1. Introduction
Light-controlled switch regulation of gene expression is an important tool in synthetic
biology, targeted therapies for diseases, and other fields (Renzl et al., 2020; Younas et al., 2023). The blue light-dependent CRY2/CIB1 switch, which is highly promising in the field of
optogenetics, has many applications, including targeted therapies for diseases such as cancer and
malignant conditions (Zhao et al., 2020). Simultaneously, we have found that this technology is also highly suitable for
precision
treatment of diabetes. Therefore, after comparing the common traditional diabetes treatment methods
currently available on the market, we have decided to utilize this technology to develop more advanced
treatment solutions (Brinkmann, 2023; James et al., 2023; Nkonge et al., 2023). In order to better design our product to meet current market demands and address any
technical shortcomings for improved effectiveness, we anticipate conducting a series of human practices
(HP) and integrated human practices (IHP) activities, including market research, social surveys, expert
interviews, and business plan simulations. Through these activities, we hope to gain insights into the
current status and needs of the diabetic patient population and promote our product and synthetic
biology technology to the public in a targeted manner. Additionally, we plan to adjust our experimental
design and product based on expert opinions.
2. Survey
Before attempting to promote our product, we hope to understand the current level of
public
knowledge about diabetes and the current prevalence of the disease. First, by gathering data on the
prevalence of diabetes, we can better understand the impact of diabetes on public health and assess the
potential benefits our technology could bring to society. Secondly, understanding the attitudes and
awareness of the general public regarding diabetes and its treatment can assist us in designing
subsequent promotional and educational activities, which will be instrumental in planning IHP
activities.
2.1 Questionnaires
To achieve the above purpose and answer the two questions " How does the real world
need
our technology?" and "What is the real-world impact of our technology?", we have designed an online
survey using the WJX (a free Chinese online survey platform). This survey primarily focuses on diabetes
disease classification and treatment awareness, as well as the current prevalence of the condition.
Specifically, we asked participants the following questions: "Are you familiar with diabetes?", "How
many main types of diabetes are there?", "Can diabetes be cured?", "What are the common conventional
methods for treating diabetes?", and "Do you have diabetes?"
2.1.1 Characteristics of the Questionnaire
Below are the responses from our public survey in Figure 1&2, which included 522 participants. The respondents consisted of 42.72% males and 57.28%
females. The age distribution of respondents was as follows: 25.67% were aged 0 to 18 years old, 18.58%
were between 18 and 30 years old, 29.31% were between 30 and 45 years old, 23.52% were between 45 and 60
years old, and 2.87% were over 60 years old.
(Figure
1 & 2
. Baseline characteristics of the questionnaire)
2.1.2 Important results
(1) 7.85% of respondents claimed to have no understanding of diabetes at all. On the
other
hand, 53.64% of respondents had a basic understanding of diabetes concepts, while 19.73% demonstrated an
understanding of basic concepts and principles of diabetes.
(2) 17.43% of respondents showed comprehension of basic concepts, principles, and
treatments of diabetes. A mere 1.34% of respondents claimed to have a complete understanding of
diabetes.
(3) A significant amount of the population (68.8%) is diabetic.
(Figure 3
a-d
. Main results of the questionnaire)
2.1.3 Reflections
Through this survey, we have found that the current prevalence of diabetes among the
population is relatively high, although this rate is somewhat biased due to our non-completely random
sampling, which affects its representativeness. However, overall, diabetes poses a significant and
widespread threat to the population. Efficient and cost-effective solutions to address the diabetes
problem have significant public health implications for promoting the health of our country and even the
global population.
Our survey also revealed that despite the severity of the current diabetes epidemic,
there
is still a gap between people's awareness and the level of importance they attach to diabetes,
considering its high prevalence. People have a conceptual understanding and awareness of diabetes, but
they lack a deeper understanding of its mechanisms and treatment options. Therefore, it is essential to
conduct appropriate promotional and educational activities to foster a positive attitude toward health
in society.
3. Interviews and visit
3.1 Interview with experts
3.1.1 Dr Tingting Zhou
Dr Tingting Zhou is an associate professor at Wuxi Medical College of Jiangnan
University.
Through this interview, we were mainly interested in finding out the admissions of diabetic patients,
the main treatments and costs in diabetic hospitals, and learning about the mainstream treatments for
diabetes. Through the method of expert consultation, we were able to gather more frontline treatments
and their costs. Comparing this data with our products allows us to make appropriate adjustments to the
production of our products and technologies, etc.
(Figure 4. Interview with Dr Tingting Zhou)
We gathered a few important points of data through the interview:
(1) Diabetic patient consultations
(a) China has 9.7% of the world's diabetes population.
(b) The number of people with diabetes has been increasing
(2) Treatment of Diabetes
(a) Patients with mild early diabetes can control their blood sugar with
medication
(b) Severe patients need a combination of drugs
(c) Commonly used treatments include insulin injections and oral
medications
(d) Innovative treatments such as new drug targets and gut flora modulation have been
proposed.
(e) Neither treatment can completely cure the patient, but can only control the
disease.
(3) The cost of diabetes treatment
(a) For pre-diabetes or mild treatment, the cost will not be very high, prescribing
metformin oral medication for just over a hundred a month
(b) For severe diabetes, they need a combination of multiple medications, and then the
cost
will be high, several thousand dollars.
(4) Preventive Measures for Diabetes Mellitus
(a) The general public is advised to maintain a healthy lifestyle smoking and obesity
are
important factors leading to diabetes. We need to be active in self-management, including dietary
control, exercise regular monitoring of blood glucose, etc.
(b) Pre-diabetic patients are advised to do regular checkups and monitoring
Reflections:
Currently, in a global context, China has a very high proportion of diabetes patients,
and
their treatment methods typically revolve around promoting insulin secretion or addressing insulin
resistance, which are relatively conventional approaches. Therefore, healthcare institutions are now
seeking more efficient treatment methods, with combination therapy drugs being a current research focus.
However, the cost of combination therapy drugs is a deterrent for many individuals. Besides medication,
lifestyle interventions are also effective measures in the management of diabetes. However, compliance
with lifestyle interventions is often poor, making medications the preferred choice. Therefore, the
current research emphasis and challenges lie in developing combination therapy drugs that are both
cost-effective and highly efficacious.
3.1.2 Dr Zhiwei Zhao
Dr Zhiwei Zhao is an assistant researcher at the Institute of Plant Physiology and
Ecology
Centre of Excellence for Innovation in Molecular Plant Science of the Chinese Academy of Sciences. His
main research interests include plant engineering as well as optogenetic therapy. The interview focused
on the use of optogenetics in the treatment of diabetes and its future prospects. Through this
interview, we gained a deeper understanding of the advantages and disadvantages of blue light-dependent
switch therapy and its treatment methods.
(Figure 5. Interview with Dr Zhiwei Zhao)
(1) Advantage:
The advantages of the blue light-dependent switch genetics treatment method over the
traditional treatment method are that he will be (a) more targeted, have fewer side effects, be more
precise, and can be timed and dosed. For example, it can be treated precisely according to a specific
value obtained in the body. (b) Optogenetic modulation is very rapid, which means that the treatment
time can be shortened. The principle is that the reaction speed of the blue light receptor is extremely
rapid, in the plant body generally irradiated five minutes later, the protein will immediately respond
to the light, and then play a role in being degraded away.
(2) Disadvantages:
(a) There are limitations in the audience, for type 2's there may be basically no
problem
with their insulin secretion, type 1 his insulin synthesis can be solved normally with this kind of
treatment if there is a problem, but if it is caused by some other reasons then there is a possibility
that this is not applicable. (b) Realization of this treatment needs to go through many aspects of the
PR, such as the most basic one of the switches of a provision, his overall investment is certainly very
high in the insulin and pancreas in the treatment of diabetes.
Reflections:
The blue-light gene therapy approach is an efficient, highly targeted, low-side-effect,
more precise, and controllable treatment method. When effectively utilized, it undoubtedly represents
excellent news for patients with abnormal insulin secretion. However, this technology's target is based
on controlling insulin secretion from pancreatic beta cells to regulate blood sugar. This implies that
type 2 diabetes, which operates on insulin resistance as its mechanism, may not benefit from this
approach, even though it constitutes a significant portion of diabetes cases. Addressing this issue and
combining "switch" therapy with conventional insulin resistance treatments could be of vital importance
for the broad treatment of all types of diabetes.
3.1.3 Dr Yang Zhou
Zhou Yang has several research achievements which are highly relevant to our research.
He
developed a novel optogenetic tool that is small, highly sensitive, and efficient in induction, laying
the foundation for optogenetics-based gene therapy and cell therapy. He successfully applied REDMAP in
transgenic expression, regulation of intracellular signalling pathways, control of epigenomic
remodelling
, and long-term transgenic control in animals using Adeno-Associated Virus (AAV)
delivery,
as well as regulation of insulin expression in diabetes treatment.
(Figure 6. Interview with Dr Yang Zhou)
Dr Yang Zhou believes that AAV is a relatively simple single-stranded DNA virus with
high
infectivity and safety. AAV cannot replicate on its own and relies on other viruses such as adenoviruses
and herpesviruses. It is used for optogenetic gene expression, allowing gene expression to be controlled
through light stimulation. Currently, AAV has been widely applied in the field of optogenetics for the
treatment of diseases like diabetes and obesity. Additionally, AAV can be used in gene editing, cytokine
therapy, and other areas.
The advantages of red-light technology include the absence of the need for frequent
injections or medication, making it a non-invasive method. However, red light receptors currently exist
only in cyanobacteria and plants, making them temporarily unsuitable for use in humans. Blue-light
receptors have a broader range and higher efficiency, but they have weaker penetration of human skin.
Selecting the appropriate wavelength for regulation is also a consideration. Finally, by choosing
specific wavelengths of light to regulate different areas, more precise treatment methods can be
achieved.
Two major challenges of this approach are the safety and efficiency of host cells,
which
will be the focus of future research. We did not use chemical methods but directly introduced insulin to
lower blood sugar levels. Metformin can be used as a control drug and combined with various technologies
such as gene delivery and cell modification. Regarding environmental issues, this technology may be
applied to humans in the future, but it will require time and technological improvements. We mainly
discussed how to transfer the insulin gene into artificial cells to enhance its efficacy and prolong its
duration of action. Although insulin has always been present in the human body, there are risks
associated with prolonging its duration of action or rendering it ineffective, which could lead to
adverse reactions such as hypoglycaemia. Therefore, researching how to use genetic engineering to make
insulin act more persistently and safely in the human body is crucial. With genetic engineering
technology, insulin can be expressed when needed and self-consumed. Using AAV vectors can regulate
insulin secretion without altering the insulin gene, thereby avoiding issues like
hypoglycaemia.
Reflections:
Through the interview with
Dr
Zhou, we have gained a further understanding of the application and prospects of
optogenetics in the treatment of diabetes. In this interview, we compared the blue-light therapy
currently being conducted with the red-light therapy researched by Dr Zhou. The advantages and
disadvantages of blue light-dependent switch therapy have also become clearer. Additionally, Dr Zhou
introduced to us the functions and applications of AAV vectors, which may help our research take a big
step forward.
3.1.4
Professor
Chunhua Qian
Professor Chunhua Qian, female, Department of Endocrinology, Shanghai Tenth People's
Hospital, Associate Chief Physician, Doctor, Master Supervisor. She is good at scientific research and
clinical treatment of diabetes, obesity, Thyroid disease and osteoporosis. She has undertaken multiple
projects from the National Natural Science Foundation of China and the Shanghai Municipal Health
Commission and has published multiple papers. She is currently a member of the Neurology and
Endocrinology Group of the Chinese Medical Association, a young member of the Endocrine Branch of the
Shanghai Medical Association, and a young member of the Osteoporosis Special Branch of the Shanghai
Medical Association.
(Figure 7
a&b
. Interview with <
professor
Chunhua Qian)
We interviewed
Professor
Chunhua Qian to learn about the major problems and needs that diabetic patients
are
currently facing. Explore the effectiveness and limitations of existing treatment options for patients.
Combined with the results of our previous investigations and interviews on diabetes and related blue
light therapy techniques, Professor Qian could provide us with more integrated scientific and clinical
expertise and feedback on our design.
Professor
Qian believes Type 1 diabetes cannot be cured because it leaves the patient with
a
complete lack of insulin. Pancreas transplants and stem cell transplants have been experimented with but
found to be unworkable. Targeted regulation of the transplanted cells is not currently possible and
rejection occurs. There are different treatments for different complications. For obese patients’
metabolic surgery will be used and regulated by diet. Patients who are pregnant cannot be treated with
insulin because the health of the baby inside the patient has to be taken care of. Light therapy is
currently used only in the rehabilitation phase of patients, it has not been established that light has
no definite efficacy.
3.2 Visit the National Metabolic Management Centre
After the interview with
Professor
Qian, she led us on a visit to the National Metabolic Management
Centr
e
. During the visit,
Professor
Qian also emphasized all treatments, medications and traumatizing treatments are
in
the last order of priority, and the first thing to consider is to improve the diet, physical activity
and lifestyle. She also briefed us on the current status of research in their lab, emphasized the
famous
saying that "the superior doctor treats the unhealthy" and encouraged the team members to pursue a
career in the medical profession.
(Figure 8
a-d
. Visit the National Metabolic Management Centre)
Currently, they are researching the use of high-pressure injection of drugs, more
commonly
known as the use of high pressure to make the drug penetrate the skin into the body, but the efficiency
has not yet reached the desired results. In addition, the research and development of oral insulin has
reached the final stage of experimentation, and will soon be available, then you can painlessly ingest
insulin. The more obvious and traditional symptoms of diabetes are dry mouth, excessive drinking,
excessive urination, and weight loss. However, the onset of symptoms is now more abundant, which
includes weakness, sudden heart attack, sudden brain attack and other phenomena.
Reflections:
After the interview and visit, we divided all the ideas briefly into food treatments as
well as other treatments, specifically (1) Diet: The benefits of a scientific diet for the patient
include reducing the burden on the pancreatic islets, correcting metabolic disorders, controlling weight
within a reasonable range, and controlling blood glucose within a reasonable range. (2) Other attempts:
A pulmonary inhalation insulin delivery system has been tried, but failed due to the absorption of the
drug by the mucous membranes, resulting in a failure in the efficiency of drug delivery. The nation's
lack of attention to physical health has instead focused more on the cost of treatment and monitoring.
Diet is the key: monitoring is the guarantee; exercise is the means; education is the core; and
medication is the weapon.
4. Pitch
After conducting preliminary research through surveys and interviews to understand the
potential of blue light-dependent switch therapy and its safety considerations, we performed an initial
business analysis of the product and drafted a business plan. We presented our business plan to
professional business investors
, Mr. Kong Yunjie who is the co-funder of Suzhou Wentai Pharmaceutical
Technology Co., Ltd
. We showed Mr.
Kong
our business plan, which primarily included the results of PESTLE analysis, SWOT
analysis,
and 4P analysis. Following that, we received Mr.
Kong
professional advice on cost planning, product sales, and marketing design, among
other matters.
(Figure 9. Pitch)
Important advice:
(1) At present, there are many products in the
field
of diabetes treatment and all of them are very well developed, how to promote this product through
communication and education is crucial.
(2) The product is still in the animal experiment
stage, and there is still a long way to go from animal
experiments
to human application
s
, so we need to consider that the positioning of
our
product technology should be for drug development manufacturers rather than the clinical
market.
(3) The positioning of the product should be based
on
different designs and target groups, and the limitations of this product and its mechanism of action
should also be taken into account when designing it, which is relatively single for insulin secretion
regulation.
(4) Presenting a good market logic and
demonstrating
advantages over similar products is significant in promoting new products.
(5) Finally, the production and promotion of any
product requires a specific and detailed technology roadmap, which is lacking in this BP, and it is
suggested to add it to the discussion.
5. Conclusion
(1) Despite the high prevalence of diabetes in China and globally, there is a lack of
basic
understanding among people regarding the classification and treatment of diabetes.
(2) The public lacks awareness about different types of diabetes and their treatments.
Therefore, it is essential to conduct well-planned public education activities to promote behaviours
related to public health.
(3) The use of -dependent switch therapy represents a relatively more effective
combined
strategy due to its higher specificity, lower side effects, precision, and the ability for timed and
quantified treatment. As a result, it holds significant importance in the treatment of
diabetes.
(4) Diabetes has different mechanisms of onset among its various types. -dependent
switch
therapy primarily targets the regulation of insulin secretion. Therefore, its effectiveness may need
further evaluation and optimization for patients with insulin resistance and normal insulin
secretion.
(5) Addressing the safety and efficiency of host cells is a key focus of future
research
and an area that needs further consideration in the design.
Our project will provide a more convenient and accurate way of monitoring blood glucose and delivering insulin for the type 2 diabetes patients, which comes with an insulin pump and devices such as bracelets.
The pump can directly detect the health of the body and measure blood sugar levels in real time, enabling patients to better manage their diabetes. The use of this insulin pump greatly simplifies the process of insulin therapy.
To implement our project, we plan to use the power of social media, as well as publish relevant papers on autoritative medical websites and collaborating with pharmaceutical companies.
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