Extrait

Background and study aims In routine clinical practice, the most accurate way to diagnose diabetes is by conducting an Oral Glucose Tolerance Test (OGTT). An OGTT is conducted in a clinical setting (hospital or GP surgery) and involves taking blood from a vein before and after consumption of a standard sugary drink. The blood samples are sent to a laboratory for measurement of the levels of sugar (glucose) in the blood. This test can also detect changes in blood sugar levels before diabetes develops (pre-diabetes). This study evaluated a new electronic OGTT kit that measured the level of sugar in fingerprick blood samples and was designed to be used by untrained individuals in their home. The study investigated whether the kit produced accurate and repeatable blood sugar measurements, whether participants were able to use the kit unaided, and what their feelings were about performing the test themselves. Who can participate? The study involved 30 participants, of whom 12 had previously diagnosed type 2 diabetes (stable for the last 3 months using diet or metformin only), 18 did not have known diabetes. The participants could have been male or female and were aged 18 or over. What does the study involve? Participants were asked to use the electronic OGTT kit on six occasions. The kit used fingerprick blood samples and did not require any laboratory involvement or trained personnel. The electronic OGTT kit was assessed in 3 different settings: 1. Two home-based (and unobserved) tests 2. Two clinic-based and observed tests (preferably without any nurse intervention) 3. Two clinic-based and nurse-led tests During the two nurse-led visits, venous blood samples for laboratory measurement of sugar were taken in tandem with the fingerprick blood samples. No drugs (oral, topical or injected) were being tested in this study. What are the possible benefits and risks of participating? There was no direct benefit to the participant from this study. The results of this study may provide valuable information about the future use of the electronic OGTT kit by the general public. This knowledge may be used to help others by enabling widespread screening of individuals in regions with limited access to clinical staff and laboratory resources. In the unlikely event that participants had previously unrecognized impaired glucose tolerance or diabetes this would have been detected so that treatment could be commenced at an earlier stage to give greater benefits. Some people may have felt nausea if they consumed the glucose drink too quickly. Some people may have experienced sore fingers after the finger pricks. Occasionally there may have been local bruising as a result of blood drawn from the vein. Where is the study run from? Clinical Research Unit at the Oxford Centre for Diabetes (Oxford, UK). When is the study starting and how long is it expected to run for? The first participant was recruited in April 2011 and the last visit took place in July 2011. Who is funding the study? Novartis Pharma AG (Basel, Switzerland). Who is the main contact? Prof M. Angelyn Bethel [email protected]

Critère d'inclusion

• Diabetes type 2

Liens

• isrctn
• ictrp