARD of 8.2%. iCGM designation and aproved for AID systems.

Company acquires privately-held Swiss developer of the Sigi™ Patch Pump, which uses pre-filled insulin cartridges.

FSL3 integrated with mylife Loop solution from Ypsomed in Germany. AID system uses CamAPS algorithm.

Linkages with Dexcom, Tempo BGM (and others), & wearables from Fitbit®, Garmin®, Google Fit® and Apple.

Once-weekly icodec shows superior reduction in HbA1c in combo with a dosing app versus once-daily basal insulin.

G7 Launches in the UK, Ireland, Germany, Austria & Hong Kong – initiating global rollout of company’s newest sensor.

O5 begins full market release into US retail pharmacy channels for T1Ds aged six and older.

T2D HbA1c improvement of 1.3%, 31% reduction in insulin use. Poster on T1D missed meal bolus performance.

SURMOUNT-1 data shows up to 23% weight loss in non-diabetes patients (up to 52 lbs). 63% lost 20% body mass.

Once-weekly insulin icodec showed superior HbA1c reduction vs. degludec (0.93% vs. 0.71%) over 26 weeks.

13 week study of adults and children showed 0.5% HbA1c reduction and 2.6 hours more time-in-range.

Dexcom ONE launching in UK in May. Available for both G6 and G7. Under review by NHS drug tariff.

CE Mark obtained for new sensor featuring smaller footprint, 30-min warm-up, optional receiver, & 8.1% MARD.

Company enters into agreement with Sanofi for commercialization of digital health solutions.

Adults hospitalized for acute heart failure had a 36% clinical benefit after being placed on Jardiance for 90 days.

US FDA approves Jardiance to treat adults with heart failure regardless of left ventricular ejection fraction.

CKD trial stopped early due to clear efficacy for Jardiance. Data will be presented later this year.

FY revenue of $1.1 billion. Q4 growth of 25% (28% growth domestically). Gross margin of 69.3%.

$703 million sales for FY 2021. Q4 growth of 25%. (15% USA). Company guides to 20%+ growth for 2022.

Diabetes revenue of $584 million down 7% (high teens declines in the US, single digit growth internationally).

Beta Bionics raises $57 million for continued development of the iLet (both single and dual-hormone pump)

Tandem Diabetes Care receives approval for its new mobile controller, including iPhone 12 and Samsung.

ICER issues final evidence report for tirzepatide citing clincial benefit but wanting CV data for 1L recommendation.

San Diego-based Modular Medical prices a public offering for the develoment of its innovative patch pump.

Insulet announces the approval of the industry’s newest AID system with phone control and patch design.

Abbott releases earnings showing robust Libre growth with WW installed base nearing 4 million people.

Ozempic continues robust growth and semaglutide combo programs progress through the pipeline.

Tirzepatide expected to launch in 2H of 2022 and robust pipeline has multiple shots on goal for diabetes/obesity.

CMS expands diabetes Medicare coverage to include CGMs that integrate with Medtronic insulin pumps.

FDA issues warning letter following inspection related to recalls of MiniMed 600 and 508 series pumps and remote.

Pivotal trial extension results showed TIR improvment from 64% to 73% after 12 months and A1C decline to 6.8%

Europe’s CHMP recommends label extension for Ozempic 2.0mg based on results of the SUSTAIN FORTE trial.

One Drop receives 3rd party validation of its diabetes and hypertension outcomes with a financial guarantee.

Company adds senior hires in commercial and R&D groups to support Unity launch and pipeline development..

Lifescan launches eCommerce site offering personalized wellness programs for people living with diabetes.