JDRF has launched an online service to connect folks with type 1 diabetes to clinical trials related to type 1.
The JDRF Clinical Trials Connection site gives you an opportunity to participate in trials that may lead to better treatments for type 1 diabetes. I know from participating in clinical trials at the Joslin Diabetes Center and for Dr. Faustman that many of these trials have problems recruiting qualified individuals.
According to the press release I received: "people can provide criteria like the type of trial they are interested in, how long they have had diabetes, and how far theyd be willing to travel, and the site will let them know about studies that match those characteristics. Clinical Trials Connection can help them search for trials, compare one trial with another, and update them on new trials that might match their interest. Plus, the service provides contact information for the researchers conducting the trial, so people interested in trials can contact them directly for more information, after discussing options with their healthcare provider."
The site also includes the following public service announcement ad about clinical trials.
Initial registration at the clinical trials site requires your name, email address and date of birth. After getting your password by email, you then enter much more details including: your date of birth (again); whether you or a family member has type 1 diabetes; date of diagnosis; address; states you would travel to for trials and other details.
I registered and the search for trials turned up the following five:
Study of Islet Transplantation in Type 1 Diabetic Kidney Transplant Recipients
Comparison of Lantus and NPH Insulin in the Dawn Phenomenon
Closed-Loop Glucose Control for Automated Management of Type 1 Diabetes
Imaging Inflammation in Autoimmune Diabetes
Glycemic Stability of Insulin Aspart Versus Insulin Lispro in Insulin Pump Therapy
For each of these studies they provide a more detailed description including: eligibility; exclusion criteria; the clinical phase of the trial; location and contact details.
What have you got to lose? I'd strongly recommend registering so that you can move the state of diabetes research forward.
The New England Journal of Medicine has just published a paper on a JDRF-funded study showing how continuous glucose monitors impacted blood glucose control.
The study proved that CGM's resulted in better blood sugar control for people over 25. Hopefully this paper will be useful in supporting insurance claims for coverage of CGM devices. Maybe you'd like to send a copy(PDF) to your insurance company when you make a claim for CGM coverage.
I'm excited that this independent study of a relatively large number of people showed such good results. A few more like this, and it will be hard for companies to argue that CGM's are experimental devices. Dexcom summarized the paper like this:
Highlights of the study results include: -- Patients 25 years of age or older who used CGM showed significant improvement in glucose control as measured by HbA1c. -- Most importantly, this improvement in control was observed without an increase in hypoglycemia (low blood sugar), which is a common concern in intensively managed patients trying to achieve improved glucose control. -- In all ages, patients who used CGM at least six days a week had substantially improved HbA1c levels.
In addition to successfully meeting statistical significance for the primary endpoint of absolute A1c reduction, the adult cohort in the study patients 25 to 72 years old also successfully met all secondary endpoints with statistical significance (including A1c of less than 7.0 percent, A1c of less than 7.0 percent with no severe hypoglycemia, greater than 10.0 percent relative reduction in A1c and greater than 0.5 percent absolute reduction in A1c).
Younger patient populations did not see a statistically significant reduction in A1c. However, patients in those study arms used the Personal CGM device less often than prescribed (50 percent of the time or less). All patients, regardless of their age, experienced A1c reductions when they used the device at least six days a week. The most compliant study arm adults 25 to 72 years old used the device more than 85 percent of the time and subsequently saw the greatest improvement in A1c. These findings expand upon the results of previous studies like the Star 1 Study demonstrating that more consistent use of Personal CGM results in more significant reductions in A1c.
The trials sound very interesting and it looks like they've made a lot of progress. It's also good to see the interest in diabetes that has been generated due to the artificial pancreas project.
This is because of the recent NIH, FDA, and JDRF 2-day collaborative workshop on the Artificial Pancreas. The sessions were recorded. You can see the video for day one here, and for day two here.
The agencies and people involved seem to be taking a very pragmatic approach to combining the individual technology pieces to this puzzle. All of the required pieces of hardware already exist, the hard part is getting the software to work so that insulin and blood glucose controls can be automatically controlled. Thankfully those involved seem to be working to get a solution that's usable rather than a 'perfect' device. Hopefully the early prototypes will quickly inform folks about ways in which the overall approach can be improved.
The CBS piece mentions that the artificial pancreas may be available in 5 to 10 years.Because of approval and regulatory issues, I would guess this is closer to 10 years out. I hope it's a lot sooner than that.
They're working on developing a closed loop system where readings from a continuous glucose monitor (CGM) are used to directly control an insulin pump. Currently those of us with CGMs and insulin pumps have got an open loop system, we need to take the readings from the CGM and decide whether we need insulin or food.
Clearly this is a difficult problem to solve. How would such a system know if you were sick? What would it do when you're about to exercise? How would it handle changing insulin needs for children who are growing?
Now you have a chance to learn more about this project. On July 21st and 22nd the FDA, NIH and JDRF are holding a public workshop 'focused upon the state of the art in the research and development of an artificial pancreas'.
The meeting will be in Bethesda Maryland at the NIH campus. Building 38A on this map. Space is limited so you do need to register.
I would love to go to this workshop, but I'll be out of the country.
Can I ask you a favor? If you go the workshop can you write up a summary of what's discussed and post it to the blogosphere?
Attribution: The illustration above is from the JDRF site.
PARADE Magazine (which comes in some Sunday newspapers) is holding this contest where the 8 charities that attract the most individual donations will receive $50,000 and be featured in PARADE magazine article. This is a great opportunity to raise visibility for diabetes research.
To help you donate to JDRF through the Network for Good organization. Your donation can be of any size. You'll have to register with Network for Good to do this (I just did) and then you can donate via Paypal or with a credit card.
To me, this seems like a relatively inexpensive way to raise awareness of the importance of diabetes research and the search for a cure. I hope you'll agree because right now JDRF is not even on the top 10 list for this contest.
I've had type 1 diabetes for a long time and I've spent much of that time hoping for, and thinking about, a possible cure for diabetes. But I'm also very interested in the research that JDRF is doing on an artificial pancreas.
I can understand how a closed loop between a continuous glucose monitoring system and an insulin pump could work to control my basal (background insulin) rate. But I really didn't see how it might also be possible to effectively give boluses (larger doses for meals or BG correction) with such a system.
Yesterday I stumbled across a short paper in Diabetes Care, Detection of a Meal using CGM. The authors describe a Meal Detection Algorithm that allows them to detect a meal about 30 minutes after the person has started eating!
It's not perfect - but we already know that's true for most of diabetes care. Uf this brings the Artificial Pancreas a little closer and make diabetes treatment a little easier, I'll take it.
Insulin is not a cure. But automatic insulin delivery is a step in the right direction.
Update: There will be a workshop with updates from the artificial pancreas project in late July 2008.
I came across a report from the BBC about work on an artificial pancreas in Cambridge, England.
Apparently trials are currently being done on 12 children aged from 5 to 18. The work involves a continuous glucose monitor that's fitted under the skin, though it's not clear who makes this.
The research is led by Dr. Roman Hovorka, and it seems as if they're making real progress. I also came across slides and audio for a presentation that he gave.
This is all part of the artificial pancreas project being led by JDRF. Sounds like this project will lead to some interesting treatment options.
The Diabetes Technology Blog is focused on using technology to life better with diabetes. I review: blood glucose monitors; continuous glucose monitor; blood sugar meters; diabetes software and living with diabetes.
About Me
Name: Bernard Farrell
Location: Massachusetts, United States
I was born in Ireland and now live in the US.
I have had Type 1 diabetes for over 36 years. I struggle with my blood sugar, the same as most people with diabetes.
I wear a Cozmo 1800 insulin pump and a Dexcom SEVEN Plus CGM to track my blood glucose levels.
I'm blessed by God, and every day brings the possibility of a cure.
They're working on developing a 
