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/m2, 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 mixed-effects models. Cluster randomization and repeated measurements were considered as random effects. For the evaluation of HbA1c, fasting blood glucose, and blood pressure in linear mixed-effects models, year of birth, BMI, and differences at baseline were used as covariates. Weight reduction was analyzed in a generalized linear mixed-effects 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).
Baseline characteristics and primary and secondary outcomes of GLICEMIA 2.0
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 = 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 assessment and presented as adjusted effect size, was 0.7 ± 0.2% and statistically significant (P = 0.0001). The weight change in the control and intervention group was −1.1 ± 0.6 kg and −2.7 ± 0.6 kg. For the evaluation of weight as secondary outcome, the number of study subjects who reduced their weight by at least 5% was analyzed; 9.3% (n = 7) of the control group and 26.9% (n = 21) of the intervention group achieved the required weight loss (P = 0.0129). There were not significant differences for fasting blood glucose or blood pressure.
GLICEMIA 2.0 is one of few randomized controlled trials dealing with intensive diabetes care in community pharmacies. The study resulted in a significant reduction of HbA1c within 1 study year in comparison with the control group (0.7%; P = 0.0001). The study has several limitations, such as missing follow-up, high and asymmetric dropout rate, and difference in baseline characteristics between groups, which were taken into account in our statistical analysis. Finally, increased attention during the study procedure might also contribute to the results.
Article Information
Acknowledgments. The authors thank all 26 participating community pharmacies and study subjects for the efforts, the German Diabetes Foundation for counseling, Dr. Anna Laven, Pharmabrain, Berlin, Germany, and Pharmabrain for supporting the education of participating pharmacies prior to the study year, and the Central Laboratory of German Pharmacists for performing interlaboratory surveys.
Funding. GLICEMIA 2.0 was funded by Dr. Anni and Dr. August Lesmüller Stiftung and Förderinitiative Prävention e.V. Abbott Afinion AS 100 Analyzer as well as parts of test cartridges and controls were provided by Abbott Rapid Diagnostics Germany GmbH (the remaining required test cartridges and controls were not free of charge).
Duality of Interest. No potential conflicts of interest relevant to this article were reported.
Author Contributions. K.P. was responsible for the study design and material, monitored study procedure, analyzed and interpreted data, and made a draft of the current manuscript. K.S. developed GLICEMIA, the predecessor and model for GLICEMIA 2.0., and the current study design and study material are based on GLICEMIA. T.H. was responsible for the (generalized) mixed effect models. H.S. and K.F. supervised the development of study design and study material as well as the study monitoring, contributed to the analysis and interpretation of results, and approved the manuscript. K.P. is the guarantor of this work and, as such, had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Prior Presentation. Parts of this study were presented as an abstract, poster, or presentation at the 77th FIP World Congress of Pharmacy and Pharmaceutical Sciences, Seoul, Republic of Korea, 10–14 September 2017; the International Conference on Inter-Professional Education, Makassar, Indonesia, 27–29 September 2017; the 6th Congress for Drug Information, Köln, Germany, 1-2 February 2019; the Annual Meeting of the German Pharmaceutical Society 2019, Heidelberg, Germany, 1–4 September 2019; and the 19th German Congress of Health Services Research, digital, 2020.
- Received September 17, 2020.
- Accepted May 2, 2021.
- © 2021 by the American Diabetes Association