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A piggyback approach was used to evaluate the cost-effectiveness of the prevention program delivered at the point of care pharmacy in the GLICEMIA 2.0 study that sought to guide participants in the intervention group to improved glycemic control in type 2 diabetes with sustained incentivization of lifestyle changes, therapeutic compliance, and adherence. The control group received passive medication management and monitoring.Primary endpoint of the GLICEMIA 2.0 study was the stabilization of HbA1c values. For health economic evaluation, incremental differences in output changes were examined, defined as the difference in the distribution of the HbA1c values between both groups over time. Direct program costs and anticipated indirect costs of service utilization were used as cost parameters. A net monetary benefit approach was used to validate cost-effectiveness thresholds via the formation of ICER values.The intervention group had significantly higher reductions in HbAThe GLICEMIA program indicates considerable effectiveness potentials, especially for high-risk patients. The study design seems to have assisted the intervention group's adherence in contrast to the control group. Detailed impacts within the complex intervention could not be validated due to restrictions of the study design as a complex intervention. Overall, statements about effect sustainability and further utilization rates progressions are limited due to a lack of follow-up.Im Rahmen der gesundheitsökonomischen Analyse wurde in einem Piggyback-Ansatz die Kosteneffektivität des am Point of Care Apotheke erbrachten Präventionsprogrammes der GLICEMIA 2.0-Studie evaluiert, das versuchte, die Teilnehmenden in der Interventionsgruppe zu einer verbesserten glykämischen Kontrolle bei Typ-2-Diabetes mit nachhaltiger Incentivierung von gesundheits-bewusstem Verhalten, therapeutischer Compliance und Adhärenz heranzuführen. Die Kontrollgruppe erhielt ein passives Medikationsmanagement und ein Monitoring zum Diabetes-Status.Primärer Endpunkt der GLICEMIA 2.0-Studie war die Stabilisierung des HbADie Interventionsgruppe erreichte signifikant höhere Verbesserungen der HbADas GLICEMIA 2.0-Programm indiziert deutliche Effektivitätspotenziale besonders bei höheren Risikograden. Der Wirkeffekt scheint die Adhärenz der Interventions- im Vergleich zur Kontrollgruppe befördert zu haben. Eine Ermittlung der unmittelbaren Wirkungshebel der Gruppenintervention würde aufgrund des Charakters einer komplexen Intervention einen längeren Zeitraum benötigen. Aufgrund eines fehlenden Follow-up können über längerfristige Effekte nur eingeschränkte Aussagen getroffen werden.

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 …

We aimed to assess the health-related quality of life as well as participant satisfaction during the pharmacy-based diabetes prevention program GLICEMIA.GLICEMIA comprises 3 individual counseling sessions and 5 group-based lectures addressing a lifestyle modification. In a cluster-randomized controlled trial, GLICEMIA was compared with reduced standard information in the control group. After 12 months, the groups were compared regarding the diabetes risk score FINDRISC, health-related quality of life with the 12-item Short Form health survey (SF-12) and participant satisfaction.In total, the data of 1,087 participants were analyzed. During GLICEMIA, 38.9% reduced their FINDRISC whereas 20.9% reached this goal in the control group. Moreover, the physical quality of life improved significantly in the intervention group compared with the control group (adjusted effect size: 2.39 points, 95% CI 1.43-3.34). Participants of GLICEMIA who reduced their diabetes risk had enhanced mental and physical quality of life after one year. This was not observed in the control group. The overall benefit and satisfaction were rated very high in the intervention group.Participation in GLICEMIA results in a significant reduction of the diabetes risk according to the FINDRISC, as well as an improved physical and mental quality of life. The high satisfaction of the participants reflects the overall benefit. Nationwide implementation of the program is recommended.Ziel der Studie war es, die gesundheitsbezogene Lebensqualität sowie die Zufriedenheit während der Teilnahme am einjährigen Diabetes-Präventionsprogramm GLICEMIA zu erheben.GLICEMIA besteht aus drei individuellen Beratungen sowie fünf Gruppenschulungen zur Lebensstiländerung. Im Rahmen einer cluster-randomisierten Studie wurden die Teilnehmer von GLICEMIA mit einer Kontrollgruppe verglichen, welche eine schriftliche Standardinformation erhielt. Nach 12 Monaten wurde die Entwicklung des 10-Jahres-Diabetes-Risikos der Teilnehmer mithilfe des FINDRISK beurteilt. Weiterhin wurde die Veränderung der gesundheitsbezogenen Lebensqualität anhand des Short Form Health Survey SF-12 sowie die Zufriedenheit der beiden Gruppen verglichen.Insgesamt wurden die Daten von 1087 Studienteilnehmern bei der Intention-to-treat-Analyse ausgewertet. Während der Teilnahme an GLICEMIA reduzierten 38,9% ihren FINDRISK, wohingegen dies von 20,9% der Kontrollgruppe erreicht wurde. Hierbei verbesserte sich die körperliche Lebensqualität in der Interventionsgruppe im Vergleich zur Kontrollgruppe signifikant (adjustierte Effektgröße: 2,39 Punkte; 95%-Konfidenzintervall 1,43–3,34). Die Teilnehmer von GLICEMIA, welche ihr Diabetes-Risiko reduzierten, hatten nach einem Jahr eine verbesserte psychische und körperliche Lebensqualität. Dies konnte in der Kontrollgruppe nicht beobachtet werden. Gesamtnutzen und Zufriedenheit mit dem Programm wurden in der Interventionsgruppe als sehr hoch eingestuft.Die Teilnehmer von GLICEMIA hatten mit einem signifikant niedrigeren 10-Jahres-Diabetes-Risiko sowie einer verbesserten körperlichen und psychischen Lebensqualität einen hohen Nutzen vom Programm. Dieser hohe Gesamtnutzen spiegelt sich auch in der Zufriedenheit der Teilnehmer wider. Ein flächendeckendes Angebot des Programms sollte angestrebt werden.

OBJECTIVE The aim of this study was to assess the efficacy of a 12-month prevention program conducted in 42 community pharmacies in reducing the risk for diabetes. RESEARCH DESIGN AND METHODS In a cluster-randomized controlled trial in 1,092 participants, mean change in the risk for diabetes (indicated by the Finnish Diabetes Risk Score [FINDRISC]) between intervention and control groups was calculated. In the intervention program GLICEMIA, three appointments with individual counseling and five educational group sessions were combined, whereas in the control group, only information about the participants’ health was obtained in three assessments. RESULTS After adjusting for cluster structure and differences in baseline characteristics, improvement in FINDRISC in the intervention group was 0.74 points (95% CI 0.42–1.04) above the control group. CONCLUSIONS The GLICEMIA program shows the feasibility of a pharmacy-based intervention and leads to a significant modest reduction in diabetes risk score but does not reduce the rate of diabetes progression over 1 year.