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▎Insulin edited by WuXi AppTec's content team is an important treatment method for many diabetic patients.
For these patients, the daily preservation of insulin also needs to be taken care of.
It is generally believed that insulin is neither resistant to high temperature nor low temperature.
Unopened insulin needs to be stored in the refrigerator at 2°C ~ 8°C.
Insulin that has been opened and in use can be stored at room temperature (about 25°C) and protected from light.
More than 4 weeks; also need to avoid repeated shocks in different temperature environments.
In reality, it is difficult for many patients to preserve insulin completely and correctly.
A survey involving nearly 4,000 Chinese patients showed that 23% of the patients did not store their insulin in the refrigerator before turning on the insulin; nearly half of the patients still stored their insulin in the refrigerator after turning on the insulin.
A recent study has brought an uncommon sense of good news to the challenge of insulin preservation.
This study shows that a variety of insulins can be stored for 4 weeks in the oscillating temperature range of 25°C-37°C without deterioration of effect.
This is much looser than the conventionally recommended storage conditions.
This research has also received special attention in the latest issue of "The Lancet-Diabetes and Endocrinology", and related reports and articles commented, "This can make it easier for diabetic patients to adhere to effective treatment.
"
Screenshot source: The Lancet Diabetes & Endocrinology This research comes from a collaborative team of the international medical humanitarian organization Doctors Without Borders (MSF) and the University of Geneva, and was recently published in the academic journal PLoS One.
The original intention of the study was that the researchers noticed that in many resource-poor environments around the world, the ambient temperature is often difficult to meet the preservation requirements of insulin.
This research was carried out in a laboratory and simulated the temperature fluctuation environment of a refugee camp in northern Kenya: a typical situation is from 25°C at night to 37°C during the day.
Compared with insulin stored at 2°C ~ 8°C according to the standard, exposed to this experimental fluctuating temperature for 28 days or even as long as 12 weeks, the physical structure (measured by liquid chromatography) and biological activity of the existing commercially available insulin There is no difference in appearance (by liver cell detection) or insulin.
This is true whether it is human insulin or insulin analogues.
The study was published in PLoS ONE, the author of the study, Dr.
Leonardo Scapozza, professor of pharmaceutical biochemistry at the University of Geneva, explained, “As heat increases, insulin will gradually precipitate, but there will be a'reversal point'.
Usually, if you cool down again, insulin can still be reversed to normal.
Conformation.
In such a temperature oscillating environment, insulin (the structure and activity) will not be irreversible.
” Another study author, Dr.
Philippa Boulle, head of the non-communicable diseases group of MSF, added, “Cooling at night The denaturation of insulin protein can be avoided, even if the temperature is only reduced to 25 degrees-this is the maximum storage temperature recommended by most insulin instructions.
"Image source: 123RF For diabetic patients in resource-poor areas and humanitarian crisis environments, this means High temperature and lack of refrigeration are no longer obstacles to insulin therapy.
They can complete insulin injections at home without frequent daily visits to medical and health institutions.
According to statistics from the World Health Organization, approximately 422 million people worldwide suffer from diabetes, most of whom live in low- and middle-income countries.
Dr.
Philippa Boulle said, "Currently, only 50% of patients who need insulin therapy actually receive the treatment.
This study brings us one step closer to the goal of '100% of patients in need receive insulin therapy'.
" According to the research team, in the real environment simulated by the experiment, thanks to the patients being able to inject insulin at home, the number of emergency hospitalizations there has been drastically reduced.
For developed regions, the results of this study are also very important.
For example, the need to travel with insulin and it is inconvenient to refrigerate, or accidentally leave the insulin in the car for several hours, or encounter extreme weather, which can alleviate the problem of insulin preservation.
Image source: Other findings of the 123RF research are consistent with existing knowledge.
Studies have found that if they are continuously exposed to an ambient temperature of 31°C, all insulin preparations begin to degrade after 4 weeks, and their biological activity is also reduced.
After continuous exposure to an ambient temperature of 37°C for 1 week, two of the insulins began to degrade.
An important message is that when insulin does degrade, particles will appear in the vial.
"Insulin should not be used at this time.
" Professor Scapozza reminded, "but if it does not look abnormal, it can still be used within 28 days.
" In addition, it is still recommended to store insulin at about 4°C before opening and using it.
"This is a landmark study, and we need more such studies to understand whether longer storage time is feasible.
" said Dr.
Silver Bahendeka, chairman of the East African Diabetes Research Group (EADSG).
In addition, the research team also pointed out that there are still some key questions that need to be answered before updating this finding to the insulin instructions.
For example, will other temperature changes have an impact? Does this conclusion also apply to the 23℃ ~ 40℃ situation? Does the length of time of different temperatures have an effect, such as 25 ℃ ~ 27 ℃, but the daytime with higher temperature is as long as 18 hours.
At present, the research team has carried out further research, the evaluation temperature range is larger, the average temperature is higher, in order to better understand whether the current research results are universal.
I hope that these findings will enable more diabetics to receive more convenient treatment! Related reading Let diabetics say goodbye to daily injections! Once a week, the new long-acting insulin welcomes important progress, and publishes two results in the "Lancet" sub-journal: rewriting the textbook! Clinical trials have proved for the first time that oral insulin and injections have comparable efficacy.
Reference materials[1] Kaufmann B, et al.
, (2021).
Heat-stability study of various insulin types in tropical temperature conditions: New insights towards improving diabetes care.
PLoS ONE, DOI: https://doi.
org/10.
1371/journal.
pone.
0245372[2] Munyaradzi Makoni.
(2021).
Insulin storage without refrigeration.
The Lancet Diabetes & Endocrinology, DOI: https://doi.
org/10.
1016/ S2213-8587(21)00057-7[3] Contrary to Popular Belief, Insulin Can Be Stored Outside Fridge.
Retrieved March 29, 2021, from Open Insulin Can Actually Be Stored at Warm Temperatures For Weeks, Scientists Find.
Retrieved March 29, 2021, from you need guidance on treatment plans, please go to a regular hospital for treatment.
For these patients, the daily preservation of insulin also needs to be taken care of.
It is generally believed that insulin is neither resistant to high temperature nor low temperature.
Unopened insulin needs to be stored in the refrigerator at 2°C ~ 8°C.
Insulin that has been opened and in use can be stored at room temperature (about 25°C) and protected from light.
More than 4 weeks; also need to avoid repeated shocks in different temperature environments.
In reality, it is difficult for many patients to preserve insulin completely and correctly.
A survey involving nearly 4,000 Chinese patients showed that 23% of the patients did not store their insulin in the refrigerator before turning on the insulin; nearly half of the patients still stored their insulin in the refrigerator after turning on the insulin.
A recent study has brought an uncommon sense of good news to the challenge of insulin preservation.
This study shows that a variety of insulins can be stored for 4 weeks in the oscillating temperature range of 25°C-37°C without deterioration of effect.
This is much looser than the conventionally recommended storage conditions.
This research has also received special attention in the latest issue of "The Lancet-Diabetes and Endocrinology", and related reports and articles commented, "This can make it easier for diabetic patients to adhere to effective treatment.
"
Screenshot source: The Lancet Diabetes & Endocrinology This research comes from a collaborative team of the international medical humanitarian organization Doctors Without Borders (MSF) and the University of Geneva, and was recently published in the academic journal PLoS One.
The original intention of the study was that the researchers noticed that in many resource-poor environments around the world, the ambient temperature is often difficult to meet the preservation requirements of insulin.
This research was carried out in a laboratory and simulated the temperature fluctuation environment of a refugee camp in northern Kenya: a typical situation is from 25°C at night to 37°C during the day.
Compared with insulin stored at 2°C ~ 8°C according to the standard, exposed to this experimental fluctuating temperature for 28 days or even as long as 12 weeks, the physical structure (measured by liquid chromatography) and biological activity of the existing commercially available insulin There is no difference in appearance (by liver cell detection) or insulin.
This is true whether it is human insulin or insulin analogues.
The study was published in PLoS ONE, the author of the study, Dr.
Leonardo Scapozza, professor of pharmaceutical biochemistry at the University of Geneva, explained, “As heat increases, insulin will gradually precipitate, but there will be a'reversal point'.
Usually, if you cool down again, insulin can still be reversed to normal.
Conformation.
In such a temperature oscillating environment, insulin (the structure and activity) will not be irreversible.
” Another study author, Dr.
Philippa Boulle, head of the non-communicable diseases group of MSF, added, “Cooling at night The denaturation of insulin protein can be avoided, even if the temperature is only reduced to 25 degrees-this is the maximum storage temperature recommended by most insulin instructions.
"Image source: 123RF For diabetic patients in resource-poor areas and humanitarian crisis environments, this means High temperature and lack of refrigeration are no longer obstacles to insulin therapy.
They can complete insulin injections at home without frequent daily visits to medical and health institutions.
According to statistics from the World Health Organization, approximately 422 million people worldwide suffer from diabetes, most of whom live in low- and middle-income countries.
Dr.
Philippa Boulle said, "Currently, only 50% of patients who need insulin therapy actually receive the treatment.
This study brings us one step closer to the goal of '100% of patients in need receive insulin therapy'.
" According to the research team, in the real environment simulated by the experiment, thanks to the patients being able to inject insulin at home, the number of emergency hospitalizations there has been drastically reduced.
For developed regions, the results of this study are also very important.
For example, the need to travel with insulin and it is inconvenient to refrigerate, or accidentally leave the insulin in the car for several hours, or encounter extreme weather, which can alleviate the problem of insulin preservation.
Image source: Other findings of the 123RF research are consistent with existing knowledge.
Studies have found that if they are continuously exposed to an ambient temperature of 31°C, all insulin preparations begin to degrade after 4 weeks, and their biological activity is also reduced.
After continuous exposure to an ambient temperature of 37°C for 1 week, two of the insulins began to degrade.
An important message is that when insulin does degrade, particles will appear in the vial.
"Insulin should not be used at this time.
" Professor Scapozza reminded, "but if it does not look abnormal, it can still be used within 28 days.
" In addition, it is still recommended to store insulin at about 4°C before opening and using it.
"This is a landmark study, and we need more such studies to understand whether longer storage time is feasible.
" said Dr.
Silver Bahendeka, chairman of the East African Diabetes Research Group (EADSG).
In addition, the research team also pointed out that there are still some key questions that need to be answered before updating this finding to the insulin instructions.
For example, will other temperature changes have an impact? Does this conclusion also apply to the 23℃ ~ 40℃ situation? Does the length of time of different temperatures have an effect, such as 25 ℃ ~ 27 ℃, but the daytime with higher temperature is as long as 18 hours.
At present, the research team has carried out further research, the evaluation temperature range is larger, the average temperature is higher, in order to better understand whether the current research results are universal.
I hope that these findings will enable more diabetics to receive more convenient treatment! Related reading Let diabetics say goodbye to daily injections! Once a week, the new long-acting insulin welcomes important progress, and publishes two results in the "Lancet" sub-journal: rewriting the textbook! Clinical trials have proved for the first time that oral insulin and injections have comparable efficacy.
Reference materials[1] Kaufmann B, et al.
, (2021).
Heat-stability study of various insulin types in tropical temperature conditions: New insights towards improving diabetes care.
PLoS ONE, DOI: https://doi.
org/10.
1371/journal.
pone.
0245372[2] Munyaradzi Makoni.
(2021).
Insulin storage without refrigeration.
The Lancet Diabetes & Endocrinology, DOI: https://doi.
org/10.
1016/ S2213-8587(21)00057-7[3] Contrary to Popular Belief, Insulin Can Be Stored Outside Fridge.
Retrieved March 29, 2021, from Open Insulin Can Actually Be Stored at Warm Temperatures For Weeks, Scientists Find.
Retrieved March 29, 2021, from you need guidance on treatment plans, please go to a regular hospital for treatment.
