Team:ShanghaiTech China/Human Practices
Questionnaire
We received 670 valid questionnaires in total from almost every province in China through the internet. The questionnaire is about public awareness and related life experience of Diabetes Mellitus Type 2 (T2D). The results are shown in the following diagrams.
Questionnaires' Geographical Distribution
Questionnaires cover most provinces in China. The results of the questionnaire can be considered valid because of its distribution.
Furthermore, some patients mentioned their worries about the side effects and the dependence on drugs. Some of the patients were not satisfied with the treatment effect. Also, some of the patients are unlikely to adhere to treatment.
According to the questionnaire feedback, the public is keen to try new bacteria drugs for T2D.
Summary
T2D Patients are mainly the elderly. However, it becomes more common in younger ages due to a changed lifestyle. And patients have some dissatisfaction with the current treatment. For example, patients mentioned their concerns about high costs for drugs and missing insulin injection several times may lead to some consequences.
Ideally, our treatment of the intestinal bacteria can solve most of the pain points of current treatments. In our project, patients only need to take some drugs orally for a short time. And they can obtain a long-term effect. Also, we can avoid injection pain completely. We expect our project’s cost for each patient will be lower than the current methods in a long period, which may be more economical for patients.
The public understanding of type 2 diabetes is still not deep. There are concerns and expectations for the treatment of intestinal bacteria. Interestingly, about half of the people are willing to try the new method, which inspires us to continue our project.
Industry Practice in Pharmaceutical Enterprises
During the summer vacation, we visited some of the famous pharmaceutical enterprises, with the help of ShanghaiTech University. We visited Novartis and Hedu enterprises, and talked about our idea of treating T2D with the experts. Dr. Zhengtian Yu from Novartis and Dr. Bin Xiang from Hedu gave us a lot of advice about our idea. They all emphasized the prospect and importance of bacterial drugs in drug development and gave some examples of bacteria drug developing in the laboratory. Dr. Zhengtian Yu told us many advantages of the bacteria drug, due to the progress of gene-editing technology, such as low cost, easy assembly, long-term effect, and regulable module. Dr. Bin Xiang shared the development of modified bacteria which was aimed to fight cancer. He reminded us that it was important for us to consider the strict regulation of expression level of modified bacteria when it was the case for T2D, while there was no need to regulate the expression level of modified bacteria against cancer. The expression level of modified bacteria must be regulated carefully to meet with changes in the patient's blood sugar level. Therefore, according to the advice provided by two doctors, we started to think about regulating the expression of modified bacteria intelligently. In this case, we found a suitable light-inducible system for our project, which is pDawn.
Dr. Bin Xiang sharing the development of bacteria drug
Interview with doctors and expert scientists
Doctors
We got feedback from Dr. Junfeng Han and Dr. Yin Yang, two doctors from Shanghai Sixth People’s Hospital.
First, we learned that T2D patients are further classified into two types. In the first type, the baseline blood sugar is at the normal level. However, after meals, their blood sugar will rise above the normal level largely. In the second type, even the patients do not eat, the baseline blood sugar value is much higher than the normal level. In the original design of our project, we only considered the 1st type of T2D patients. After learning the 2nd type, we changed our system to fit both two kinds of situations. We added an On/Off button in the control App so that the patients can manually turn it on before meals before the rise of blood sugar levels. And for the 2nd type, patients can turn it on for a longer period time to decrease the baseline sugar blood.
We also learned some general treatments from doctors. For the patients of the first type, doctors usually prescribe some oral medication or insulin. For the patients of for the second type, the doctors will usually prescribe long-acting insulin and sustained-release tablets or controlled-release tablets. In the questionnaire, we have learned that our project may solve some of the pain points caused by current treatments such as long-term acting.
Dc. Yang
In terms of measuring blood sugar, we learned from doctors that there are other methods besides measuring sugar directly from blood samples. There are techniques to measure blood sugar levels indirectly through measuring saliva and interstitial fluid, which are also reliable.
In our original design, we wanted to measure blood sugar directly from blood. With feedback from doctors, we changed to measure saliva or interstitial fluid. This update can greatly improve the user experience and comfort.
Doctors mentioned that bacterial drugs are high accepted by patients. There are developed bacterial drugs like bifidobacteria for stomach problems and they have been widely used. Therefore, we do not have to worry about patients’ acceptance.
The doctors also brought us some important points for future experiments.
1. Our engineered bacteria should not adversely affect existing bacteria.
2. When the intestinal flora acts, many bacteria work together instead of a single strain at work. Our engineered bacteria cannot affect the interaction between current intestinal bacteria species.
3. A lot of experiments are needed to determine when to release the drug.
4. We need to guarantee the safety and effectiveness of the kill switch.
Expert scientists
We talked about the lighting module with Dr. Yuqian Ma form the University of Science and Technology of China, who is an expert in the field.
In the original plan, we were hoping to use blue light to control our system. But after the discussion with Professor Dr. Ma, we were aware that the wavelength of blue light is too short to penetrate the human skin and reach the intestinal canal, hence it is almost impossible to use blue light as the controlling signal. Thus, after consultation and deep desktop research, we decided to use infrared light to penetrate the human skin, and by using upconversion nanoparticles, we can convert the infrared light into blue light inside the intestine and results in the blue light reaching the intestinal canal.
The photothermal effect of infrared light is very strong. Therefore, Dr. Ma suggested applying some cooling methods. Then we tried to add cooling pads to our device to solve this problem.
We discussed the intensity of light with the researcher. To ensure the safety of the light module, he pointed out that the intensity of light should not be higher than 400 mW/cm2.
We also interviewed Professor Wei Qi from ShanghaiTech University who’s working on pharmaceutical research. In our original design, we constructed agarose vesicles that specially serves as a bacterial carrier. Though agarose vesicles can help our bacteria stay in the digestive tract, it cannot ensure all our bacteria are exactly released in the intestinal canal. Professor Qi pointed out enteric-coated capsule material may be available, which allows our bacteria to be released in the intestinal canal. After finding out more information, we decide to apply the enteric-coated capsule. This improvement makes our drug much more efficient.
Prof. Qi
User experience
We invited some volunteers to wear INSULEN Waist Pack and hoped to polish our design based their advice. They highly appreciated of our Waist Pack about its portability and practicality. The temperature of light and battery also attracted their attention. According to their feedback, we added Silica gel cooler cost 1$ to our Waist Pack so that greatly reduce the heat exposure to users. Moreover, we used special black tape to wrap the red light to avoid stimulate the human eyes and keep the effectiveness to control light-induced promoter.
Volunteers
Roadshow
We plan to have a roadshow on October 25th when the wiki has been frozen. Therefore, more details will be shown on our final display. During the roadshow, we are going to test both the concepts of our idea and hardware among the audience. We expect we will improve more with the feedback gained from the roadshow.
Introduction for Public Engagement
That’s the effort we made for the perfection of our target users’ needs. The repetitive consultation and gathering questionnaires enable us to get a closer look at what the patients truly need and ultimately reach what we have today. During this process, we realized how inspiring iGEM is, so we also did a lot to popularize synthetic biology and iGEM, to make those inspiring concepts available for more people. The game we designed, cartoon video and held some education activities we made are only the merest effort we made to fulfill that goal. The hyperlink of our work on that is shown below:
https://2019.igem.org/Team:ShanghaiTech_China/Public_Engagement