Diabetes developments – by Simon O’Neill
This week Simon updates on technologies, medicines and treatments.
Blood glucose breathalyzer
Researchers at the Western New England University have developed a breathalyzer which they believe will help people with diabetes to monitor their blood glucose levels. The device, which is currently the size of a small book, uses acetone levels in patients’ breath to determine blood glucose levels.
The team tested the breathalyzer device in a small, stage I clinical study of 50 participants – 26 people did not have diabetes, 16 had Type 2 diabetes and 8 had Type 1 diabetes. When patients blow into the device, it immediately takes a reading of the acetone level in their breath which is then correlated to a blood glucose level. The team claim that these early clinical results have shown clear correlations between blood glucose levels and breath acetone.
Although it is known that high blood glucose levels can lead to ketones on the breath, the same is not necessarily true of normal or low levels of blood glucose, so it will be interesting to see if this device is only really able to help when people have high blood glucose levels. This would, of course, make it of limited use to people who take insulin or medications that can cause hypos.
The team are now working to make the device even smaller and believe that it will be on the market by the end of 2017.
Long acting pill
Researchers from MIT in the US have developed a drug capsule that delivers medication for up to two weeks. The device is star-shaped and can be folded inward, on itself, and then encased in a smooth capsule. This then sits in the stomach where acid dissolves the outer layer and the arms of the star stretch out.
The star’s size and design keeps it from being digested further beyond the stomach until the desired time period. The device can then slowly release medication for up to two weeks, though the researchers think this could be increased to a month.
The hope is that this slow release drug delivery system could be particularly helpful in improving compliance with drug taking, especially in people with diseases like Alzheimer’s where memory loss makes compliance with a treatment regimen even harder. Forgetting medicines is very common and it’s known that less than half of people with Type 2 diabetes are still taking their medication exactly as prescribed within two years of starting it.
At present the device has only been tested in pigs but human trials are set to start in 2017, with diabetes being one of the focus areas.
Novo Nordisk have announced that they are shelving their development of an insulin pill, citing the reason for the setback as the potential cost of the drug, which they don’t think payers will cover.
The current version of the pill requires 50 times more insulin inside it than an injection to allow it to be absorbed through the stomach. But as well as the increased cost compared with an insulin injection, the complexity of the development and manufacturing would also have driven up costs to a point where payers would be unwilling to reimburse the pill. The company have been working on the problem for about the last 8 years.
Novo has not totally abandoned the idea of an oral insulin, but will have to go back to basics to solve the dosing problem and to see if there is a better way of getting the insulin to cross from the stomach to the blood stream.
Meanwhile Oramed Pharmaceuticals, a company who had successful Phase 2b research results with its oral insulin drug candidate, ORMD-0801 in Type 2 diabetes, are hoping to meet with the FDA before the end of 2016 to discuss proceeding with a Phase 3 clinical trial in 2017. This will focus on safety and long-term HbA1c lowering efficacy, and will include both active comparator and placebo controlled trials.
It isn’t clear whether these trials will also consider people with Type 1 diabetes but the company are certainly presuming that their technology will be suitable for people with both Type 1 and Type 2 diabetes. In an earlier Phase 2a study, the company demonstrated that ORMD-0801 was safe and well tolerated, and reduced levels of post-meal and daytime glucose in people with Type 1 diabetes.
Interestingly both companies are also working on oral versions of GLP-1 receptor agonists, another hormone which encourages the pancreas to release insulin when blood glucose levels go high. Like insulin, this is also broken down by the digestive system so will need some sort of protection to enable it to be absorbed into the blood stream. Early trials are showing promising results.
Glucose and ketones
A company called Inside Biometrics gained a CE Mark, earlier this year, for their innovative blood glucose meter that simultaneously tests for ketones, using the same sample of blood.
The meter, called Keya, uses a specially designed dual purpose test strip which is able to analyse for both glucose and ketones within 5 seconds on every test. The meter then displays the glucose level and, if ketones are present, alerts the user with a colour coded display – green indicating low levels of ketones, amber for moderate levels and red for high levels. The user can then press an alert button to be shown an accurate reading of the ketone level.
This could prove very useful, especially for younger children or people more prone to episodes of DKA, including those on insulin pumps, as currently, if you get a high blood glucose reading, you need to do a separate urine or blood test to see if ketones are present.
As ketone test strips tend to be used less often, many people find that they have gone out of date by the time they are needed. With this new meter, the ketones are tested automatically, even if blood glucose is in the normal range.
The company are currently working to get the test strips available on prescription.
Next week Simon looks at counterfeit medicines.