Insulin & Pumps

Dexcom to Develop a “Smart Transmitter” as Part of JDRF Artificial Pancreas Project


JDRF and Dexcom announced that they have formed a partnership whose goal is to accelerate the development of a novel wireless “smart transmitter” that would allow a continuous glucose monitor (CGM) system to communicate directly with an artificial pancreas control device currently being used for research studies, instead of only with...



Ultra Long Acting Insulin Degludec Reduces Nocturnal Hypoglycemia, New Studies Show


Two new phase 3 studies published in The Lancet show that ultra long acting insulin, Degludec, an investigational compound from Novo Nordisk, significantly reduces the rates of nocturnal hypoglycemia by 25%, compared to insulin glargine. The two studies included in total 1,635 participants and investigated insulin degludec compared to...



Positive Results for Biodel’s Ultra Rapid Acting Insulin


Biodel Inc. announced positive top-line results from a Phase 1 clinical trial of its product candidates, BIOD-123 and BIOD-125 — two proprietary ultra rapid acting formulations of recombinant human insulin (RHI). The objective of the trial was to identify an RHI-based formulation with pharmacokinetic and pharmacodynamic profiles...



FDA Approves Novo Nordisk’s Levemir Insulin for Pregnant Women with Diabetes


The U.S. FDA has approved Novo Nordisk’s Levemir insulin (insulin detemir [rDNA origin] injection) for use by pregnant women with diabetes, giving it a Category B classification, indicating that it does not increase the risk of harm to the unborn baby. The label update makes Levemir the first and only basal insulin analog to have...



First US Artificial Pancreas Outpatient Trial Approved by FDA


The U.S. Food and Drug Administration (FDA) has approved the first outpatient artificial pancreas trial in the United States, marking a critical development in the effort by JDRF and its allies to bring this innovative and lifesaving diabetes technology to people with type 1 diabetes.   The JDRF-funded study will test an artificial...



Low Glucose Suspend Feature Proves Effective in Controlling Hypoglycemia


Medtronic has announced that the results of the in-clinic ASPIRE (Automation to Simulate Pancreatic Insulin REsponse) study met its efficacy endpoints and showed a 19% reduction in time spent below the low glucose threshold in patients using the MiniMed Paradigm System featuring Low Glucose Suspend automation, compared to conventional...



Insulet to Integrate LifeScan’s OneTouch into Next Generation OmniPod


Insulet Corporation, the company behind OmniPod Insulin Management System, announced it has signed a worldwide agreement with LifeScan, Inc. to integrate LifeScan’s OneTouch blood glucose monitoring technology into the OmniPod Personal Diabetes Manager (“PDM”). Currently OmniPod PDM’s use Abbott’s FreeSyle...



Cellnovo Launches World’s First Mobile-Connected Insulin Pump


British based Cellnovo announced the commercial launch of the its new mobile-connected diabetes management system, and the start of the largest usability trial ever to investigate insulin pump technology for patients with type 1 diabetes. The trial will also be the first in which all clinical data is captured remotely, in real-time,...



DexCom and Tandem to Integrate CGM into Next Generation Pumps


Continuous glucose monitoring systems maker DexCom, Inc. and Tandem, the developer of first ever touch-screen insulin pump, announced that they have signed a Development and Commercialization Agreement to integrate a future generation of DexCom’s continuous glucose monitoring (CGM) technology with Tandem’s t:slim(TM) Insulin...



Medtronic Launches mySentry the First-Of-Its-Kind Remote Glucose Monitor


Medtronic announced the U.S. market launch of the first-of-its-kind mySentry™ Remote Glucose Monitor, which allows a parent or caregiver to monitor from another room a patient’s MiniMed Paradigm® REAL-Time Revel™ System. The remote glucose monitor also marks the launch of a new category of Connected Care solutions that...



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