Has Dr. Denise Faustman Found a Cure for Type 1 Diabetes?

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A new study from the Faustman Lab at Massachusetts General Hospital suggests that a nearly 100 year old tuberculosis vaccine called BCG may hold cure-like promise  for people  with Type 1 diabetes. The bacillus Calmette-Guérin (BCG) vaccine, one of the oldest vaccines in the world, was developed for tuberculosis protection and for early stage bladder cancer therapy. 

In Dr. Faustman’s small, ongoing trial, patients lowered their blood sugar levels to near normal, and blood sugar levels in the patients have remained near normal for five to eight years. (See StatNews for more.)

The press release states:

“Three years after receiving two administrations of the bacillus Calmette-Guérin (BCG) vaccine four weeks apart, all members of a group of adults with longstanding type 1 diabetes showed an improvement in HbA1c to near normal levels – improvement that persisted for the following five years. The study from a Massachusetts General Hospital (MGH) research team – published in npj Vaccines – also reports that the effects of BCG vaccine on blood sugar control appear to depend on a totally novel metabolic mechanism that increases cellular consumption of glucose.

“BCG has been known for more than 30 years to boost production of a cytokine called tumor necrosis factor (TNF), which may be beneficial in autoimmune diseases both by eliminating the autoreactive T cells that attack an individual’s tissues – in the case of type 1 diabetes, pancreatic islets – and by inducing production of regulatory T cells (Tregs) that could prevent an autoimmune reaction. Faustman’s team first reported in 2001 that inducing TNF production could cure type 1 diabetes in mice, but since TNF dosing is toxic in humans, clinical trials have utilized BCG for its ability to elevate TNF levels safely.

Initial clinical trial results, published in a 2012 PLOS One paper, reported that two doses of BCG spaced four weeks apart led to reductions in autoreactive T cells, an increase in Tregs and what turned out to be a transient increase in insulin production. But by the end of that short, 20-week trial, there was no reduction in HbA1c, the established measure of blood sugar levels over time. An extension and expansion of that trial with long term follow-up, the current results are based on data from 282 human study participants – 52 with type 1 diabetes who participated in the BCG clinical trials and 230 who contributed blood samples for mechanistic studies.

Regular monitoring of clinical trial participants found that HbA1c levels of those receiving BCG had dropped by more than 10 percent at three years after treatment and by more than 18 percent at four years. That reduction was maintained over the next four years, with treated participants having an average HbA1c of 6.65, close to the 6.5 considered the threshold for diabetes diagnosis, and with no reports of severe hypoglycemia. Participants in the placebo group and in a comparison group of patients receiving no treatment experienced consistent HbA1c elevations over the same eight-year time period.

In investigating how BCG administration produces its beneficial effects, the research team identified a mechanism never previously seen in humans in response to treatment with any drug – a shifting of the process of glucose metabolism from oxidative phosphorylation, the most common pathway by which cells convert glucose into energy, to aerobic glycolysis, a process that involves significantly greater glucose consumption by cells. The researchers also found that BCG could reduce blood sugar elevations in mice that were caused by means other than autoimmune attack, raising the possibility that BCG vaccines could also be beneficial against type 2 diabetes.”

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Sarah
Sarah

We have to be careful here. I live with type one, and study type one everyday. The sample size in the 5-year follow-up was 9 people, and in the eight year follow-up was 3 people. This information is revealed by Dr. Faustman in the online supplementary material of the published manuscript. It is deceiving to say there were 282 study participants for the follow-up portions of the trial that are currently being widely publicized. Check it out here: https://static-content.springer.com/esm/art%3A10.1038%2Fs41541-018-0062-8/MediaObjects/41541_2018_62_MOESM1_ESM.pdf That said, this work is interesting, and exciting, but we cannot stop looking for ways to help the daily lives of… Read more »

Errin
Errin

I would forever be grateful for a cure. I wouldn’t know how to react without a pump or cgm, needles, pump supplies, and the gazillion medications I am forced to take to lessen my complications. How it would be to live a life of freedom. I pray this day comes soon for all of us suffering this horrible disease we didn’t deserve.

Cary
Cary

Good research and fascinating, but so far does not look to be a “cure”. It may prevent the development of type 1 diabetes and other autoimmune diseases but an A1C of 6.5 is not a cure. It would interesting to see how much insulin each group is using and by what means. Making diabetes easier to manage is certainly a noble goal as well. If someone can keep an A1C of 6.5 without much effort, that is great progress. But with the new 670g and other “bionic pancreas” projects, people may have an easy time keeping A1C in the 6-7… Read more »

neil
neil

Without knowing the standard deviation, range or compliance at 80-130, or how much insulin dependence has been liberated, especially during the first 3 years, an A1C of 6.5 is just a number. My son oscillates between an omni pod and injections. His A1C over the past five years has ranged between 6.1 and 6.6. Well managed, but hardly cured.

Randy
Randy

If this means I can get an A1c of 6.5 without any insulin then that would be great in my case. I’m type 1 diabetic that has to exercise after my meals to get my blood sugar levels down. Having a low due to insulin causes severe problems due to chronic sinus infections that won’t go away due to diabetes. I bike 31 miles after my 1st meal and walk 5 mile after my next meal which allows me to keep my insulin usage very low for a type 1. It would be a big help in my case even… Read more »

Cary
Cary

The question is did this reduce their insulin need? That is not addressed in the study. And it also says “no severe lows”.. which probably means no lows requiring assistance.

I completely agree that having a “cure” that reduces he need for insulin at all and gives you an a1c if 6.5 is amazing… but I don’t think that is the case or the paper would have reported it that way.

I have hope for great things in the next 10 years, but think it will more be on improvements in closed loop systems and possibly new insulin delivery modes.

Theresa
Theresa

Patients remained on insulin; it is addressed in the original article.

Theresa
Theresa

Patients were still using insulin, just less of it. It isn’t mentioned in this article, but the PLoS links to another article. I wish the original article was accessible.

Ivan
Ivan

Is this experimental treatment covered by my health insurance? Or maybe this is a never ending experiment that insurance will never cover.

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