Better lancing devices: A press release
October 26, 2004, from
Pelikan Technologies describes a lancing device that
would be "the first fully-automated, electronically-controlled,
self-contained system that allows a patient to execute the entire
lancing process at the touch of a button. Lancing, an often
painful act of piercing the skin in order to obtain a sample of
blood for glucose measurement, is required multiple times each day
for millions of people with diabetes. Pelikan’s innovative
technology significantly reduces that pain and allows people with
diabetes to more easily obtain a blood sample." This product is
expected to be launched in the spring of 2005.
Insulin patches: There's a very interesting
webpage about this topic on the Internet: it's posted by
an Israeli teenager, David Rubinstein: "My name is david and i'm
15 years old and 4 years Juvenile diabetic. This system was
invented by my father who have many international patents in the
drug delivery systems field and who dedicated all his time as well
as his staff time to the development of this system. Today the
final development of this patented system had some financial
problems and I hope my father will find the way to overcome them.
After overcoming this problem, the patch can be available in 2
more years..."
Pills for Type 1 diabetes:
Acarbose (Precose™) might help a bit in theory, but it
turns out that it really doesn't do much; insulin's still needed,
of course. (Acarbose has been approved by the U.S. FDA for use in
Type 2 patients.)
Buccal (cheek) delivery of insulin: A
press release dated July 14, 1998, from a Canadian
company, Generex, discusses "the Company's oral insulin
formulation," Oralin, but closer reading indicates it uses a
"Metered Dosage Aerosol Applicator". See a more recent webpage
about
Oralin (http://www.generex.com/nav-noflash/04_oralin_frame.html)
from Generex, which states in part: "Oralin is Generex's
proprietary insulin formulation, specially engineered to be
administered in a convenient new way. The Oralin formulation is
delivered directly into the mouth via our RapidMist device, where
it's rapidly absorbed into the bloodstream through the buccal
mucosa. Oralin is designed to be used in the treatment of both
type 1 and type 2 diabetes. People with diabetes can continue to
self-administer the insulin doses they need to manage their blood
glucose levels — but without needles and without pain." (Updated
July 1, 2001).
Islet cell transplants: They work to control
the blood sugar, and many research centers are working on making
them even easier, but many people think the anti-rejection
medications are worse than having diabetes! (Of course,
pancreas partial transplants have been available for
several years. They suffer from the same drawback as mentioned for
islet cell transplants: the problem of rejection of the
transplanted pancreatic tissue.)
Minimally-invasive blood sugar testing:
MiniMed has submitted FDA Notification on a Continuous
Glucose Sensor For Diabetes: "MiniMed's sensor is designed to be
inserted into the subcutaneous tissue, usually in the abdominal
area, utilizing a soft cannula type device. The physician
diagnostic device is to be worn by a patient for three days to
gather and store continuous glucose readings that can then be
downloaded to a personal computer for analysis. The hypoglycemia
alert alarms when the patient's glucose level drops below the
limit established by the administering physician. These devices
measure glucose levels every 10 seconds and record averages over
five minute intervals. After obtaining additional clinical
experience with its initial products, MiniMed anticipates filing
for FDA clearance for a third system for consumer monitoring which
would be designed to replace traditional glucose meters and
strips."
Inhaled insulin, by aerosol delivery device:
For additional information, see
Inhaled Insulin for updated information.
Two abstracts*
(which appear to have been written by the same person!) were
presented on June 16, 1998 at the of the
58th Scientific Sessions of the American Diabetes
Association. The
first was entitled "Treatment of Type 2 Diabetes Mellitus
With Inhaled Human Insulin: A 3-Month, Multicenter Trial" It was
by William T. Cefalu, et al. In it, the authors comment:
"...INH [inhaled insulin] was very well tolerated...
Satisfaction questionnaire results favored INH, and 92% of INH
patients opted for 1-yr extension of INH therapy. We conclude
that anI [insulin] regimen using INH represents a well tolerated
and comparably effective alternative to a conventional regimen
using regular SC I [subcutaneous injections of insulin] in
management of NIDDM, and that INH is liked by patients."
The second
abstract, also presented on June 16, was entitled
"Treatment of Type 1 Diabetes Mellitus With Inhaled Human Insulin:
A 3-Month, Multicenter Trial." Its lead author was Jay S. Skyler.
The abstract states:
"A new dry powder I formulation and aerosol delivery device
permits reproducible pulmonary delivery of rapid-acting I in
therapeutic amounts with 1-2 inhalations per dose. To compare
the safety and efficacy of a regimen using this inhaled I (INH)
vs. a conventional injection regimen (SC), 70 patients with type
1 diabetes (IDDM) from 10 study sites were randomized, after a
1-mo run-in period, to either INH or SC (n=35 ea) treatment for
3 mo. SC continued their pre-study I regimen (2-3
injections/day), while INH received pre-meal INH plus a bedtime
Ultralente I injection... INH was very well tolerated...
Satisfaction questionnaire results favored INH, and 80% of INH
patients opted for 1-yr extension of INH therapy. We conclude
that an I regimen using INH offers a well tolerated and
comparably effective alternative to a conventional regimen using
regular SC I in management of IDDM, and that INH is liked by
patients."
* The information presented in "abstract
form," as these brief medical papers are called, is often somewhat
sketchy, and less scientifically critiqued, compared to reports
that are published as scientific articles in medical journals. The
process of publication of a paper as a scientific article is
subject to thevery time-consuming process of being thoroughly
peer-reviewed, and can take months or years. Thus, abstracts are a
way to present new information rapidly. The information presented
in abstract form is usually considered as being probably valid;
frequently, publication of the same information occurs in
expanded, peer-reviewed form a few months or years later.
In an article in the Kansas City Star on June 17, by Thomas H
Maugh II of the Los Angeles Times, he indicates that "the new
system [was] developed by Inhaled [sic] Therapeutic Systems of San
Carlos, California" (see
below). Mr. Maugh also states "people intrested in
participating in the study can volunteer by calling (800) 438-1985
(which is Pfizer Medical Information, and is answered between
8:45 AM and 5 PM, Monday - Friday, Eastern Time). (Information
added to the Diabetes Monitor on June 17, 1998).
There's a recent announcement (1997) from
Inhale Therapeutic Systems that "Pfizer announces at
Analyst Meeting that pulmonary insulin is providing virtually
identical control to subcutaneous injection in three-month trials
with Type I and Type II diabetics." According to ITS, Pfizer and
ITS are in Phase II trials of using inhaled insulin. (as of
January, 1998). (It appears that the two trials announced above
are those mentioned in this earlier press release. June 17, 1998)
Inhaled insulin, by nasal spray:
It's been tried, but half the patients didn't want to stay on
it during a three-month study that was published a few years ago.
Another company is trying again: in an October, 2004
press release, Bentley Pharmaceuticals, Inc. discussed an
exploratory Phase I study to examine Bentley’s intranasal insulin
formulation; it demonstrated rapid onset of action and appropriate
duration of action for potential use, but there's little
information on how well it was tolerated (except a very broad
statement that it was "generally well tolerated").
Protected insertion of living islands of Langerhans
tissue:
Islet Sheet Medical is working on a "thin sheet
bio-artificial pancreas containing islets of Langerhans for
treatment of insulin-requiring diabetes... Like other
bio-artificial devices, ISM's bio-artificial pancreas is a hybrid
of living cells (insulin-producing islets of Langerhans) and a
polymer matrix coating that protects the living cells. It responds
to changes in blood sugar by secreting hormones just like the
native pancreas. It will normalize blood sugars using normal
physiology and will eliminate the vascular complications of
diabetes. Life expectancy for diabetics so treated will increase
to nearly that of nondiabetics and the cost of health care of
treated diabetics will decrease..." That's a lot of hype for a
product that hasn't yet been tried in humans, but the concept is
certainly intriguing. (May 29, 1998.)
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