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While insulin pumps may help control glucose levels as well as regular insulin injections among some diabetics, new research suggests that they also appear to carry an increased risk of diabetic ketoacidosis; a condition that causes high blood acid levels, injury and hospitalization.
In a study published in the medical journal The BMJ on March 30, researchers from the United Kingdom compare the effectiveness of insulin pumps to daily injections among type 1 diabetics; which are those born with the disease.
The findings indicate that the pumps can significantly increase the risk of ketoacidosis in comparison.
Researchers evaluated data from clinical trials at eight clinics in England and Scotland, involving 317 patients. About half were implanted with insulin pumps, which monitor glucose levels and automatically inject insulin when needed, and half were given regular insulin injections.
According to the findings, both methods controlled glucose levels about the same, with patients on insulin pumps indicating that they were more satisfied and had better quality of life due to more dietary freedom and no need for the daily hassle of injections. However, the one place where insulin pumps appeared to carry a higher health risk was in the rate of cases of diabetic ketoacidosis, the study indicated.
There were 17 cases of diabetic ketoacidosis among those using the insulin pump, compared to five cases among those receiving regular insulin injections.
“The number or type of serious adverse events did not differ between the groups, witht he exception of diabetic ketoacidosis, which was greater in the pump group compared with multiple daily injections group,” the researchers determined. “Most episodes of ketoacidosis were caused by infections and 18% by set failure in those using pumps.”
The study also warned that those implanted with pumps appeared to be less educated on glycemic control than those who had to self-monitor and take daily injections to regulate their blood glucose levels.
Diabetes Drug Ketoacidosis Risks
The findings come amid increasing concern over the side effects of Invokana and similar diabetes drugs, which have been linked to an increased risk of diabetic ketoacidosis injuries among individuals with type 2 diabetes; which is an acquired disease.
Although ketoacidosis is far more commonly seen in type 1 diabetics, a surprisingly large number of type 2 diabetics taking Invokana have developed the condition since the new-generation drug was introduced in 2013.
Invokana (canagliflozin) was the first member of new class of diabetes treatments, known as sodium glucose cotransporter 2 (SGLT-2) inhibitors. The drug works in a unique way, by altering some normal kidney functions to increase the amount of sugar excreted in the urine.
In December 2015, the FDA required Johnson & Johnson and the makers of other SGLT2 inhibitors, such as Farxiga and Jardiance, to add new diabetic ketoacidosis warnings to their medications. Those Invokana warnings urged users to stop taking the drug and seek immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting.
Less than a year later, in June 2016, the FDA required another warning label update to add information about the link between Invokana and kidney risks, indicating that the medication may increase the risk of acute kidney injury and other severe health problems.
The manufacturers now face a growing number of Invokana lawsuits filed in recent months, each raising similar allegations that the drug makers failed to adequately research the medication before marketing it as a new form of diabetes treatment, and withheld important safety warnings from consumers and the medical community.