Keywords: Participatory medicine, diabetes, blood glucose.
Citation: Frost JH. Innovations in participatory medicine: the advent of do-it-yourself blood glucose monitoring. J Participat Med. 2010 Sep 14; 2:e7.
Published: September 14, 2010.
Competing Interests: The author has declared that no competing interests exist.
The American Diabetes Association (ADA) currently recommends that people injecting insulin for diabetes test their blood sugar three or more times a day. The notion that self-monitoring is instrumental in controlling blood glucose is now well understood. But this was not always the case. Prior to widespread use of insulin from the 1930s, people with type 1 diabetes were treated with a regimen of semi-starvation. Even when insulin injections became a widespread treatment, people did not know their actual blood glucose levels, making injections more dangerous and the incidence of hypo- and hyperglycemic episodes common.
The advent of blood glucose self-monitoring is a representative case study in participatory medicine. It illustrates how technological developments and patient advocacy combined to produce a treatment breakthrough that represented a major improvement in the life expectancy and quality of life for the millions of people living with insulin-dependent diabetes. It is a story of innovations in monitoring technology and the efforts of one particularly determined patient to gain access to this technology and realize its potential, going on to advocate for widespread access to it for patients.
Prior to the invention of the blood glucose monitor, it was impossible to measure anything less than very high blood sugars. In ancient China, diabetes was recognized after people observed that ants would gather around the urine of those affected because it was sweet. In 1776, the sweetness was definitely identified as sugar. Although Frederick Banting and Charles Best discovered insulin in 1935, and patients were able to inject insulin to lower their blood sugars with some success afterwards, measuring the effect of insulin injections on reducing blood sugar remained illusive. Up through the 1960s and 1970s the only way to infer blood glucose levels was by testing urine. But the problem is that once sugar levels have reached the renal threshold, blood levels are quite high. Because of the crudeness of the measure, it was mainly used to screen for diabetes rather than control glucose levels. There were some efforts to monitor blood glucose over time by looking at urine samples. Unfortunately, urine glucose monitoring did not appear to improve self-management in intervention studies. Direct measurement of blood glucose — an integral part of current diabetes self-management — and its adoption by large numbers of Americans only happened in the early 1980s.
To understand this revolution in diabetes treatment requires going back to the 1960s. During that time, Ames Pharmaceuticals developed strips that could measure how much sugar was in the blood, which it marketed under the name Dextrostix. To use a strip, the patient or provider placed a drop of blood on the strip, waited for about a minute and then wiped off the excess. The strip turned a different color of blue depending on the glucose level. The user had to visually inspect the strip to interpret the color and gauge the corresponding reading. As a result, although these strips are crucial to measuring blood glucose, interpretation of the results was often inaccurate. These strips became more useful after Tom Clemens, an engineer at Ames Pharmaceuticals, developed an optical reader to analyze the color of the strip and translate it into a numeric reading. His research resulted in the ARM (Ames Reflectance Meter). A similar Japanese technology, the Eyetone, was also marketed by Ames.
The engineers at Ames intended for these meters to be used by patients themselves. Perhaps as engineers, they had some insight that patients may be able to use these devices for their own purposes. Unfortunately, the legal department at Ames was not as forward thinking. They had concerns about the liability associated with home use by nonprofessionals. So despite having been developed for self-monitoring, the meters were instead distributed to health care providers. The technology remained under the control of clinicians, who used them mainly to screen patients for diabetes. Patients regularly injecting insulin continued to do so without knowing their blood sugar levels. Thus despite the advent of a monitoring technology capable of allowing patients to control glucose levels with a higher degree of success, it remained out of reach to ordinary patients. Physicians told patients that control over glucose levels was not feasible.
The innovation in blood glucose monitoring technology was certainly a necessary step for developing self-monitoring as a treatment, but it was not sufficient. The transformation in diabetes treatment came not from the technology itself, but from how one patient, Dick Bernstein and his supporters, fought for the ownership of the technology, chose to use it, and then advocated for its widespread distribution.
In 1942, as a 12-year-old, Bernstein developed type 1 diabetes. He was treated with insulin injections, administered, of course, without knowing his precise glucose levels. He later became an engineer and was able to more or less manage his diabetes. The problem was that like many diabetics, even when he followed the low-fat diet doctors prescribed, he continued to suffer frequent hypoglycemic episodes that frightened his family and damaged his health and began to experience complications of the disease. Seeing a reflective monitor, he wanted to experiment with one himself. Confronted with the restriction that monitors were to be used and prescribed only by physicians, Bernstein asked his wife, a psychiatrist, to get him one. Dick Bernstein thus became the first patient to own and use a blood glucose meter by circumventing existing efforts to keep the technology in the hands of health care providers. He began to measure his glucose levels regularly and noted fluctuations throughout the day. With frequent monitoring, using his reading to adjust his insulin dosages, he realized he could regulate his blood levels and decrease the incidence of hypoglycemic episodes.
Having experienced this personal health transformation, Dick Bernstein became a champion for patient-monitoring and good self-management. He established close relationships with inventors in the industry and helped companies organize and fund innovations in designs. He presented at professional meetings and asked manufacturers to present their monitors to patients at conferences. Internationally, manufacturers and providers were more open to Dick Bernstein’s ideas. Ames received private funding to develop a portable monitor for patients that was then distributed throughout Europe and the Middle East in the late 1970s.
Bernstein found, however, that on his own even as an engineer, a diabetic, and a precursor to the current “Quantified Self” movement, in the US he was unable to be a strong advocate for patient monitoring. Journals refused to publish his studies. He elicited the help of the marketing department at Ames, a man named Charles Suther, and through him, of medical editors. But even with this help Bernstein was unable to get his writings published in the US. The American Diabetes Association (ADA) was skeptical of Bernstein’s ideas and renegade attitude towards medical practice. As a 43-year-old, highly focused on his own health and determined to share his insights, Bernstein therefore decided to become a doctor. He attended Albert Einstein Medical School and became an endocrinologist. After graduation, he formed a practice treating other people with diabetes.
Although Dick Bernstein did not invent glucose monitors, he transformed how the technology was used and who used it. As a patient-participant in his own care, he had a personal insight about his own practice and became a crucial force that resulted in a fundamental shift towards participatory medicine in diabetes care. He was not the first patient to monitor blood sugars. But he was the first patient to have a blood glucose monitor and insights about the value of regularly self-monitoring glucose levels.
It was only during this period, in the early 1980s, that the ADA changed its position and began to officially recommend that patients monitor their own blood sugars. There are now about a dozen types of monitors on the market. Glucose meters still operate using the same basic technology of calibrating glucose levels using strips, which are translated into a reading by a monitor. Although still prone to small errors based on temperature, altitude, and other environmental factors, monitors are now small, inexpensive, and widely available. In 2006, sales of glucose monitors and insulin pumps reached $9 billion in the United States. While technologies might have been the precursor to this example of participatory medicine, it was a patient who forced a change in the use of these technologies and, simply, who could use the device.
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Copyright: © 2010 Jeana H. Frost. Published here under license by The Journal of Participatory Medicine. Copyright for this article is retained by the author(s), with first publication rights granted to the Journal of Participatory Medicine. All journal content, except where otherwise noted, is licensed under a Creative Commons Attribution 3.0 License. By virtue of their appearance in this open-access journal, articles are free to use, with proper attribution, in educational and other non-commercial settings.