However, randomization and blinding are not always possible. To successfully engage patients, priority should be given to health care professionals being engaged, operational support in technical issues being available, and adherence being assessed in detail.Īnother difficulty is to avoid contamination of the control group with the intervention therefore, strict allocation concealment should be maintained. Lessons from the STeP and ProValue studies demonstrated the difficulty in medical device studies that rely on behavioral changes in intervention group patients. This article aims to provide challenges in interpreting diabetes management intervention studies and suggests approaches for optimizing study implementation and for avoiding pitfalls based on current experiences. ![]() Such studies thus have to be well designed in order to allocate all observed effects to the defined intervention and to exclude effects of other confounders as well as possible. However, chronic disease management is intricate with complex multifactorial behavior patterns. Several clinical studies investigated improvements of patient outcomes due to diabetes management interventions.
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