Q&A with Dr Jim Faed - QUESTION SIX What is the likely criteria for a T1 being part of the trial? As a general statement, we plan to include the following in the requirements – 1. Absence of other major organ disease /health problems that could affect the patient’s ability to take part in the trial. 2. Age - probably 18-50 years, but still subject to further discussion as some age-related changes may produce technical problems. 3. Demonstrated ability to manage T1D well and not encounter a lot of hypoglycaemic episodes or high HbA1c values (levels are yet to be defined). a. Access to HbA1c data from the past 2 years to permit medical review of the level of diabetic control achieved. 4. Must be able to come the clinic for regular monitoring tests. We will aim to try to build in flexibility around working hours for those in paid employment. As the clinical trial will be carried out in Dunedin it will effectively be limited to people living in the locality. The final details on acceptance criteria will always be subject to discussion by the research group at the time the protocol is finalised and subsequent approval by the Health and Disability Ethics Committee.
Posted on: Mon, 12 Aug 2013 06:29:15 +0000
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