SmartCells, Inc. Producing SmartInsulin â„¢: Is This the Future?
Once again, Ann Bartlett gave me a mission: find out about SmartInsulinTM. So, like everyone one else interested in learning about a topic, I used Google and asked a smart 25-year-old who can find information about anything on the internet. After an extensive scholarly search on Google, I was unable to find any preliminary controlled studies conducted on humans. However, information gleaned from Technology Review (Jennifer Chu, October, 2008) notes that Todd Zion, who is the founder and CEO of SmartCells, Inc., developed the technology at MIT where he earned his doctorate in the Nanostructured Materials Lab. According to Chu’s review, Dr. Zion “modified insulin by chemically attaching it to a biodegradable polymer containing sticky sugar groups. He then mixed it in solution with a sugar-binding molecule, which, in the absence of any other sugars, immediately binds to the sugar groups attached to the insulin. As more binding molecules grab on to more modified insulin, a network forms that holds the insulin in place. When glucose is added to the system, it bumps the insulin-bound sticky sugar group out of the way, grabbing on to the sugar-binding molecule.” It therefore stands to reason, that the higher the concentration of glucose, the more insulin is released from the network by dissolving.
By testing the new drug on rodents and “diabetic” pigs in pre-clinical trials, with the use of continuous glucose monitors, they were able to document the amount of insulin released from the network in response to increased glucose concentration secondary to a simulated meal. Apparently, Dr. Zion’s team demonstrated that SmartInsulin TM is able to sense and react to variable glucose concentrations and release insulin as needed. He has even been able to avoid hypoglycemia. It is hypothesized that an injection of SmartInsulinTM will only be required once a day. According to my second source who spoke directly with a company representative, SmartCells, Inc. has not yet published and hopes to be able to publish preliminary results in the next 9 to 12 months. Dr. Zion’s team hopes to begin clinical trials with rat and pig models within the next 18 months. And, unofficially, they have had preliminary talks with the FDA.
The JDRF partnered with SmartCells, Inc, ($1 million grant) to research safety and efficacy studies in these preclinical animal trials. According to JDRF, the partnership is structured to support milestone-based funding through proof of concept human clinical trials. JDRF plans to accelerate the commercial development of SmartInsulinTM. However, keep in mind that no human trials will be conducted until this preliminary data is analyzed and deemed safe.
What are the benefits of SmartInsulinTM? Based on the information available, I see 10 potential major benefits.
- One injection of one kind of insulin per day (with the same needles and potentially an insulin pen that will become commercially available)
- Because of the inherent sensitivity to glucose concentration by the insulin network, there will be considerably less hypoglycemia that is, in my opinion, the most serious stumbling block in insulin adjustments. It appears that SmartInsulinTM may function more like a pancreas in terms of feedback.
- The real possibility of less blood glucose monitoring.
- More flexibility of life style in terms of meals and exercise.
- Decrease in and side effects of oral medications with the use of SmartInsulinTM in patients with T2DM.
- Less expense because there are less medications.
- Less acute and chronic complications of T1 and T2 DM.
- Less anxiety in caregivers (especially those of small children and worries over hypoglycemia).
- Less paperwork for my diabetes team (School forms!)
And more sleep on my nights on call. (smile)
I will continue to surf Scholarly Google and my clinical research journals to keep you posted in regard to new developments and progress with SmartInsulinTM. I know my second source will do so as well. As far as possibilities: keep in mind that the first relatively peakless basal insulin- Glargine (Lantus) was only discovered and developed within the last eight years. Now, Levemir also is available. As a result, basal/bolus therapies continue to flourish along with insulin pump therapy. Much can (and will) change with a new insulin therapy paradigm. R_emember_: INSULIN (no matter what regimen) is the key to treating diabetes until we learn how to prevent or delay its onset.
Fran Cogen, M.D., C.D.E., is the director of the Childhood and Adolescent Diabetes Program at Children’s National Health System. She wrote about diabetes for HealthCentral.