Note to our followers: Our nearly 13-year run of daily publication of new content on HealthNewsReview.org came to a close at the end of 2018. Publisher Gary Schwitzer and other contributors may post new articles periodically. But all of the 6,000+ articles we have published contain lessons to help you improve your critical thinking about health care interventions. And those will be still be alive on the site for a couple of years.
Read Original Release

Device for type 2 diabetes: Release prematurely touts benefits from 60-person study

Development of a wearable medical device for type 2 diabetes

Our Review Summary

DiabetesThis release describes research published in Nature Scientific Reports involving mild electric stimulation (MES) and heat shock via a belt-type medical device to promote visceral fat loss and improve blood glucose in patients with obesity and Type 2 diabetes. The research highlighted is the next chapter in what has been a multi-year effort on the part of the investigators to develop a new approach to the treatment of Type 2 diabetes. The researchers’ previous work in animals and now in a small cohort of people with Type 2 diabetes is not well represented in the release. There’s no clear discussion of how the device works.

[Editor’s note: This review was revised to reflect that a funding source was included, but in an easily overlooked sidebar on its EurekAlert! entry. We encourage news release authors to include funders in the text of the release as well so that when the release is picked up and republished, the funding information is included.]

 

Why This Matters

Type 2 diabetes has reached epidemic proportions in the United States and in the developed world. Present treatments include lifestyle changes, drugs and for those with morbid obesity, surgery. A new approach to its treatment focusing on heat shock proteins has been in the making for a number of years. The development of a low impact and wearable device that could reduce blood sugar levels and prevent the consequences of long term Type 2 diabetes would be a welcome step forward. Only additional research, however, will demonstrate whether the device described in this release will live up to the expectations of the investigators.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

The news release makes no mention of the potential cost of the device. A potential source of comparison is Ab toner and waist trimmer electronic belts of various brands sold at Walmart. They vary from the $21.25 Healthmate Forever AB Muscle Stimulation Multi Belt, to the $149 Ab Transform Pro Abdominal, Arm and Leg Training System.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Satisfactory

The release provides quantification of the benefits of the device but would have been a lot stronger with a better description of what some of the numbers mean. It states:

“The reduction in the visceral fat area was 5.37 sq. cm in the 2 treatment per week group, 14.24 sq. cm in the 4 per week group and 16.45 sq. cm in the 7 per week group. Declines in HbA1c were 0.10%, 0.36%, and 0.65% in the 2, 4, and 7 treatment-per-week groups respectively.”

It also stated, “About half of all subjects (52.5%) achieved less than 7.0% HbA1c, which is a treatment goal for diabetes” in reference to the first study. (HbA1c refers to glycated haemoglobin (A1c), which identifies average plasma glucose concentration.) But the release doesn’t explain the relationship between lowering of HbA1c and improvements in heat shock protein, an important underpinning of the research. The information detailed in the graphic, while related to the basic research, is confusing since it relates to the animal and not the human research described in the release.

A statement from the lead investigator appears premature. Dr. Kondo commented: “Even in patients who have difficulty exercising, such as those who are overweight, elderly, or have some form of disability, this device can be expected to provide acceptable treatment in addition to conventional diabetic medical care.”

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

The belt device is claimed to be well tolerated, but no details on potential harms are given. The release notes: “The team found that a suitable combination of mild electrical stimulation (MES) with heat shock (HS) activated HSP72 more efficiently.” What is the electrical stimulus and how uncomfortable is it?  Exactly what is a delivery of heat shock? What temperature is used? And finally is the device battery operated or is it a plug in?  All of these unanswered questions seem relevant to understanding the device.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

The release describes the study methods — the number of participants, the length of treatment, and the results. But the release would have been stronger with a discussion of the study limitations. According to the published study, limitations included its “relatively small sample size and no setting of appropriate placebo control because this apparatus simultaneously delivers heat and mild electric stimulation, both of which are easily recognized by subjects.”

Does the news release commit disease-mongering?

Satisfactory

No disease mongering here. The release provides a good description of the mechanics of Type 2 diabetes. The release might have been improved with a brief discussion of the prevalence of the disease.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

The news release notes that the study was funded by the Japan Agency for Medical Research and Development, Grants-in-Aid for Scientific Research. The journal article in Scientific Reports also acknowledges the belt device was provided by the Tsuchiya Rubber Co., Ltd. (Kumamoto, Japan).

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

The release mentions exercise and a drug commonly prescribed in Japan to treat Type 2 diabetes, and notes that using the device “One can expect the effects to be similar to exercise therapy.” It also quotes a researcher who suggests the belt could be an add-on to conventional diabetic medical care. But the release provides no indication of how the device actually compares with these existing treatments in terms of outcomes.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

Even though the researchers advanced from theoretical thinking to animal and human trials there is no discussion of when the device might become available to patients.

Does the news release establish the true novelty of the approach?

Satisfactory

Heat shock protein has been explored as an important factor in Type 2 diabetes by other researchers. The researchers have taken the basic research and moved it one step closer to patients.

Total Score: 5 of 10 Satisfactory

Comments (3)

Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.

Kurt Tripp

November 25, 2016 at 9:14 am

I have been following Dr. Jason Fung from Toronto Canada, and his amazing work on Diabetes and weight loss with intermittent Fasting. We need more doctors looking at causes of these diseases and finding real solutions and less snake oil dealers trying to make a quick buck by masking the symptoms.

Reply

Jason Sanderson

November 29, 2016 at 11:39 pm

I edited this release and agree with most of your critique. We will endeavor to be better. However, I do feel the need to point out that the funding source is clearly displayed on the right side of the EurekAlert webpage which is why it isn’t mentioned in the release.

Reply

    Kathlyn Stone

    November 30, 2016 at 12:01 pm

    Thanks, Jason, for pointing out the location of the funder information. I’ve revised the review to reflect that it was included in the sidebar. We encourage news release authors to include funders in the text of the release as well so that when the release is picked up and republished, the funding information is included. I’m glad you found the review helpful.
    Kathlyn Stone, Associate Editor

    Reply