RE: for pump users

[Guest guest]

This is all well and good for the children and adolescents (who I am assuming

are sighted), but what about the blind diabetics who are pump users? It's

dangerous enough taking care of our disease, which in most cases caused our

blindness, and the chief piece of equipment just beeps at us. Sure we can count

the number of beeps,but have you ever tried to do this while having a low or

high BSL? I write Minimed medtronic 2 times a year regarding this issue, and

get the same reply ( " we willl consider it in our next release "

Maybe some of us should die due to pump problems and really get the companies

attention and the FDA for that matter. I for one, will not volunteer for this

though.

for pump users

New Standards for Safer Insulin Pump Use Needed

Diabetes In Control. the following

Newsletter

, and this

Category

New Standards for Safer Insulin Pump Use Needed

A physician at the FDA, provided new data that shows there is a serious

problem regarding patient safety in insulin pump use. She reported data

on 1594

injuries and 13 deaths in children and adolescents collected over 10

years. 82% of the cases resulted in hospitalization.

The American Association of Clinical Endocrinologists applauds the FDA's

efforts to protect the safety of children and adolescents who are using

insulin

pumps, " said Dr. Hellman, the Association's President.

In the May edition of Pediatrics, Dr. Judith Cope, The most common

single issue was lack of education and, neither the patient nor the

responsible adult

knew enough about how the pump worked to avoid the injury or death that

resulted. Although there were some cases due to mechanical malfunction

of the pump,

most problems were the result of human factors involved in the use of

the pumps.

Unfortunately, the FDA has not yet provided similar data regarding the

numbers of serious injuries in the larger group of pump users, adults

who are using

insulin pumps. This data, which is critically important, is very

difficult to obtain and only the FDA is likely to have the ability to

have access to the

data of injuries and deaths from all of the manufacturers of insulin

pumps.

There is every reason to be concerned that the data from insulin pump

use in adults will also indicate a significant number of injuries and

deaths similar

to those found in the pediatric study. " The factors noted in the

pediatric study that contributed to poor outcomes in children and

adolescents can be expected

to be present in a significant proportion of the adult population on

insulin pumps, " said Dr. Hellman.

Limited access to education at the time of initiation of pump therapy

was a common problem in children and adolescents. It may be even more of

a problem

in adults. So is the lack of availability of support for pump use in

emergencies. Many physicians and their staff who care for patients on

insulin pumps

are not sufficiently knowledgeable about the pump's performance to be

able to troubleshoot when the patient makes a mistake or the pump

malfunctions. Although

telephone support is usually available from the manufacturer: the

support personnel are neither the prescribers of the insulin doses nor

directly involved

in the patient's care.

In addition, as inadequate insurance coverage for adults becomes more

common, new barriers to continuing care develop. Moreover, many new

pumps are very

sophisticated and complex, and their complexity can overwhelm even

experienced users, and greatly increase the risk of error in patients

who are inexperienced

with pumps, or distracted, anxious, depressed, or having any transient

cognitive problems as often occurs with either severely low or high

blood glucose

levels.

Dr. Hellman said that the American Association of Clinical

Endocrinologists has an annual program, now in its third year, to teach

and provide hands-on

experience to all physicians completing specialized training in

endocrinology. They are taught how to care for patients on insulin

pumps, how to protect

them from harm due to pump malfunction, and how to improve their

patient's skills in using an insulin pump safely and well. The

physicians find the program

most valuable, but more such programs are needed. " This past year we

appointed a task force of pump experts to develop guidelines and

standards for initiating

pump use and what we consider essential to provide for the safe and

effective medical care of those on insulin pumps. "

The American Association of Clinical Endocrinologists is very supportive

of insulin pump technology and believes more patients can benefit from

these pumps.

But it is also clear that there are a significant number of patients who

should not have been placed on these pumps. Dr. Hellman said, " These

include patients

with severe emotional problems that distract them from their safe

self-care, as well as patients who cannot deal with the complexity of

the pumps, suffer

cognitive overload as a result, and do poorly. Most patients need more

education and informed medical support, and nearly all do better in an

integrated

program that coordinates their diabetic care. But a continuing problem

is that the education, both initial and continuing, and the medical

support to deal

with the specific problems and needs of pump users, is neither being

provided nor paid for. As a result, we have a patient safety problem

that may not

be the pump itself, but a systems problem, that is, a failure of the

system of care for pump support. The FDA needs to obtain the safety data

on insulin

pumps and share it with the scientific community as soon as possible. We

need to move forward to make insulin pump use safer, and allow for the

elimination

of the deaths and injuries in pump use as those reported by Dr. Cope and

the FDA team. "

May 2008 edition of Pediatrics

[Guest guest]

, You make a very importamt point, and I, too, will continue to use

syringes and the pen until we both get a suitable answer. The first thing to go

during a moderate hypoglycemic reaction is one's judgement. Judgement is

definitely gone during a severe hypoglycemic reaction.

for pump users

New Standards for Safer Insulin Pump Use Needed

Diabetes In Control. the following

Newsletter

, and this

Category

New Standards for Safer Insulin Pump Use Needed

A physician at the FDA, provided new data that shows there is a serious

problem regarding patient safety in insulin pump use. She reported data

on 1594

injuries and 13 deaths in children and adolescents collected over 10

years. 82% of the cases resulted in hospitalization.

The American Association of Clinical Endocrinologists applauds the FDA's

efforts to protect the safety of children and adolescents who are using

insulin

pumps, " said Dr. Hellman, the Association's President.

In the May edition of Pediatrics, Dr. Judith Cope, The most common

single issue was lack of education and, neither the patient nor the

responsible adult

knew enough about how the pump worked to avoid the injury or death that

resulted. Although there were some cases due to mechanical malfunction

of the pump,

most problems were the result of human factors involved in the use of

the pumps.

Unfortunately, the FDA has not yet provided similar data regarding the

numbers of serious injuries in the larger group of pump users, adults

who are using

insulin pumps. This data, which is critically important, is very

difficult to obtain and only the FDA is likely to have the ability to

have access to the

data of injuries and deaths from all of the manufacturers of insulin

pumps.

There is every reason to be concerned that the data from insulin pump

use in adults will also indicate a significant number of injuries and

deaths similar

to those found in the pediatric study. " The factors noted in the

pediatric study that contributed to poor outcomes in children and

adolescents can be expected

to be present in a significant proportion of the adult population on

insulin pumps, " said Dr. Hellman.

Limited access to education at the time of initiation of pump therapy

was a common problem in children and adolescents. It may be even more of

a problem

in adults. So is the lack of availability of support for pump use in

emergencies. Many physicians and their staff who care for patients on

insulin pumps

are not sufficiently knowledgeable about the pump's performance to be

able to troubleshoot when the patient makes a mistake or the pump

malfunctions. Although

telephone support is usually available from the manufacturer: the

support personnel are neither the prescribers of the insulin doses nor

directly involved

in the patient's care.

In addition, as inadequate insurance coverage for adults becomes more

common, new barriers to continuing care develop. Moreover, many new

pumps are very

sophisticated and complex, and their complexity can overwhelm even

experienced users, and greatly increase the risk of error in patients

who are inexperienced

with pumps, or distracted, anxious, depressed, or having any transient

cognitive problems as often occurs with either severely low or high

blood glucose

levels.

Dr. Hellman said that the American Association of Clinical

Endocrinologists has an annual program, now in its third year, to teach

and provide hands-on

experience to all physicians completing specialized training in

endocrinology. They are taught how to care for patients on insulin

pumps, how to protect

them from harm due to pump malfunction, and how to improve their

patient's skills in using an insulin pump safely and well. The

physicians find the program

most valuable, but more such programs are needed. " This past year we

appointed a task force of pump experts to develop guidelines and

standards for initiating

pump use and what we consider essential to provide for the safe and

effective medical care of those on insulin pumps. "

The American Association of Clinical Endocrinologists is very supportive

of insulin pump technology and believes more patients can benefit from

these pumps.

But it is also clear that there are a significant number of patients who

should not have been placed on these pumps. Dr. Hellman said, " These

include patients

with severe emotional problems that distract them from their safe

self-care, as well as patients who cannot deal with the complexity of

the pumps, suffer

cognitive overload as a result, and do poorly. Most patients need more

education and informed medical support, and nearly all do better in an

integrated

program that coordinates their diabetic care. But a continuing problem

is that the education, both initial and continuing, and the medical

support to deal

with the specific problems and needs of pump users, is neither being

provided nor paid for. As a result, we have a patient safety problem

that may not

be the pump itself, but a systems problem, that is, a failure of the

system of care for pump support. The FDA needs to obtain the safety data

on insulin

pumps and share it with the scientific community as soon as possible. We

need to move forward to make insulin pump use safer, and allow for the

elimination

of the deaths and injuries in pump use as those reported by Dr. Cope and

the FDA team. "

May 2008 edition of Pediatrics

[Guest guest]

, You make a very importamt point, and I, too, will continue to use

syringes and the pen until we both get a suitable answer. The first thing to go

during a moderate hypoglycemic reaction is one's judgement. Judgement is

definitely gone during a severe hypoglycemic reaction.

for pump users

New Standards for Safer Insulin Pump Use Needed

Diabetes In Control. the following

Newsletter

, and this

Category

New Standards for Safer Insulin Pump Use Needed

A physician at the FDA, provided new data that shows there is a serious

problem regarding patient safety in insulin pump use. She reported data

on 1594

injuries and 13 deaths in children and adolescents collected over 10

years. 82% of the cases resulted in hospitalization.

The American Association of Clinical Endocrinologists applauds the FDA's

efforts to protect the safety of children and adolescents who are using

insulin

pumps, " said Dr. Hellman, the Association's President.

In the May edition of Pediatrics, Dr. Judith Cope, The most common

single issue was lack of education and, neither the patient nor the

responsible adult

knew enough about how the pump worked to avoid the injury or death that

resulted. Although there were some cases due to mechanical malfunction

of the pump,

most problems were the result of human factors involved in the use of

the pumps.

Unfortunately, the FDA has not yet provided similar data regarding the

numbers of serious injuries in the larger group of pump users, adults

who are using

insulin pumps. This data, which is critically important, is very

difficult to obtain and only the FDA is likely to have the ability to

have access to the

data of injuries and deaths from all of the manufacturers of insulin

pumps.

There is every reason to be concerned that the data from insulin pump

use in adults will also indicate a significant number of injuries and

deaths similar

to those found in the pediatric study. " The factors noted in the

pediatric study that contributed to poor outcomes in children and

adolescents can be expected

to be present in a significant proportion of the adult population on

insulin pumps, " said Dr. Hellman.

Limited access to education at the time of initiation of pump therapy

was a common problem in children and adolescents. It may be even more of

a problem

in adults. So is the lack of availability of support for pump use in

emergencies. Many physicians and their staff who care for patients on

insulin pumps

are not sufficiently knowledgeable about the pump's performance to be

able to troubleshoot when the patient makes a mistake or the pump

malfunctions. Although

telephone support is usually available from the manufacturer: the

support personnel are neither the prescribers of the insulin doses nor

directly involved

in the patient's care.

In addition, as inadequate insurance coverage for adults becomes more

common, new barriers to continuing care develop. Moreover, many new

pumps are very

sophisticated and complex, and their complexity can overwhelm even

experienced users, and greatly increase the risk of error in patients

who are inexperienced

with pumps, or distracted, anxious, depressed, or having any transient

cognitive problems as often occurs with either severely low or high

blood glucose

levels.

Dr. Hellman said that the American Association of Clinical

Endocrinologists has an annual program, now in its third year, to teach

and provide hands-on

experience to all physicians completing specialized training in

endocrinology. They are taught how to care for patients on insulin

pumps, how to protect

them from harm due to pump malfunction, and how to improve their

patient's skills in using an insulin pump safely and well. The

physicians find the program

most valuable, but more such programs are needed. " This past year we

appointed a task force of pump experts to develop guidelines and

standards for initiating

pump use and what we consider essential to provide for the safe and

effective medical care of those on insulin pumps. "

The American Association of Clinical Endocrinologists is very supportive

of insulin pump technology and believes more patients can benefit from

these pumps.

But it is also clear that there are a significant number of patients who

should not have been placed on these pumps. Dr. Hellman said, " These

include patients

with severe emotional problems that distract them from their safe

self-care, as well as patients who cannot deal with the complexity of

the pumps, suffer

cognitive overload as a result, and do poorly. Most patients need more

education and informed medical support, and nearly all do better in an

integrated

program that coordinates their diabetic care. But a continuing problem

is that the education, both initial and continuing, and the medical

support to deal

with the specific problems and needs of pump users, is neither being

provided nor paid for. As a result, we have a patient safety problem

that may not

be the pump itself, but a systems problem, that is, a failure of the

system of care for pump support. The FDA needs to obtain the safety data

on insulin

pumps and share it with the scientific community as soon as possible. We

need to move forward to make insulin pump use safer, and allow for the

elimination

of the deaths and injuries in pump use as those reported by Dr. Cope and

the FDA team. "

May 2008 edition of Pediatrics

[Guest guest]

You are exactly right. I spoke to a pumper group last Thurs., only a few of

which were visuall impaired. They awere all appalled when I told then all

pump companies have been approached a number of times by various

organizatins for the bline with no new outcome for blind. I sure hope

prodigycomes through with a talking pump soon.

Re: for pump users

This is all well and good for the children and adolescents (who I am

assuming are sighted), but what about the blind diabetics who are pump

users? It's dangerous enough taking care of our disease, which in most cases

caused our blindness, and the chief piece of equipment just beeps at us.

Sure we can count the number of beeps,but have you ever tried to do this

while having a low or high BSL? I write Minimed medtronic 2 times a year

regarding this issue, and get the same reply ( " we willl consider it in our

next release "

Maybe some of us should die due to pump problems and really get the

companies attention and the FDA for that matter. I for one, will not

volunteer for this though.

for pump users

New Standards for Safer Insulin Pump Use Needed

Diabetes In Control. the following

Newsletter

, and this

Category

New Standards for Safer Insulin Pump Use Needed

A physician at the FDA, provided new data that shows there is a serious

problem regarding patient safety in insulin pump use. She reported data

on 1594

injuries and 13 deaths in children and adolescents collected over 10

years. 82% of the cases resulted in hospitalization.

The American Association of Clinical Endocrinologists applauds the FDA's

efforts to protect the safety of children and adolescents who are using

insulin

pumps, " said Dr. Hellman, the Association's President.

In the May edition of Pediatrics, Dr. Judith Cope, The most common

single issue was lack of education and, neither the patient nor the

responsible adult

knew enough about how the pump worked to avoid the injury or death that

resulted. Although there were some cases due to mechanical malfunction

of the pump,

most problems were the result of human factors involved in the use of

the pumps.

Unfortunately, the FDA has not yet provided similar data regarding the

numbers of serious injuries in the larger group of pump users, adults

who are using

insulin pumps. This data, which is critically important, is very

difficult to obtain and only the FDA is likely to have the ability to

have access to the

data of injuries and deaths from all of the manufacturers of insulin

pumps.

There is every reason to be concerned that the data from insulin pump

use in adults will also indicate a significant number of injuries and

deaths similar

to those found in the pediatric study. " The factors noted in the

pediatric study that contributed to poor outcomes in children and

adolescents can be expected

to be present in a significant proportion of the adult population on

insulin pumps, " said Dr. Hellman.

Limited access to education at the time of initiation of pump therapy

was a common problem in children and adolescents. It may be even more of

a problem

in adults. So is the lack of availability of support for pump use in

emergencies. Many physicians and their staff who care for patients on

insulin pumps

are not sufficiently knowledgeable about the pump's performance to be

able to troubleshoot when the patient makes a mistake or the pump

malfunctions. Although

telephone support is usually available from the manufacturer: the

support personnel are neither the prescribers of the insulin doses nor

directly involved

in the patient's care.

In addition, as inadequate insurance coverage for adults becomes more

common, new barriers to continuing care develop. Moreover, many new

pumps are very

sophisticated and complex, and their complexity can overwhelm even

experienced users, and greatly increase the risk of error in patients

who are inexperienced

with pumps, or distracted, anxious, depressed, or having any transient

cognitive problems as often occurs with either severely low or high

blood glucose

levels.

Dr. Hellman said that the American Association of Clinical

Endocrinologists has an annual program, now in its third year, to teach

and provide hands-on

experience to all physicians completing specialized training in

endocrinology. They are taught how to care for patients on insulin

pumps, how to protect

them from harm due to pump malfunction, and how to improve their

patient's skills in using an insulin pump safely and well. The

physicians find the program

most valuable, but more such programs are needed. " This past year we

appointed a task force of pump experts to develop guidelines and

standards for initiating

pump use and what we consider essential to provide for the safe and

effective medical care of those on insulin pumps. "

The American Association of Clinical Endocrinologists is very supportive

of insulin pump technology and believes more patients can benefit from

these pumps.

But it is also clear that there are a significant number of patients who

should not have been placed on these pumps. Dr. Hellman said, " These

include patients

with severe emotional problems that distract them from their safe

self-care, as well as patients who cannot deal with the complexity of

the pumps, suffer

cognitive overload as a result, and do poorly. Most patients need more

education and informed medical support, and nearly all do better in an

integrated

program that coordinates their diabetic care. But a continuing problem

is that the education, both initial and continuing, and the medical

support to deal

with the specific problems and needs of pump users, is neither being

provided nor paid for. As a result, we have a patient safety problem

that may not

be the pump itself, but a systems problem, that is, a failure of the

system of care for pump support. The FDA needs to obtain the safety data

on insulin

pumps and share it with the scientific community as soon as possible. We

need to move forward to make insulin pump use safer, and allow for the

elimination

of the deaths and injuries in pump use as those reported by Dr. Cope and

the FDA team. "

May 2008 edition of Pediatrics