Medical Devices Advisory Committee




НазваниеMedical Devices Advisory Committee
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and an aid for management as interpreted by the diabetic team, the diabetic care team and also it is for trends.

DR. NIPPER: Mr. Reed.

MR. REED: Overall, I think it is okay, but I think you need to make sure that the people who are using it, not only the patients but the physicians, understand clearly the statistical process and how to interpret the data that they get. As a diabetic for 45 years, I have encountered a lot of physicians who really don't know how to deal with these things and that has to be addressed.

DR. NIPPER: Ms Kruger.

MS. KRUGER: The only addition I would make is to label it with the best or the most appropriate frequency of blood glucose monitoring that would give you the best standards.

DR. NIPPER: Dr. Habig.

DR. HABIG: Since I actually haven't seen the labeling only the indications for use statement, I really don't have input other than to reflect an earlier comment that most physicians who treat people with diabetes are not diabetologists and, so, ensuring that they understand what they are doing as they use this device for a person under their care needs to be considered carefully.

DR. NIPPER: Thank you.

Dr. Janosky.

DR. JANOSKY: By examining the indications for use, I have no suggestions, but I do have a question.

Is the indication for use in the labeling a statement for individuals with diabetes in general or is it limiting to the type of diabetes? I don't have it in front of me.

DR. NIPPER: I don't have it in front of me either. It is in my box behind me.

MS. LAPPALAINEN: Tina, could you put up the indications for use slides?

DR. NIPPER: I have the indications for use. I just don't have the labeling.

MS. LAPPALAINEN: Tina, that is okay.

DR. NIPPER: I am not sure where we go from here because we don't have that piece of information that you want.

MS. LAPPALAINEN: If you would like, we would take your written comments regarding the labeling. We will communicate those with the sponsor and that is true of anyone else. If you would like to write your response to any of these questions and submit that formally to FDA, we will communicate that with the sponsor.

DR. NIPPER: Thank you.

Dr. Everett, labeling?

DR. EVERETT: It seems mostly okay, with the exception of (c) and (d). (c) needs some work. And then (d) needs some kind of educational pamphlet for physicians to understand what to do about calibration problems. And if it goes as is, then I would hate for it to do that, but if more work is not done on Type 2s and African Americans, then the device should read on the labelling, it should say the device is not proven to work in Type 2 diabetics and African Americans and I picked African Americans because of the high incidence of diabetes in that group and I am sure tons of patients will end up having this device used on them. So, unless that is corrected, it should be written right on the label.

DR. NIPPER: Thank you.

Dr. Clement.

DR. CLEMENT: Again, without having the labeling, it is almost impossible to comment, but I would comment as far as the manual is concerned, and that may be reflected in the labeling as well is that the more accurate the blood glucose determinations are done by the patient, the more valuable this data is going to be.

That will narrow that part of the error equation. So, one thing I would recommend -- and, again, this is a suggestion -- is that the patient be told and instructed to use the same meter, make sure it -- excuse me -- not calibrated but within accurate readings in terms of the glucose solutions, using the same code of strips to eliminate as much as possible the source of error coming from the glucose machine where these numbers are paired up and looking at the trend data.

DR. NIPPER: Thanks.

I apologize for interrupting but the reason I don't have the labeling in front of me is mine is packed up in a box behind here, but for those of you who have your books, the submission, it is in Volume 1 of 2 of the October 30th, 1998 book. And if you --

DR. HABIG: I have to point something out. So, the panel knows, labeling is an FDA term that includes the operator manual, the instruction manual, labels.

DR. NIPPER: I have read it but it was several weeks ago.

Sharon, did you have something?

MS. LAPPALAINEN: I just wanted to make a point. If you plan to review the labeling and send us a review of the labeling, please retain this volume to take home with you so that you can review the labeling. Otherwise, if you plan to leave the information here, FDA will count that. We have to account for all of the information that we have given to you. So, if you plan to comment on the labeling, take action to secure that document.

DR. NIPPER: It is Volume 1 of 2 of the October 30th premarket amendment.

DR. ROSENBLOOM: My turn?

DR. NIPPER: Yes.

DR. ROSENBLOOM: I have the same problem. I reviewed this early in February and I had some comments about some specific matters, which I don't think I need to go into. I can just give you those to you, right, about hand washing and so on. I think that I was concerned about the information for patients. I thought that it was written in an awkward style and it really needed to be looked at by a diabetes educator, a medical writer, who deals with the 8th grade level sort of thing. It really needs polishing up. It is quite stilted.

One definition in particular startled me. It was surprising to find out that ketones are poisonous or toxic substances formed by the breakdown of fats. My body doesn't know that. It likes to burn them when I don't eat as energy. So, I am glad my body doesn't know that they are toxic and poisonous substances. Otherwise, I would be in pretty bad shape.

DR. NIPPER: Dr. Rosenbloom, you stole my suggestion. I was going to say give that manual to a bunch of diabetes educators and they will straighten that in no time at all.

Dr. Falls, do you have comments on the labeling?

DR. HARRINGTON FALLS: This is Dr. Falls.

I won't be writing down my projections. I am just going to run through and give them all right now.

Intended use is for the diabetes management team, not for the patient to manage themselves. For (b), I believe there will be additional future applications. So, it might not necessarily be limited to generating trends only. For (c), I believe, more data is needed and I have already mentioned the fluid issues.

For (d), again, most diabetics are managed with collaborative care teams currently and I think that will be the most appropriate situation because many clinicians are not up to date with the current options.

For (e), since the study itself was based on the Type 1 diabetics on insulin, as the device as more data generated, I believe it will be able to be used for any major change in insulin or oral medication regimens.

For (f), I would just like to commend the sponsor because I think it is a very elegant design and I hope that we won't end up with an allergy situation when a lot of people are exposed to certain substances, as we did with latex.

DR. NIPPER: Why don't you go ahead and tackle 8 and we will go back around the room this way.

DR. HARRINGTON FALLS: Okay. For 8, suggestions for patient education, use pictures to demonstrate how the device should be used and then just make sure it is mentioned, the health care provider must interpret the data.

DR. NIPPER: Thanks.

Dr. Rosenbloom, 8?

DR. ROSENBLOOM: I think I already covered that that the materials need to be done in a more appropriate manner in terms of accuracy of the metabolic information, as well as the style so that it is easily accessible by the patient.

DR. NIPPER: Thank you.

Dr. Clement, do you have suggestions for 8?

DR. CLEMENT: Yes. Also, since I was corrected about that the manual is part of the labeling -- I was naive about that -- one thing that struck me -- again, I concur that someone like Davida Kruger or a group of nurse educators could go through this. One of the first things that struck me on the first description on page 4, it says continuous glucose monitoring system is a holter cell sensor. I know what that is, but I am sure the patient doesn't know what that is right off the bat.

So, it may help -- this is the first paragraph on what this thing is about. I would suggest deleting the holter description right there. It is very useful to know the analogy of what it is similar to in terms of looking at retrospective data, but right from the bat, the patient is going to not know what this person is talking about.

But as far as patient education, I think this is a very sophisticated device. It is going to take a tremendous amount of patient education. I think that should be, you know, very -- you know, put together in a very simplified manual as much as possible. I would suggest the manufacturers' part of the distribution process, that you actually identify centers to have trainers just as the glucose MiniMed, Dysotronic(?) and other countries have training programs to actually train people for drugs. You really only essentially for something like this need to have trainers to be certified, so to speak, that know really what they are doing this goes to the patients because I think there is a safety issue, that if this is put in a box and given to people and given to physicians, nurse educators to slap on a patient, that there could potentially be some problems with that.

DR. NIPPER: Thank you.

Dr. Everett, do you have patient education concerns?

DR. EVERETT: I will have to read it again and I will see the comments, but my problem with most patient education booklets is, as was mentioned, they have these technical terms and the patients still don't know what they mean. I will look at it and if there is a lot of stuff like that in there, then I will point that out.

DR. NIPPER: Thank you.

Dr. Janosky.

DR. JANOSKY: I would just agree with the timing issue in terms of diabetic educators and some more information for the patients.

DR. NIPPER: Right. Thank you.

Dr. Habig.

DR. HABIG: The only suggestion I have in addition to the simplification and the straightforward terminology would be, perhaps, a video tape packaged with the electronics part would allow some real, you know, simplified way to present what it is and how it is used.

DR. NIPPER: Right. Thank you.

Ms. Kruger.

MS. KRUGER: That was actually my comment, too, is that we have been very successful with videos for patients to take home, view in the clinic and then take home and that I felt the book was a little too high level for most patients. I don't think it is as complex as Dr. Clement thinks. I think when you are working with pumps and meters that that is a different level. That is a long term that is easy enough for a nurse in a clinic with a physician because it is only a three day thing to be able to push this button and bring the information back.

Just to make sure you include the important things of clean technique, the need of blood glucose monitoring, a take home booklet for them to flip through with pictures in it. Just make it user friendly.

DR. NIPPER: Thank you.

Mr. Reed, do you have suggestions for the education package?

MR. REED: The idea of video is good. Pictures are always good. Case studies to let a person know how to

-- what to expect, what is happening, how it is going to be used, things like what happens if I pull out a sensor. How is this going to affect it? What happens if I miss a calibration event, how is this going to affect it? So, they know up front what to expect.

MS. KRUGER: Just one more comment.

It would be nice for them to be able to see the trends and graphs that we will be seeing so they know how we are going to be interpreting the data when we get it.

DR. NIPPER: Does the sponsor plan to have an 800 number for people to call for information?

MR. GREGG: This is Terry Gregg.

We currently have a 24 hour 800 number and all of the people that will be answering that for this particular device will be trained as we currently do for insulin infusion pumps.

I would also like to add that to date we have trained over 2,000 certified pump trainers on the MiniMed system and this device would be incorporated into that training and certification.

DR. NIPPER: Thank you.

Dr. Kroll.

DR. KROLL: I would suggest you have a section in the beginning that gives a physiologic background that really stresses to the patient that the patient is going to work with a diabetes care team and they will all work together and that initially start by recalling the benefits of better control of glucose, in other words, decrease complications and fewer incidences of hypoglycemia.

Then I think you should stress that fluctuations are typical for glucose period. And then the second thing is that extreme fluctuations in glucose are typical for people with diabetes and that analyzing the trends can be an aid for the diabetes care team to minimize these extreme values.

DR. NIPPER: Thank you.

Dr. Cooper.

DR. COOPER: No further suggestions.

DR. NIPPER: Dr. Lewis.

DR. LEWIS: Nor I.

DR. NIPPER: Thanks.

Dr. Rej.

DR. REJ: No. There were some excellent suggestions that were made by others.

DR. NIPPER: Thanks.

I have mixed feelings about the patient education device because I know that in brand new diabetics and some people who are not familiar with the disease, you may need to take one approach, but I have a hunch that a lot of the people who are going to be using this device are not brand new diabetics. They are people who already understand the disease pretty well. They may have dealt with educators. In other words, they may be more sophisticated than we think. So, you might want to -- I don't know whether your marketing studies will tell you that when you talk to diabetics, but I am sure that you will be able to pitch the labeling and the instructions appropriately to the audience that needs to read them.

I am particularly worried, though, about the non-diabetologist clinician being able to digest and understand what this device is going to do because all of the physicians that I know these days are extremely busy and I worry that they may not know as much as they need to know in order to use this device effectively. So, I have some concerns there and I will be expressing those in writing to the FDA.

At this point -- yes.

MR. GREGG: If I may address that -- Terry Gregg.

With response to the training issue with regards to physicians, we currently conduct over 70 symposia each year on the education of physicians for the use of insulin infusion pumps. This device is intended to be incorporated into that same type of educational system. It is not intended to be generally available outside of that system with proper training to the entire health care professional staff.

DR. NIPPER: I think you will have a lot of demand for it, though.

Agenda Item: Open Public Session

At this point, the panel has just about exhausted itself. So, I would like the panel to take a brief break because we are going to reopen the public session for a presenter. Dr. Elaine Pass has asked to talk to the panel and to the audience for a minute or two about her experiences. Is Dr. Pass with us? Please come forward. The podium is yours for five minutes.

DR. PASS: My name is Dr. Elaine Pass. I am board certified in family practice, but the main thing I want to say is I am a Type 1 diabetic and this MiniMed instrument would just be so necessary. I practiced for 35 years and 16 of those years, I am a Type 1 diabetic.

What I see is without the -- I want to address the hypoglycemic first and then patient compliance. For me, when I was diagnosed with Type 1, it was 1983. Right from the bat, I just knew that normal control was the way to go, even before the trials. So, you know, I kept my glyco hemoglobin at 6, but the thing is the hypoglycemic awareness completely peters out with time.

As I encouraged myself and my patients to maintain normal glycemia, you have to have some sort of alarm system to tell you when you are slipping into hypoglycemia. For that reason, both to save my life, which is pretty important to me, and for my patients, who also have lost their hypoglycemic awareness with the duration of the diabetes, how could you tell people, you know, have normal control when you know both from personal experience and, you know, to do this, when there is no device like this new device that is on the market that will tell you when you are slipping into hypoglycemia.

For me, I would buy it in a second if I could today, like I wouldn't leave home without it, for sure.

But anyway, part 2 has to do with compliance. Most of my patients are African American. I work in Bushwick-Bed Sty(?) in Brooklyn for 35 years. Straight off the bat, my patients, the ones who, you know, do the finger stick, they just see enormous benefit and when I do it for them, a lot of people say, no, I am too old. I don't want to do it. I don't want to do it. I say, okay, let me do it for you and I show them, you know, how simple it is to prick your finger. The thing is believing. So, if you see your value, you know, is 300 and you know it is not such a good idea, you know, to keep leaving it at that, the compliance increases.

With this device by the MiniMed Corporation, which has nothing to do with it at all, I just don't see any detriment, you know, used under the controlled three day thing. Doctors could read. So, if you label the box, those doctors who are going to, you know, want to use it will. So, for the two reasons, the hypoglycemic alert, which is so mandatory, so mandatory, and compliance, I really, please, please vote yes.

Thank you.

DR. NIPPER: Thank you, Dr. Pass.

Just for the record, Dr. Pass, don't leave. I forgot to do my chairman's job here. I may get fired along with Dr. Rej here. Just for the record state whether you have any interest in the company and whether you own any stock. I think you said that, but I just want to make sure you --

DR. PASS: None whatsoever.

DR. NIPPER: Thank you very much. I appreciate your heartfelt comments.

At this point, I would like to ask if the sponsor has anything they would like to add for the panel as a result of our discussions.

MR. GREGG: Terry Gregg.

Yes, I would like to thank the panel for the rigorous review of the PMA application. I would particularly like to point out that the relationship with FDA and their activity on literally a daily basis and they have been very cooperative throughout the situation as we continued to supply them data, they continued to supply us with responses. And in general, thank you very much.

DR. NIPPER: Thank you very much.

Dr. Gutman, do you or your staff have anything you would like to add?

DR. GUTMAN: I don't. Does anybody from the team? No.

DR. NIPPER: The people that addressed the public session this morning, I don't have that in front of me right now, do those presenters have anything that they would like to add? Okay.

I think I am ready.

MS. LAPPALAINEN: All right. Then we will close the open public session.

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