Glucose meter

A blood glucose meter is an electronic device for the determination of glucose content of the blood ( blood sugar). For this purpose, a blood sample is venous, arterial or capillary blood taken and applied to a test strip, and then examined with the aid of the measuring device. In the commercial there is a variety of devices with different features.

• 4.1 Quality criteria in Germany
• 4.2 Quality of blood glucose monitoring

• 5.1 Cost control of the statutory health insurance in Germany

Legal classification

Germany

Blood glucose monitors are medical devices according to § 3 No. 4 Medical Devices Act ( MPG). They provide aid is in accordance with § 33 SGB V and are in the resource directory of the statutory health insurance under the product group 21 ( 2.7 meters for body states / functions ) listed.

Entitlement to blood glucose test strips as provided by statutory health insurance is p 1 SGB V regulated separately in § 31 paragraph 1, they shall, therefore, no legal aid represents the test strips are basically in accordance with § 31, paragraph 3, sentence 2 SGB V without additional payments. Regardless of the legal classification of blood glucose test strips are treated organizationally similar medicines by health insurance for simplicity, but do not count to medicines in the legal sense, but stay medical devices and aids accessories according to § 3 No. 9 MPG. However, the selling price incl VAT flows in the output volume of the doctor.

Technology

The first devices for home use certain sugar content photometrically. For this purpose, a drop of blood on a test strip into a beam path inside the device was placed. The sugar content was then determined from the characteristic light absorption of the reacting with the glucose test strip chemistry. This light absorption is dependent on the glucose concentration.

In amperometric measurement commonly used today, the blood is applied to a small test strip and the test strip is drawn through a capillary to a non- visible from the outside the test field. Here, the glucose reacts with an enzyme, e.g. Glucose oxidase and closes the contact between different electrodes. The blood glucose meter creates these contacts a defined voltage and measures over time, the current that is passed through the blood. From the current course of the unit then determines the blood sugar levels.

There are devices that are based on a photometric measurement even today. In this case, a dye is created or modified by the enzymatic conversion of glucose. The color change can be converted into blood glucose value.

In Germany, the blood glucose both from capillary whole blood as well as from kapillärem plasma is currently possible. Depending on the manufacturer, the calibration is performed either at the device level or on the test strip. In both cases, the blood from the finger pad ( fingertip ) is obtained for this purpose. The values ​​determined from kapillärem plasma are approximately 11-15 % higher. To avoid confusion or a likelihood of the measured values ​​and corresponding medication errors, a uniform transition to plasma calibration is recommended.

In the laboratory, the blood sugar from venous plasma is determined. For diagnosis of diabetes mellitus only in the laboratory by wet chemical determined value is permitted, as this is more accurate.

Functions

Like all devices of electronics are constantly being developed and BZ- measuring devices: The devices are smaller, cheaper, faster ( measuring duration of recent devices 3-5 sec ) and become more powerful, the drop of blood needs a volume of about 0.4 microliters. Apart from the actual blood sugar determination have modern instruments over a number of special features designed to facilitate the handling of the patient. This includes, for example, an illumination of the insertion opening for blood glucose test strips or the display so that the measurement can be carried out even in poor lighting conditions. Especially for visually impaired diabetics, there are also devices with a short-term extra-large display of values ​​or devices with the presentation in warning colors at elevated or low blood sugar as well as devices with voice function that announce the measured values ​​in addition to displaying on the display, either in German or Turkish.

Many devices also feature individually adjustable memory function, indicating a pending measurement by a beep. Individual devices also possess a device that allows you to insert more test strips in the network, that for several consecutive measurements (eg traveling) no strip change is required. Today is a coding of newly fractured test strip packs with most devices no longer necessary.

But above all newer devices offer several options for logging, processing and association of the measured blood glucose levels, for example, information on the medication as well as with personal diet and exercise data, which decrease the handwritten performing a diabetes diary to the patient and allow him greater mobility and flexibility. It can store hundreds of individual blood glucose values ​​are stored, calculated averages over several weeks and maximum and minimum values ​​are reported. In addition, numerous instruments offer patients the opportunity, under certain preferences information on meals, exercise or information about the subjective being ( " feel uncomfortable ", " stress" ) to enter.

A wide array of devices can now transfer this data by means of special medical software via a USB or infrared interface to a computer; the logged values ​​can be read out for example in diabetes care practice or to your home PC or transferred to an Internet portal in a preloaded patient record that can see also the treating physician. In addition to this direct transmission, in which the blood glucose meter is connected directly to a computer, there is also the possibility to transmit the corresponding values ​​through an intermediary transmitting device from the meter to an online portal; since a few years this is also possible by mobile phone: originally in a 3-component communication from the meter via Bluetooth to a mobile phone equipped with special software and from there to an online diabetes journal. This allows a direct communication between patient and doctor and eg an automatic alarm message to the medical staff at impending metabolic disorders. Recently, allows an extra little device type that was designed specifically to attach to an iPhone, using a special app each immediate online processing of the measured values ​​, and sending it by e -mail.

Safety and reliability of the equipment is largely ensured in patients everyday, although " the quality of the measurement quality devices from different manufacturers ... a considerable bandwidth" having.

Accuracy

Erroneous readings often result from mishandling, be it that the hands were not washed thoroughly before measurement and eg at the blood collection site still adhered sugar residues, the fingertip too much " milked " and was more or less tissue fluid ( lymph) is added or the test strips were not properly sealed and stored.

Quality criteria in Germany

The acceptable accuracy of blood glucose meters is regulated in Germany by DIN EN ISO 15197. Put simply must at 95 % of the glucose readings, the deviation from the reference measurement value 15 mg / dl does not exceed (0.83 mmol / l) and 20% respectively. The 15 mg / dl (0.83 mmol / l) are doing for glucose values ​​<75 mg / dl (< 4.2 mmol / l), for measured values ​​≥ 75 mg / dl ( ≥ 4.2 mmol / l) are the 20%. If a blood glucose meter obtain a CE marking, the evidence must be provided that this requirement is complied with.

According to the guidelines of the German Medical Association for quality assurance laboratory medical examinations ( RiLiBÄK ) is the " allowable relative deviation of the individual value " at 11 %, the " permissible relative deviation of the ring test " at 15 %. Treatment of diabetes mellitus type 1, the insulin- treated type 2 diabetic patients and in the treatment of gestational diabetes blood glucose self-monitoring have become indispensable.

Quality of blood glucose meters

In a test that has been published in July 2012 by the Stiftung Warentest, were 12 of 16 blood glucose meters that are available in Germany, " good" of the note, three were "satisfactory" and a "poor". The accuracy of measurement was one of the final grade in the test with 60 percent. She was with the established measuring instruments always "good", two were so far "very good". Even among the so-called " B units " whose blood glucose test strips are sold cheaper, there were devices with " good " accuracy. For this issue of the A and B units, the working group has submitted diabetologic Technology ( AGDT ) of the German Diabetes Association an opinion ..

Costs and importance of blood glucose self-monitoring

The self-testing is recommended for both insulin-dependent and non -insulin -dependent diabetics as an "important element of diabetes therapy" in all approved training programs. In a statement, the German Diabetes Association and other associations is emphasized that the blood glucose self-monitoring even in non insulin-dependent type 2 diabetes is a " crucial for the motivation, training and treatment of patients."

Cost control of the statutory health insurance in Germany

The cost of blood glucose self-monitoring by the patient will be reimbursed in insulin-dependent diabetics by statutory health insurance in Germany. The prescribing practices differ depending on the province. In diabetic patients with intensive insulin therapy and a requirement of 5 measurements per day, ie 150 test strips per month, costs the equivalent of about 75 euros.

To reduce costs, the association of spare cash has contracted with the German Pharmacists Association October 1, 2010, that the pharmacies in the future to convert 10 % of prescriptions of blood glucose test strips for private plans insured on products of better value for the cash price group (B).

In non-insulin -dependent patients with diabetes mellitus type 2, the costs are by decision of the G -BA in March 2011 be accepted only in exceptional cases and only limited: according to maximum only in unstable metabolic condition at initial or at change of treatment with a high risk of hypoglycaemia per treatment situation 50 test strips per quarter remain on prescription. This decision was approved on 23 May 2011 pursuant to § 94 SGB V by the Federal Ministry of Health, not objected to, announced on June 16, 2011 in the Federal Gazette and entered into force on 1 October 2011.

The evaluation by IQWiG in 2009, relied on by the Federal Joint Committee, "returned neither for blood glucose self-monitoring nor for urine glucose self-monitoring a proof of benefit in patients with type 2 diabetes who are not treated with insulin. (... ) from the epidemiological studies on the subject, no evidence of association of blood glucose self-monitoring with morbidity and mortality resulted. " The German Diabetes Associations diabetesDE, DDG, VDBD, BVND and DDS criticize this review and call for maintaining the regulation ability of blood glucose test strips.

The increasing cost pressure had led to the end of 2012, that the established manufacturers to übergegingen to lower the price of some test strips. In November 2012 took place at the private plans a nationwide grouping these test strips in the lower price group (B). For the primary cash compensation prices are regional, that is, on the particular state based negotiation. The negotiations take place between the primary funds and the country's pharmacy association ( LAV ). Depending on the state of the processing performed by the manufacturer Roche price reduction also causes a reduction in the tax rates. For example, the selling price in Hesse is calculated as follows: pharmacy purchase price (AEP ) 5 % VAT. This gross amount flows into the output volume of the doctor.