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Insuring insulin pump technology against hackers

DPP-4 inhibitor linagliptin launched for adults with T2D
Linagliptin (BI and Lilly) – the first one dosage strength dipeptidyl peptidase-4 (DPP-4) inhibitor licensed specifically for people with type 2 diabetes and renal impairment – was launched in the UK in September.

In clinical trials linagliptin delivered significant HbA1c reductions compared with placebo and was generally well tolerated.

Linagliptin is the only DPP-4 inhibitor primarily excreted via the bile, and the first treatment in this class licensed for use in type 2 diabetes irrespective of degree of renal impairment, with no dose adjustment or additional treatment-related monitoring required.

The potential for cyber attacks on medical devices has been recognised by Medtronic, which has asked software security experts to investigate the safety of its insulin pumps. This follows a claim that at least one of its devices could be hacked to dose people with diabetes with potentially lethal levels of insulin.

While there are no known examples of such a cyber attack on a medical device, security software maker McAfee exposed the new vulnerability in one model of the Medtronic Paradigm insulin pump and believes there could be similar risks in others.

“This is an evolution from having to think about security and safety as a healthcare company, and really about keeping people safe on our therapy, to this different question about keeping people safe around criminal or malicious intent,” Catherine Szyman, President of Medtronic’s diabetes division, said in an interview.

The US Food and Drug Administration said that there is no evidence of widespread problems from medical device security breaches. It says that any system with wireless communication can be subject to interception of data and compromised privacy as well as interference with performance that can compromise the safety and effectiveness of the device.

Diabetes UK launch the “Tracker” iPhone app
To help make diabetes management easier, Diabetes UK has created Diabetes UK Tracker, an app for iPhone and iPod Touch. The app provides users with a place to store and monitor their data and get a better idea about what might be affecting their blood glucose levels.

Developed by a range of experts including people with diabetes, clinical specialists and user experience professionals, the app allows users not only to record data, but also share it with their healthcare professionals and visualise their results across days and weeks. 

As well as being able to log blood glucose levels and store blood pressure and blood fat recordings, the app also allows users to track how they are feeling to help recognise patterns. Users can then save specific records as talking points to use as reminders in healthcare appointments.

Campaign to raise hypo awareness in UK drivers
“Are You Running on Empty?” is a new educational campaign launched to raise awareness around the prevention and management of hypoglycaemia among drivers with type 2 diabetes and their healthcare professionals.

A collaboration between the diabetes nursing group TREND-UK, the Automobile Association and MSD Diabetes, the campaign was launched to coincide with evolving regulations from the Driver and Vehicle Licensing Agency relating to changes in medical standards for people who hold a UK driving licence for personal or commercial vehicles. 

From 15 November 2011, new legislation will mean that drivers with type 1 or type 2 diabetes taking insulin may, for the first time, be allowed to apply for a Group 2 licence (heavy goods or passenger service vehicles), if they fulfil strict criteria for monitoring and controlling their blood glucose.

Campaign to raise hypo awareness in UK drivers
“Are You Running on Empty?” is a new educational campaign launched to raise awareness around the prevention and management of hypoglycaemia among drivers with type 2 diabetes and their healthcare professionals.

A collaboration between the diabetes nursing group TREND-UK, the Automobile Association and MSD Diabetes, the campaign was launched to coincide with evolving regulations from the Driver and Vehicle Licensing Agency relating to changes in medical standards for people who hold a UK driving licence for personal or commercial vehicles. 

From 15 November 2011, new legislation will mean that drivers with type 1 or type 2 diabetes taking insulin may, for the first time, be allowed to apply for a Group 2 licence (heavy goods or passenger service vehicles), if they fulfil strict criteria for monitoring and controlling their blood glucose.

Insulin detemir approved as add-on therapy to liraglutide
Insulin detemir, Novo Nordisk’s basal insulin analogue, has been approved by the European Commission as add-on therapy to Novo Nordisk’s glucagon-like peptide-1 (GLP-1) analogue, liraglutide, in combination with metformin in people with type 2 diabetes.

The extended license to market insulin detemir in the European Union is based on a positive opinion granted on
22 September by the European Committee for Medicinal Products for Human Use (CHMP) and the data from a randomised, open-label, 52-week clinical trial conducted to evaluate the safety and efficacy of adding once-daily insulin detemir to treatment with liraglutide 1.8 mg plus metformin. 

“We are pleased with the fast approval on the usage of insulin detemir as add-on to liraglutide in combination with metformin,” said Alan Moses, Global Chief Medical Officer at Novo Nordisk.

Insulin detemir approved as add-on therapy to liraglutide
Insulin detemir, Novo Nordisk’s basal insulin analogue, has been approved by the European Commission as add-on therapy to Novo Nordisk’s glucagon-like peptide-1 (GLP-1) analogue, liraglutide, in combination with metformin in people with type 2 diabetes.

The extended license to market insulin detemir in the European Union is based on a positive opinion granted on 22 September by the European Committee for Medicinal Products for Human Use (CHMP) and the data from a randomised, open-label, 52-week clinical trial conducted to evaluate the safety and efficacy of adding once-daily insulin detemir to treatment with liraglutide 1.8 mg plus metformin.

“We are pleased with the fast approval on the usage of insulin detemir as add-on to liraglutide in combination with metformin,” said Alan Moses, Global Chief Medical Officer at Novo Nordisk.

DPP-4 inhibitor linagliptin launched for adults with T2D
Linagliptin (BI and Lilly) – the first one dosage strength dipeptidyl peptidase-4 (DPP-4) inhibitor licensed specifically for people with type 2 diabetes and renal impairment – was launched in the UK in September.

In clinical trials linagliptin delivered significant HbA1c reductions compared with placebo and was generally well tolerated.

Linagliptin is the only DPP-4 inhibitor primarily excreted via the bile, and the first treatment in this class licensed for use in type 2 diabetes irrespective of degree of renal impairment, with no dose adjustment or additional treatment-related monitoring required.

The potential for cyber attacks on medical devices has been recognised by Medtronic, which has asked software security experts to investigate the safety of its insulin pumps. This follows a claim that at least one of its devices could be hacked to dose people with diabetes with potentially lethal levels of insulin.

While there are no known examples of such a cyber attack on a medical device, security software maker McAfee exposed the new vulnerability in one model of the Medtronic Paradigm insulin pump and believes there could be similar risks in others.

“This is an evolution from having to think about security and safety as a healthcare company, and really about keeping people safe on our therapy, to this different question about keeping people safe around criminal or malicious intent,” Catherine Szyman, President of Medtronic’s diabetes division, said in an interview.

The US Food and Drug Administration said that there is no evidence of widespread problems from medical device security breaches. It says that any system with wireless communication can be subject to interception of data and compromised privacy as well as interference with performance that can compromise the safety and effectiveness of the device.

Diabetes UK launch the “Tracker” iPhone app
To help make diabetes management easier, Diabetes UK has created Diabetes UK Tracker, an app for iPhone and iPod Touch. The app provides users with a place to store and monitor their data and get a better idea about what might be affecting their blood glucose levels.

Developed by a range of experts including people with diabetes, clinical specialists and user experience professionals, the app allows users not only to record data, but also share it with their healthcare professionals and visualise their results across days and weeks. 

As well as being able to log blood glucose levels and store blood pressure and blood fat recordings, the app also allows users to track how they are feeling to help recognise patterns. Users can then save specific records as talking points to use as reminders in healthcare appointments.

Campaign to raise hypo awareness in UK drivers
“Are You Running on Empty?” is a new educational campaign launched to raise awareness around the prevention and management of hypoglycaemia among drivers with type 2 diabetes and their healthcare professionals.

A collaboration between the diabetes nursing group TREND-UK, the Automobile Association and MSD Diabetes, the campaign was launched to coincide with evolving regulations from the Driver and Vehicle Licensing Agency relating to changes in medical standards for people who hold a UK driving licence for personal or commercial vehicles. 

From 15 November 2011, new legislation will mean that drivers with type 1 or type 2 diabetes taking insulin may, for the first time, be allowed to apply for a Group 2 licence (heavy goods or passenger service vehicles), if they fulfil strict criteria for monitoring and controlling their blood glucose.

Campaign to raise hypo awareness in UK drivers
“Are You Running on Empty?” is a new educational campaign launched to raise awareness around the prevention and management of hypoglycaemia among drivers with type 2 diabetes and their healthcare professionals.

A collaboration between the diabetes nursing group TREND-UK, the Automobile Association and MSD Diabetes, the campaign was launched to coincide with evolving regulations from the Driver and Vehicle Licensing Agency relating to changes in medical standards for people who hold a UK driving licence for personal or commercial vehicles. 

From 15 November 2011, new legislation will mean that drivers with type 1 or type 2 diabetes taking insulin may, for the first time, be allowed to apply for a Group 2 licence (heavy goods or passenger service vehicles), if they fulfil strict criteria for monitoring and controlling their blood glucose.

Insulin detemir approved as add-on therapy to liraglutide
Insulin detemir, Novo Nordisk’s basal insulin analogue, has been approved by the European Commission as add-on therapy to Novo Nordisk’s glucagon-like peptide-1 (GLP-1) analogue, liraglutide, in combination with metformin in people with type 2 diabetes.

The extended license to market insulin detemir in the European Union is based on a positive opinion granted on
22 September by the European Committee for Medicinal Products for Human Use (CHMP) and the data from a randomised, open-label, 52-week clinical trial conducted to evaluate the safety and efficacy of adding once-daily insulin detemir to treatment with liraglutide 1.8 mg plus metformin. 

“We are pleased with the fast approval on the usage of insulin detemir as add-on to liraglutide in combination with metformin,” said Alan Moses, Global Chief Medical Officer at Novo Nordisk.

Insulin detemir approved as add-on therapy to liraglutide
Insulin detemir, Novo Nordisk’s basal insulin analogue, has been approved by the European Commission as add-on therapy to Novo Nordisk’s glucagon-like peptide-1 (GLP-1) analogue, liraglutide, in combination with metformin in people with type 2 diabetes.

The extended license to market insulin detemir in the European Union is based on a positive opinion granted on 22 September by the European Committee for Medicinal Products for Human Use (CHMP) and the data from a randomised, open-label, 52-week clinical trial conducted to evaluate the safety and efficacy of adding once-daily insulin detemir to treatment with liraglutide 1.8 mg plus metformin.

“We are pleased with the fast approval on the usage of insulin detemir as add-on to liraglutide in combination with metformin,” said Alan Moses, Global Chief Medical Officer at Novo Nordisk.

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