By guest contributors JA Elliott, S Ajmal, and MTU Barone
We applaud the investigators of Besançon et. al 2025 for their randomized control trial of 260 youth living with type 1 diabetes (T1D) in Mali and believe it will prove to be a landmark study in the field of diabetes care in low-income country settings.
The study settles a debate which has gone on for years: in a low-income country settling is long-acting analogue superior to human insulin for T1D management? The results are now in. Long-acting analogues used in a basal bolus regime are clearly superior.
Switching to a basal bolus regime including a long-acting insulin analogue (insulin glargine in this case) led to “a marked improvement” in HbA1c and reduction of diabetic ketoacidosis compared with the control group. The phrase “marked reduction” may even underplay the findings. The mean reduction of HbA1c of 38mmol/mol (3.5%) in the switched group is stark.
These findings also confirm what has been said by people who take insulin for years. In comparison to “human” insulins, insulin analogues usage allows for fewer and less severe hypoglycaemic events, as well as greater flexibility and ease of diabetes management. This in turn improves mean glycaemia, improving peace of mind and better quality of life. Perhaps the most surprising thing about the study is the magnitude of how superior long-acting analogues were relative to human insulin, with a clear potential to delay, reduce or even prevent chronic complications through the well established link with reduced HbA1c.
In addition to this study on long-acting analogues, another publication from Melo et al (2019) has already shown the superiority of short-acting analogues in comparison with regular insulin. In this case, the authors observed reduction in total hypoglycemic episodes, nocturnal hypoglycemia, severe hypoglycemia, in addition to lower postprandial glucose levels. As a result of this systematic review, insulin analogues have been incorporated to the Brazilian public health system, the SUS.
In our view, this evidence must trigger a revaluation among humanitarian organizations and global health leadership. WHO, through its Global Diabetes Compact, has engaged with private sector insulin manufacturers to obtain supply guarantees and technology transfer for human insulin products. Due to questions about the relative superiority and higher prices, WHO has supported human insulin over analogue insulins. While the recent inclusion of long-acting insulins analogues on the WHO Model List of Essential Medicines marked the recognition that analogues convey important clinical benefits to people living with diabetes, critics continue to argue this was a mistake as their advantages did not justify their price tags.
The experiences in Brazil offer another perspective. In Brazil, it was decided that analogues were going to be procured by the Ministry of Health only when they reached the same cost as human insulin. Guess what happened? Due to large volumes and negotiation, the same costs were reached and both short-acting and long-acting insulin analogues are available for free to the ones who need them in Brazil.
In countries like Pakistan where the government has shown some initial responsibility in initiating provision of human insulin, this study provides a fresh perspective on prioritizing analog basal insulin for children and youth with T1D and doing things right from the start. It’s not only about saving lives but also ensuring quality of life which in turn improves the health economy.
As the evidence base in favour of analogue insulins grows and prices fall with market competition, so too do the reasons grow as to why we must no longer accept a double standard of care between high-income and low-income countries. First, there is no evidence that analogue insulins have a markedly higher production cost than human insulin. On the contrary, Barber et al 2024 estimated sustainable cost-based prices for use of insulin in a reusable pen device could be as low as $96 for human insulin vs $111 for insulin analogues per year for a basal-bolus regimen. That is just a $15 per year difference. Second, many humanitarian organizations have internal ethical policies that bar them from knowingly providing and advocating subpar care relative to high income country settings. Third, other disease areas do not employ a similar utilitarian argument of ‘sure it is clearly better but it’s more expensive’. For example, for treatment of multi-drug resistant tuberculosis, modern treatments like bedaquiline are being promoted by global health actors, including by inclusion on the WHO EML and the supply of generic versions through the UN Stop TB Partnership. Cancer care and HIV are similarly chock-full of similar examples of more effective treatments being available to people living with low and middle income countries even where price differentials exist with older less effective molecules. Why should diabetes remain the odd one out?
Our message to global organizations, along with low-income country governments and humanitarian organizations is this: use the tools available to you to improve access to insulin analogue basal-bolus treatment for type 1 diabetes. Larger countries like South Africa can leverage their greater negotiating power to bring down costs; smaller ones can utilize pooled procurement mechanisms as regional blocs. WHO should expand their pre-qualification program to include insulin analogue products. Brand and generic (biosimilar) manufacturers should make use of patent pooling deals and structures that exist to broker them i.e., the Medicines Patent Pool. Advocates and global health actors should apply pressure to the private sector to bring down the prices and encourage tech transfers and domestic production to manufacturers located in low- and middle-income countries. Those with bargaining and convening power should make use of it.
An endocrinologist practicing today in Geneva or London would not start a child living with type 1 diabetes with an insulin like NPH, R or Mix 70/30. But neither should an endocrinologist in Bamako or Johannesburg. The debate is over: insulin analogues are superior. Let’s utilize the studies’ findings and advocate for optimal diabetes care in all settings.
About the authors:
James Elliott is a person living with type 1 diabetes. He has worked with WHO, MSF and other organizations towards better access to medicines, improved care of noncommunicable diseases and inclusive patient advocacy.
Bluesky @jandelliott
LinkedIn https://ca.linkedin.com/in/jamesandelliott
Sana Ajmal has lived with type 1 diabetes for over 27 years. She is the Founder and Executive Director of Meethi Zindagi which is a community led advocacy organization in Pakistan. Sana is deeply invested in community empowerment and advocacy for equitable insulin access.
LinkedIn: linkedin.com/in/sana-ajmal
Facebook: https://www.facebook.com/SanaAjmal84
Mark Barone has lived with type 1 diabetes for 34 years and has dedicated over 25 years to empowerment, advocacy, health education, research, and cross-sector partnerships within noncommunicable conditions.
LinkedIn www.linkedin.com/in/markbarone17/
Disclaimer: Views expressed by contributors are solely those of individual contributors, and not necessarily those of PLOS.