Feasibility Study of a Randomized Controlled Trial Protocol to Examine the Effectiveness of Auriculotherapy (AT) in Improving Sleep Condition and Glycaemic Control in Clients with Type 2 Diabetes

There is increasing evidence to suggest the possibly negative impact of poor sleep condition on glycemic control among patients suffering from type 2 diabetes. As maintaining an optimal glycemic control is the goal of treatment for type 2 patients, such a relationship between sleep and glycemic control suggests the possible beneficial effect of auriculotherapy for promoting sleep on disease management for type 2 diabetes.;The purpose of this study is two-fold. First, it aimed to explore the relationship between quality of sleep and glycemic control among patients with type 2 diabetes. Second, the study examined the feasibility and preliminary effects of sleep-inducing auriculotherapy on sleep quality and glycemic control among patients with type 2 diabetes.;The study was conducted in two phases. Phase 1 was a cross-sectional descriptive study to assess the association of sleep condition and glycemic control among patients with type 2 diabetes. The subjects were recruited from one general hospital and five family medicine clinics in Hong Kong. The sleep quality and glycemic control were measured by the Chinese version of Pittsburgh Sleep Quality Index (CPSQI) and hemoglobin A1c respectively. Data analysis was performed using the Statistical Package for Social Sciences version 18. Multivariable regression was used to assess the association between hemoglobin A1c and CPSQI with adjustment for demographics and medical condition, including age, sex, time since diagnosis of the diabetes and anti-diabetic treatment received.;Phase 2 was a three-arm experimental study comparing the effects of three interventions including: i) sleep-inducing auriculotherapy using magnetic pellets, ii) attention-placebo using semen vaccariae, and iii) no-treatment control on the sleep quality and quantity as well as glycemic control in patients with type 2 diabetes. A total of 60 eligible patients recruited from the hospital were randomly assigned to the three study groups. Same measurement as Phase 1 was used to measure the study outcomes in 4 time-points including baseline, post-treatment, 1 month and 3 months after treatment. Actiwatch was also used to measure the total sleep time and sleep efficiency. Generalized estimating equations (GEE) models were employed to adjust demographic characteristics and other possibly confounding variables for comparing the changes on various outcomes across the time points. The feasibility of auriculotherapy, in terms of acceptability to patients and appropriateness to apply in the clinical setting, was also assessed.;A total of 548 subjects were recruited in Phase 1 with mean age as 63 +/- 10.8 years and 46% were male. The mean diabetes duration was 9 years. Majority of them (77%) were using oral anti-diabetic drugs as the treatment modality. The mean hemoglobin A1c level was 7.3% and mean PSQI at 5.9. After adjusting for the clinical and demographic factors, poor sleep condition was found to be significantly associated with higher A1c level (p<0.05). For Phase 2 study, 60 eligible subjects were recruited. Significant improvement in CPSQI score was detected immediately after completion of auriculotherapy with magnetic pellet and semen vaccariae. The positive effect remained after 3 months of treatment. As for HbA1c, the study only indicated a non-significant trend of reduction after the treatment. Apart from the treatment effect, sleep-inducing auriculotherapy was well received by the subjects and no serious adverse effect and complaint were received. Moreover, auriculotherapy was a simple and not time-consuming procedure.;The study has advanced knowledge on the role of lifestyle factor, particularly sleep quality, on disease control among Chinese patients with type 2 diabetes. Using Traditional Chinese Medicine (TCM) approach, such as the well-known auriculotherapy, is a supplement intervention to improve the sleep condition of diabetic patients. This intervention also has a beneficial effect on their glycemic control. Results of this feasibility study indicated that the auriculotherapy was a safe and appropriate clinical practice for both the patients and the nursing practice environment. The findings also imply the grounds to conduct a more stringent evaluation on the effects of sleep-inducing auriculotherapy on glycemic control in a study with adequate power.