Tuesday, October 24, 2006

Up front on diabetes research and development

A couple of weeks ago I got a call from my diabetes nurse. She told me that the hospital had started an innovative collaboration with a private company. The “aim” of this collaboration was to develop a sort of a “single use pump”, a device to be put onto the skin to deliver insulin for 3 days, after which it should be replaced. The company was not really into diabetes and insulin treatment, and thus they would like to discuss the features and possibilities of this device with patients and caretakers. Therefore the company had asked the hospital to arrange for a meeting with a host of diabetics, half being pen-users and half being pumpers. If I was interested, I was invited to participate in this meeting. I thought that sounded interesting, and figured that I would be able to make arrangements in order to leave work a little earlier on the day of the meeting, so I accepted the invitation. “Great, you will receive a letter from H (chief physician on the endocrinology ward of the hospital, and apparently consultant for the company on this project) with more information about the meeting”.

The letter informed us that apart from us as patients, the three diabetes nurses that are involved in pumping and H himself would participate in the meeting. Apparently the company, in collaboration with the hospital, had developed a new insulin pump that would go into clinical trials at the hospital next year. As the company was new on this field, without much experience with insulin treatment, they would like diabetics to advise them about views on pumps in general, as well as evaluate their prototype regarding the idea behind the concept, the design, and other wishes or needs in connection to pump treatment. They would want to present the prototype and get a patient to try it. That sure sounded interesting!

Yesterday was the day for the meeting. This was the first meeting in Odense that the company and hospital would host. We were 8 diabetics on pumps, the three nurses, H – attending another meeting simultaneously, and two representatives from the company. H opened the meeting by welcoming the company representatives and us, describing us as part of the elite of diabetics, people who were on top of their diabetes management (nice to know :-) although I am not sure how much insight he actually has on this, as I don’t think that he is a consulting doctor anymore). By the company representatives request we introduced ourselves to them and each other, on camera because they needed to be able to take our opinion back to their engineers. It turned out I was among people, who had been diabetics for as long as 50 years! A few had lived with this disease for 35+ years, one of them having had a pump for more than 20 years (several different types along the way).

When the representatives presented this new “single use insulin pump” to us, they soon learned that some parts of the concept/design was not ideal. We also had to turn our minds into not seeing this new product as an insulin pump in line with the pumps that we use, but rather sort of an insulin pen based infusion-device. It is an oval-shaped, wireless, plastic device with an electronic part that is reused when the “pump” is replaced. It is filled with insulin from an ordinary insulin pen – a very smart feature in my opinion. On its backside it is covered with an adhesive, and to insert the devise, you attach it to your skin, pres a button to introduce the needle into your skin, and remove said button, so that you are left with only this 7.5 x 5 cm (2.95 x 1.97 inches) and about 0.7 cm (0.3 inches) thick oval shaped devise. 20 minutes after insertion the “pump” will start infusion of insulin at a pre-set basal rate. A button on the devise allows you to administer boluses, each press on the button will release 1 U of insulin. The “pump” will continue working until empty, or about 3 days, at which time it will alarm you by vibrations, sound and light, to make you replace it. As you might have guessed by now, said presentation (of which I have only reported the most essential parts) led to quite a few points of criticism and comments. The devise did not enable you to change the basal rate, nor did it allow administration of “odd” numbers of units for boluses. This of course should be seen in the light of the target group of patients for this devise: Diabetics currently on a pen regimen, who may not yet be fit to take the full step into pumping, or who attends a hospital without the economic potential to pay for a pump (in DK, pumps and pumping supplies are financed by the hospital treating the patient) – this devise is supposedly cheaper than regular pumps although, of course, more expensive than traditional pen-treatment, and otherwise might benefit from a “near-pumping” regimen.

I tried the prototype on, without a needle in it, and it was actually surprisingly comfortable to wear, despite its size. I would like to show you a picture of it, but I will refrain from that as I am not sure whether the company has otherwise gone public with their new concept yet – and I wouldn’t want to give their idea away now, would I :-) We all filled a questionnaire about our own way of treating our D as well as our thoughts about the new devise, its advantages and limitations. The company representatives expressed that they had greatly benefited from the meeting, being a bit surprised about our main point of criticism (the lack of the possibility to change the basal rate as needed), and they would take our response into consideration in the ongoing development of the devise.

H returned to close the meeting by handing us another questionnaire, this one being related to his own project on developing a sensor to alarm diabetics about hypoglycaemia – also an interesting project indeed. The nurses handed out envelopes containing a tube to sample blood for an HbA1C and a question about our quality of life before and after the pump. This is for their continual specification on the regulation of pump users. Thus, this was an afternoon of multiple questionnaires as well as a demonstration that the hospital, and especially H, is up front in research and development when it comes to diabetes :-)

2 comments:

Chrissie in Belgium said...

Wow Heidi, H seems really involved with keeping up front on new diabetic trends. I think it is really great that you were involved in the program, but the inability of adjusting basal rates seems to me so elementary. Why didn't they KNOW this was necessary? You spoke of 1U increments - this would definitely not be sufficiently precise/accurate for many diabetics. Maybe this too was mentioned. Anyhow, pls do keep us informed of the progress of this study.

Scott K. Johnson said...

Interesting!

But I also agree that it is strange that they didn't anticipate a need to have basals adjustable to more fine increments than 1 whole units!