Hypoglycemia and insulin: an innovative solution

Prevention of hypoglycemia in patients with diabetes first and second type implies a strict control of glucose levels in the blood. The patient must constantly monitor their well-being, in time recognizing the first signs of fall of sugar level that can threaten loss of consciousness and even coma!

Hypoglycemia is a pathological reduction of blood sugar levels. Below the threshold of 3.5 mmol/litre. Symptoms of hypoglycemia often develop very slowly and sometimes suddenly. Typically, clinical signs of dehydration are a dehydration, excessive sweating, heart palpitations, muscle tremors, pallor, intense hunger and sometimes fainted.

Because of the rapidly falling blood sugar levels in the bodies of developing functional impairments. Most strongly affected the brain and nervous system. In the adrenal gland sent signals that stimulate them to produce large amounts of adrenaline. The result will involve hepatic glycogen, which is broken down into simple sugars and enters the blood. That is, some time blood sugar rises, but if the person is not going to eat something sweet, then sugar again begins to fall rapidly.

Readers ‘ questions Hello! please help 18 October 2013, 17:25 Hello! please help. tell me. seven years diabetes 1 type. can’t how to cope. he’s not sushitsa me.! I have tried everything. don’t know what I can do.. in the morning sugar high always . talking to dawn. lie with rise 12 15 20 22 vest the day of the fight. a normal evening and morning again the same picture. I’m tired! on the morning of 20 Lantus 4 Novorapid 2 Actrapid. in the afternoon Novorapid 6 2 Actrapid reduction EA dinner 6 8 Novorapid! almost no what not to eat. very little. add Lantus then sindorim Samadi obtained. here was dinner last night went to sleep two hours . rose died 16. then became ill. already 4 hours after poskolky passed. Pomeroy rose to 20. he that does not eat. he wants something and does. signs of Hypo and not Hyper. municipality climi days 11 times a day. all fingers hurt already. there is no place 4000 times a year! working on some stripes.! please advise. for earlier many thanks View answer

What causes hypoglycemia?

As a rule, the condition of hypoglycemia occurs in people with diabetes who use insulin or glucose-lowering drugs. Patients with diabetes should carefully monitor the amount of insulin they inject to the body. It must strictly correspond to the number of pieces of bread eaten. All these rules, teaches a diabetic doctor. Also, the patient must strictly observe all recommendations on nutrition.

If the patient with diabetes widecreen dose of insulin, it will lead to a sharp reduction in blood sugar levels. In large overdose of insulin may develop focal neurologic disorders, seizures, loss of consciousness and the onset of hypoglycemic coma. Very high doses of insulin can cause death of the patient.

Scientists and doctors have learned to produce insulin nearly a century ago, but prices are still quite high in the US, for example, the cost of the drug per month can reach $ 400 and more. According to the statement of the NPR in 2015, in the United States alone, more than 29 million people with diabetes can’t afford the medicine that they face serious complications and even death.

A group of biohackers from San Francisco has created a project called Open Insulin Project, which tries to reduce the cost of insulin, developed a Protocol for its production in the micro-scale. As the name suggests, the platform will be an open resource with the processes and template, available to anyone with the desire and finances to try to manufacture this substance on their own. Thus developers hope to change the way sales and use of insulin. But is it possible? And how is it legally and safely?

The background

To understand how the developers came to this decision, it is important to understand what insulin is, how it’s produced and regulated.

Insulin is a hormone which in healthy people is produced naturally by regulating the level of blood sugar. The body people with diabetes either produce insufficient insulin, or properly respond to insulin levels in the blood. So they need regular injections to stay healthy.

The first wave of insulin for production was taken from pigs and cattle, and then purified. Modern insulin, since the 1970-ies, growing bacteria, genes injected human insulin.

The preparations obtained with the help of living organisms are called biological drugs, production of which is historically more difficult and expensive than drugs obtained by chemical synthesis. Biological products are regulated by the Office of the food and drug administration (FDA) like any other drug, but the U.S. market is represented by only three manufacturers of insulin: Eli Lilly and Company, Sanofi and Novo Nordisk.

Unlike many other medications, a generic version of insulin is only 15 per cent cheaper than its competitors (in other cases, this number reaches 80%). This version also belongs to Eli Lilly and Company. This is partly due to the fact that the introduction of a new drug on the market in compliance with FDA regulations is costly, and few companies are willing to do it for such an old drug like insulin. But what happened to the original insulin?

As a new form of insulin onto the market, older insulin based on animal components simply disappeared, rather than becoming the affordable alternative. The reason, according to experts, lies in the fact that the companies that control these products, do not consider it profitable. From the point of view of net profit it probably makes sense. The unit cost of insulin in the United States increased more than fourfold since the beginning of the century.

To create the drug alone

Because large companies are not going to produce insulin available, people decided to take things into their own hands. According to the principles of software open source Project Open Insulin wants to be the first open Protocol for the production of insulin. That’s what it says on the website:

We hope that our research will be the basis for the generic production of this vital drug.

Anthony Di Franco, co-founder of Open Insulin Project, said the technology of manufacture of biological preparations is not as complex as it seems. Di Franco was diagnosed with type 1 diabetes when he was 20 years old. Opitonui his own to begin a project to always be able to insulin and appropriate assistance in the fight against this disease.

The insulin generated by the project, is an insulin glargine similar to that produced by the Sanofi brand and a little cheaper generic from Eli Lilly. But for the production of insulin by the project will require a much smaller amount.

Is it safe?

The purpose of the project, according to Di Franco, is not to produce insulin for themselves, but rather to create a platform for the production of insulin and other biological drugs at more affordable prices. The result will be a platform for the production of insulin, at a cost not exceeding the price of a small car. The author believes that it’s time to take the reins from the big players and pass anabolism groups, pharmacies, clinics and hospitals.

With regard to security, Di Franco argues that the available insulin can be more secure because of the scale of production. If insulin will be produced in smaller batches, to monitor its quality will be easier.

However, the recent report about the Open Insulin Project in the journal Trends in Biotechnology showed a more skeptical view on the platform. Their review showed that the quality of the drug has more to do with its transportation and storage than the manufacturer himself.

Cold chain management (including transportation and storage) and sampling of biological agents can be more powerful determinants of the quality from the original manufacture.

But the main obstacle, according to the researchers, is normativity.

The only innovative model of insulin which is not subject to regulation, is the production of insulin for personal use. Currently there is no framework for regulatory oversight of non-commercial products.

However, Open Insulin is not alone in his desire to change the situation. At least two other organizations are also working to create small-scale biological drugs. MITs Amino Labs sells a variety of kits for training, including beginners kits manufacturers cost of about $ 2,000, which can be used for the development of bacteria and organisms with a new program DNA. Astudent from the University of Colorado recently conducted a campaign on crowdfunding funding to support students who are trying to develop small-scale production of insulin.