A New Day in Monitoring is Dawning
Some of you may remember diabetes in the days before we had today's home blood glucose testing devices. Back then, patients relied on urine tests to gauge their blood glucose levels – a method that lacked precision, only revealed what the blood glucose level had been several hours prior, and didn't identify hypoglycemia, only hyperglycemia. Today's home blood glucose monitors are smaller, quicker, and more accurate, and the transition to these was a huge step forward in patients' quality of life and glycemic control.
While urine testing was once considered a great breakthrough, we now consider it primitive. The question we've now got, having just returned from the European Association for the Study of Diabetes in Athens, Greece – the major annual European diabetes meeting – is whether blood glucose monitoring is once again poised to take a huge step forward, as the advent of real-time continuous monitoring comes upon us.
Several companies are working to develop continuous sensors that will give frequent (every few minutes) readings of blood glucose. Most of these systems include two parts: a sensor self-inserted beneath the skin and a separate device that receives beamed information from the sensor and displays the glucose reading. Alarms can be set to warn the wearer of hypoglycemia and hyperglycemia. More importantly, some systems feature trend arrows that report whether the blood glucose is increasing or decreasing, and at what rate, based on a series of readings; all information that will give tremendous power to patients.
The new technology is thought to have benefits for both short-term and long-term glycemic control. In the short term, the trend arrows and frequent readings should allow patients to prevent hypoglycemia and hyperglycemia. A patient who sees that his glucose is dropping rapidly at 80 mg/dL (4.44 mmol/l), for example, might be able to treat it before the onset of hypoglycemic symptoms. Likewise, the trend information may allow patients to make better decisions: someone with a blood glucose reading of 70 mg/dL (3.89 mmol/l) with rapidly rising glucose would act differently than someone else with the same glucose reading but rapidly dropping glucose. With today's home monitoring systems, this finer distinction cannot be made.
The information may also help patients and doctors adjust insulin or oral medication in the longer term. Dr. David Klonoff of Mills Peninsula Hospital, an expert on the subject, compares continuous monitoring to a video recording and today's episodic monitoring to a snapshot. Right now, we can gauge overall glycemic control only by the "snapshots," having little idea what kind of excursions, or peaks and valleys, might occur in between those. Continuous monitoring will fill in these gaps.
The latest buzz around continuous monitoring was the presentation of the GuardControl trial results at EASD. GuardControl was a three-month study designed to see what effects continuous, real-time data might have on glycemic control in patients. Of the 162 patients included in the study, one-third wore a continuous sensor for the full length of the study, one-third wore it only intermittently, and one-third did not have access to real-time data. The results of the study showed that the new technology helped patients manage their diabetes. The group with the continuous, real-time data saw a reduction in their HbA1c of 1.1%, from a baseline of 9.6%.
"The results of our study clearly show that continuous glucose monitoring with real time glucose readings is a powerful tool to improve glucose control in type 1 diabetes patients (both adults and children) with inadequate metabolic control," said Dr. Jan Bolinder, the presenter of the GuardControl study at EASD and one of the principal investigators of the study.
In addition to a drop in HbA1c scores, the group with the continuous monitors also saw less frequent and less severe hypoglycemia. They did not have a reduction in the number of hyperglycemic events, but the length of these events was reduced. This study is one of the first of its kind. It quantified the therapeutic value of continuous monitoring and showed that it may be precisely the tool patients need to achieve the glycemic targets set out by the ADA.
The GuardControl trial used Medtronic's Guardian device, which was approved by the FDA in July and in Europe earlier this year. A limited launch in a small number of U.S. cities this fall is planned for the device, which is indicated for use in patients with type 1 and type 2 diabetes who are 18 and older and who are looking for improved glucose control.
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NOTE: The information is not intended to be a replacement or substitute for consultation with a qualified medical professional or for professional medical advice related to diabetes or another medical condition. Please contact your physician or medical professional with any questions and concerns about your medical condition.
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