A randomized clinical trial of genetic testing and personalized risk counselling in patients with type 2 diabetes receiving integrated care -The genetic testing and patient empowerment (GEM) trial.

AIMS: We evaluated the effect of personalized risk counseling incorporating clinical and genetic risk factors on patient empowerment and risk factor control in diabetes. METHODS: Patients with type 2 diabetes (T2D) with suboptimal glycaemic control (HbA1c ≥ 7.5%) were randomized to a genetic counselling (GC) or control group. All patients underwent genetic testing for alleles at three loci associated with diabetic complications. The GC group received additional explanation of the joint associations of genetic and modifiable risk factors on risk of complications. All patients were reassessed at 12 months including validated questionnaires for patient reported outcomes. The primary outcome was proportion of patients reaching ≥ 3 of 5 predefined treatment targets (HbA1c < 7%, BP < 130/80 mmHg, LDL-C < 2.6 mmol/L, Triglyceride < 2.0 mmol/L, use of renin-angiotensin system inhibitors). Secondary outcomes included new-onset chronic kidney disease or microalbuminuria and patient reported outcome measures. RESULTS: A total of 435 patients were randomized and 420 patients were included in the modified intention-to-treat analysis. At 12 months, the proportion of patients who attained ≥ 3 targets increased from 41.6% to 52.3% in the GC group (p = 0.007) versus 49.5% to 62.6% in the control group (p = 0.003), without between-group difference. Both groups had similar reduction in HbA1c, LDL-C and increased use of medications. In per protocol analysis, the GC group had higher diabetes empowerment, with reduced diabetes distress. In the GC group, the greatest improvement in positive attitude and self-care activities was observed in the intermediate to high genetic risk score (GRS) groups. CONCLUSIONS: In patients with T2D receiving integrated care, additional counselling on genetic risk of complications did not further improve risk factor control, although the improvement in self-efficacy warrants long-term evaluation.

Association between the 8-item Morisky medication adherence scale (MMAS-8) score and glycaemic control among Chinese diabetes patients.

Adherence with oral hypoglycaemic agent is crucial to achieve optimal glycaemic control. The 8-item Morisky Medication Adherence Scale (MMAS-8) has been frequently used, yet the association between MMAS-8 score and glycaemic control among Chinese diabetes patients is largely unknown. Two general out-patient clinics were randomly selected in a district with socio-demographic characteristics representative of the entire Hong Kong population. A consecutive sample of adult type-2 diabetes patients currently taking oral hypoglycaemic agents was included. The glycaemic control was reflected by the level of hemoglobin A1c (HbA1c) taken within the previous 6 months. Factors associated with poor glycaemic control (HbA1c ≥ 7.0%) were evaluated by linear regression analysis. From 565 eligible Chinese patients with an average age of 63.2 years (SD 9.7) and male proportion of 46.5%, the average HbA1c was 7.1% (SD 1.1%), and 52.0% had poor glycaemic control. The proportion of poor medication adherence (MMAS-8 ≤ 6) was 32.2%. After controlling for socio-demographics, lifestyle, medication use, and health characteristics, the MMAS-8 score was correlated with better glycaemic control (beta -0.095; 95%CI -0.164 to -0.026, P = .007). The MMAS-8 score had a weak and negative correlation with HbA1c level. The instrument should be applied with caution when predicting glycaemic control in clinical practice.