Preventive Care in Type 2 Diabetes: Results of a Randomized, Controlled Trial in Community Pharmacies

Abstract

The number of patients with diabetes is expected to increase by 51% worldwide within the next 25 years, with diabetes complications resulting in high health costs (1). Consequently, comprehensive diabetes care is essential to control disease progression. Pharmacists are able to contribute to diabetes care in different settings (2,3). However, large randomized controlled trials for community pharmacists are rare. Therefore, GLICEMIA 2.0 was developed to examine whether intensive pharmacist-delivered care in community pharmacies can effectively improve glycemic control and reduce risk for complications. GLICEMIA 2.0 was a multicenter, cluster-randomized controlled trial in 26 German pharmacies randomly assigned to the control or intervention group. Pharmacists from each center were trained prior to the start of the trial for 1 day regarding how to conduct the study. Pharmacists of the intervention group received an additional day of training that included medication analysis and counseling of behavioral changes. The Freiburg Ethics Commission International, Freiburg, Germany, approved the trial (016/1826). Eligible participants had type 2 diabetes, BMI of at least 25 kg/m, and HbA1c $7% (53 mmol/mol). Data were collected at baseline and after 6 and 12 months. The assessment included HbA1c (point of care; Abbott Afinion AS 100 Analyzer), fasting blood glucose, weight, and blood pressure. Pharmacists supported the participants of the intervention group for 1 year in a protocol-defined lifestyle change and medication review. Intervention was implemented in three personal counseling sessions, six group meetings, and monthly telephone calls. The control group received written material and usual care. The primary outcome was change in HbA1c within the study year. Secondary outcomes were changes in weight, fasting blood glucose, and blood pressure. The principle of an intention-to-treat analysis was applied, with all available case subjects taken into account. For assessment of efficacy of GLICEMIA 2.0, primary and secondary outcomes were analyzed by (generalized) linear mixedeffects models. Cluster randomization and repeated measurements were considered as random effects. For the evaluation of HbA1c, fasting blood glucose, and blood pressure in linear mixedeffects models, year of birth, BMI, and differences at baseline were used as covariates. Weight reduction was analyzed in a generalized linear mixedeffects model adjusted for sex and year of birth. Twenty-six pharmacies recruited 198 study participants: 94 in the control and 104 in the intervention group. During the study period, 12 in the control and 24 in the intervention group withdrew from GLICEMIA 2.0 (P = 0.060), resulting in a dropout rate of 18.2%. A total of 86 participants of the control group and 96 participants of the intervention group were included in the analysis. Of the complete sample size, 53.3% were female (n = 97), and mean ± SE age of study participants was 65.0 ± 9.5 years. Groups differed at baseline in terms of sex, education level, duration of type 2 diabetes, and attendance in a patient care program (Table 1). During the study period, the control group had reduced HbA1c, mean ± SE 8.1 ± 0.1% (65 mmol) to 7.8 ± 0.1% (62 mmol), and the intervention group achieved a reduction from 8.3 ± 0.1% (67 mmol) to 7.3 ± 0.1% (56 mmol) (Table 1). The results of the linear mixed-effects model showed an adjusted change of 0.2 ± 0.1% in the control group (P 5 0.1454) and 0.9 ± 0.1% in the intervention group (P < 0.0001). The difference between the groups, the effect from first to third