N of 1 trials in diabetes: making individual therapeutic decisions

Abstract

N of 1 trials are single-subject, randomised, crossover studies, in which the patient serves as their own control to compare the efficacy of a treatment. They offer an alternative to large, randomised clinical trials, which have limited applicability, and empirical testing, which is arbitrary in nature. N of 1 trials are regarded as providing the highest strength of evidence for individual subject decisions. They rely upon the patient expressing preferences and making shared decisions for determining the future therapy, and may therefore lead to the successful implementation of lifestyle interventions. N of 1 trials are an optimal approach for making therapeutic decisions in chronic diseases like diabetes mellitus, where decision-making is often reliant upon arbitrary criteria and clinical judgement.

Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach: Position Statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

“…26 During the clinical encounter, the patient's preferred level of involvement should be gauged and therapeutic choices explored, potentially with the utilization of decision aids. 21 In a shared decision-making approach, clinician and patient act as partners,mutually exchanging information and deliberating on options, in order to reach a 27 There is good evidence supporting the effectiveness of this approach. 28 Importantly, engaging patients in health care decisionsmay enhance adherence to therapy.…”

Exploring the Economic Implications of a Group-Based Lifestyle Intervention for Middle-Aged Adults with Chronic Schizophrenia and Co-Morbid Type 2 Diabetes

“…There are arguments for adopting patient-tailored rather than guidance-led treatment strategies [29]. Reflecting service users' choices by taking into account their personal circumstances and preferences in the future programmes may lead to more feasible and persistent behavioural changes.…”

Stochastic Resonance Effects on Apnea, Bradycardia, and Oxygenation: A Randomized Controlled Trial

“…The use of each infant as his or her own control provides the highest strength of evidence for individual infants by removing the interpatient variability from the comparison between the intervention periods, and provides unbiased estimates for the differences associated with SR stimulation. 11 Because we did not otherwise alter the clinical care of the infants in the NICU, the effects of the SR stimulation were in addition to those of supplemental oxygen and caffeine, because several infants were already receiving these treatment modalities. Infants who were clinically receiving supplemental oxygen and/or caffeine received an additional benefit from the SR stimulation, which was similar in magnitude of improvement in the number, duration, and intensity of oxygen desaturation events and intensity of bradycardia events.…”