24-Hour Crisis Hotline: (877)SAFEGBC or (877)723-3422 Mental Health & Substance Abuse Issues

6502 Nursery Drive, Suite 100
Victoria, TX 77904
Fax: (361)578-5500

Basic InformationLatest News
Have Diabetes? Don't Lose Sight of Danger to Your EyesCommon Diabetes Meds Linked to Higher Odds for a Serious ComplicationAHA News: Controlling Diabetes Takes on Greater Urgency During COVID-19 PandemicStressful Days, Worse Blood Sugar Control for People With DiabetesAnimal Tests Point to Possible Path to Ultrafast InsulinSigns of Developing Adult Diabetes Seen as Early as Age 8: StudyDoes COVID-19 Trigger New Cases of Diabetes?Telehealth Programs Improve Blood Sugar for Rural Americans With DiabetesContinuous Glucose Monitors Help With Type 1 Diabetes at Any AgeCost of Type 1 Diabetes: $2,500 a Year With Insurance1 in 10 Hospitalized COVID-19 Patients With Diabetes Dies: StudyWhite House Announces Plan for Medicare Recipients to Get Insulin at $35 Per MonthLost Pregnancies, Diabetes May Be LinkedType 2 Diabetes Linked to Worse Mental Outcomes After StrokeSleep Apnea Tied to Raised Diabetes Risk in Black AmericansHeart Attacks, Strokes Are Declining Among People With DiabetesCould Your Contact Lenses Track, Treat Your Diabetes?AHA News: Managing Diabetes Risk in Hispanic, Asian CommunitiesObesity Is Biggest Type 2 Diabetes Risk FactorAHA News: Understanding the Risky Combination of Diabetes and the CoronavirusWhy Is Coronavirus a Bigger Worry for People With Diabetes?What People With Type 1 Diabetes Need to Know About COVID-19Family Ties Help Young Adults With Type 1 Diabetes FlourishPatch Pump Device Could Offer Cheaper Insulin DeliveryCan AI Predict Who Will Develop Diabetes?Blood Sugar Control May Aid Stroke Recovery in Diabetes PatientsBacteria May Be a Player in Diabetes Among Very ObeseNew Tool Helps Muslims With Diabetes Manage Blood Sugar During Ramadan FastWant to Help Keep Diabetes at Bay? Brush & FlossDiabetes Among U.S. Young, Especially Asians, Continues to ClimbDrug Duo Speeds Regeneration of Key Cells Lost in DiabetesMedicare Could Save Billions If Allowed to Negotiate Insulin PricesAt the Barbershop, a Trim -- and a Diabetes ScreeningCertain Diabetes Meds May Lower Gout Risk, TooBig Advances Made Against Diabetes in 2019CDC Study Breaks Down Diabetes Risk for Hispanic, Asian SubgroupsFDA Authorizes Marketing of Automated Insulin Dosing ControllerDo Processed Foods Up Your Type 2 Diabetes Risk?Changing Timing, Frequency of Meals May Help With Diabetes'Diabetes Burnout' Is Real, Here's How to CopeAs Diabetes Costs Soar, Many Turn to Black Market for HelpFDA Testing Levels of Carcinogen in Diabetes Drug MetforminMom-to-Be's Diabetes May Up Odds of Heart Disease in Her KidsPrediabetes Now Common Among Teens, Young AdultsHeart Attack at 44 Helped Her Realize Diabetes' DangersDiabetes Tougher on Women's HeartsDiabetes Technology Often Priced Out of ReachSupplements Don't Prevent Kidney Disease in Type 2 DiabeticsWhy Are Insulin Prices Still So High for U.S. Patients?Health Tip: Snacks for People With Diabetes
Related Topics

Medical Disorders

FDA Authorizes Marketing of Automated Insulin Dosing Controller

HealthDay News
Updated: Dec 19th 2019

new article illustration

THURSDAY, Dec. 19, 2019 (HealthDay News) -- The U.S. Food and Drug Administration recently approved marketing of an interoperable automated glycemic controller device, the Tandem Diabetes Care Control-IQ Technology, the agency announced last week.

The device automatically adjusts insulin delivery through connection to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM). According to the FDA, this controller is the first that can be used with other diabetes devices that are meant to be integrated into a diabetes management system for automated insulin delivery. With this marketing authorization, the FDA notes iCGMs and ACE pumps can be used with an interoperable automated glycemic controller as a complete automated insulin dosing (AID) system. Patients with type 1 diabetes can use the Control-IQ Technology controller with compatible iCGMs and ACE pumps to automatically increase, decrease, and suspend delivery of basal insulin based on insulin delivery history, iCGM readings, and predicted glucose values. The controller can also automatically deliver insulin when the glucose value is predicted to exceed a predefined number.

Approval was based on data from a clinical trial of 168 patients with type 1 diabetes randomly assigned to use the Control-IQ Technology controller installed on a Tandem t:slim X2 insulin pump or a CGM and insulin pump without the Control-IQ Technology controller. Data revealed the controller determined and commanded safe and effective insulin delivery from a compatible ACE pump based on iCGM readings. The controller was also assessed for its ability to communicate with the entire system with appropriate reliability, cybersecurity, and fail-safe modes. However, the FDA notes that despite these assessments, there is still a risk for delayed insulin delivery.

Other risks associated with the interoperable controller include incorrect insulin delivery due to loss of communication between connected devices or from cybersecurity issues.

Marketing authorization of the Control-IQ Technology controller was granted to Tandem Diabetes Care Inc.

More Information