Abstract
Background:
Self-monitoring of blood glucose (SMBG) using the ColourSure™ Technology to visualize target range showed improvement of metabolic control and overall diabetes self-management in insulin-treated patients. This economic analysis aimed to identify cost savings for the German health system resulting from an HbA1c reduction due to the utilization of user-friendly glucose meters.
Methods:
Patient data from a recently published observational study on SMBG were used for risk evaluations using the UKPDS risk engine. These values were integrated in an economic analysis regarding costs of myocardial infarctions (MIs) related to diabetes for the German health system. Based on an earlier assessment these calculations were combined with a 10% reduction of severe hypoglycemic episodes. In the current study, 0% severe hypoglycemic episodes were observed.
Results:
An HbA1c reduction of 0.69% over 6 months was associated with a 3% decreased risk of MI in 10 years. In this model the decrease led to cost savings of €4.90 per patient-year. Considering 2.3 million insulin-treated patients in Germany, this 3% reduction of MI could result in annual savings of €11.27 million. Combining this with a 10% reduction in severe hypoglycemic events, the cost savings would increase to €30.61 per patient-year or €70.4 million for 2.3 million insulin-treated patients in Germany.
Conclusion:
The improvement of metabolic control and diabetes self-management that was achieved with the ColourSure™ Technology has the potential to generate substantial cost savings for the German health system underlining the importance of user-friendly methods for SMBG.
Self-monitoring of blood glucose (SMBG) is a key pillar for successful diabetes management. It enables patients to observe and control glucose levels. A regular measurement of blood glucose levels decreases risks of hypo- and hyperglycemia and might contribute to the decreased risk of follow-up complications such as cardiovascular disease (CVD), retinopathies, and other micro- and macroangiopathies.1-5
A recent study demonstrated that a color-based blood glucose meter can optimize diabetes self-management and glycemic control. Patients’ satisfaction improved significantly while using the ColourSure™ Technology (Johnson & Johnson Diabetes Care Companies, Wayne, PA, USA) resulting in higher SMBG frequency, therapy adaptations, and changes in lifestyle attitudes. Glycemic control, measured by HbA1c and fasting glucose levels, also improved during the 6-month trial. HbA1c levels decreased from 8.68% at baseline to 7.99% after 6 months. 6
Recently, an economic model demonstrated that improvement of HbA1c in insulin-treated patients induced by a SMBG meter translates in substantial annual cost savings for the German health system.7,8
The aim of the current analysis was to introduce the results of the above-mentioned study into an economic model to assess the potential impact of increased self-management of diabetes on expenditures for the German health care system.
Methods
The modeling was based on previous analyses,7,8 combined with data from an observational study published in 2017 6 and modeled for 2.3 million insulin-treated German patients (390 000 type 1 and 1 910 000 type 2 diabetes patients).8,9
To be able to calculate accurate costs for myocardial infarctions (MIs) and severe hypoglycemia in diabetes patients several values were updated. Average annual costs for SMBG were updated. For the SMBG meter with ColourSure™ Technology a price of €12.99 was included. Adding recent prices for test strips and lancets for four measurements per day, average costs for SMBG per year were calculated as follows: 4 × (€0.58 + €0.08) × 365 days + €12.99 = €976.59 (Table 1).
Summary of Parameters Incorporated Into the Analysis.
MI in patients with diabetes was estimated to be 75 600 cases per year, of which approximately 20% were fatal.8,10 The numbers of insulin-treated patients with fatal and nonfatal MI were previously calculated to be 5912 and 23 068, respectively. 8 Hospitalization after MI, as assessed by the German epidemiological CoDiM Study,9,11,12 was calculated to be €9767 per case with additional €4032 for costs related to the first year follow-up after an acute MI (= €13 799; Table 1). 8 Therefore the cost for MI in insulin-treated patients was calculated as follows: 5912 cases × €9767 + 23 068 cases × €13 799 = €57 742 504 + €318 315 332 = €376 057 836. 8
In addition, hospitalization costs after severe hypoglycemic episodes were updated based on current publications: the mean base rate of hospitalization in Germany was €3365.66. 13 Including values from the German Diabetes DRG 2017 K60F (diabetes mellitus age >10 years, 1 day of hospitalization or without very serious complications/comorbidities or without complex diagnosis) 0.707, 14 the updated costs for hospitalization after severe hypoglycemia were €2380 (Table 1).
As in the first modeling publication a frequency of severe hypoglycemia with treatment assistance from outside of 0.64 per patient and year and a frequency of severe hypoglycemia with medical assistance or hospitalization due to impaired consciousness or unconsciousness of 0.19 per patient per year were included.8,15 Of the latter group, 35% required hospitalization whereas 65% could be treated by medical personal. Due to the updated numbers hospitalization costs for severe hypoglycemia were adapted as follows: €520 + €2380 = €2900. As 35% of all cases of severe hypoglycemia are hospitalized and 65% are treated by ambulance only, the average costs for a severe hypoglycemic episode were calculated: (€2900 × 0.35) + (€520 × 0.65) = €1,353 (Table 1).
SMBG with the new blood glucose meter OneTouch® Verio® (Johnson & Johnson Diabetes Care Companies, Wayne, PA, USA) resulted in reduction of HbA1c by 0.69% after 6 months compared to baseline in 172 type 2 and 21 type 1 insulin-treated diabetes patients (Table 2). Systolic blood pressure was unaffected by utilization of OneTouch®Verio®. In contrast, total cholesterol levels were slightly reduced from 198 mg/dl at baseline to 193 mg/dl after 6 months. 6 These values were integrated into the UKPDS risk engine to compare the risk for MI pre- and poststudy. 16 In addition, a poststudy analysis revealed that during the time of the OneTouch®Verio® study 0% of severe hypoglycemic episodes were detected. Instead of integrating this positive result (100% reduction of severe hypoglycemic episodes) into our calculations a 5% and 10% reduction of severe hypoglycemia was included into the model. A 10% reduction of severe hypoglycemia has already been used for previous economic calculations. 8
Patient Data Obtained From Impact on Diabetes Self-Management and Glycemic Control of a New Color-Based SMBG Meter. 6
Results
Applying the UKPDS risk engine for the abovementioned study population enabled the risk estimation of fatal and nonfatal coronary heart disease (CHD - MI) as well as fatal and nonfatal stroke. 17 At baseline the risk for MI in the next 10 years was predicted to be 24.7%. Six months later, the risk decreased to 21.4%. The risk of fatal CHD/MI was reduced from 18.1% to 15.1% (compare Table 3). A reduction of HbA1c by 0.69% resulted in a reduction of MI of approximately 3% (Table 3).
UKPDS Risk Engine Calculations With Patient Data From Table 2.
Including a 3% risk reduction of MI in 2.3 million insulin-treated patients, the annual savings were calculated as follows: total costs for MI €376 057 836 × 3% = €11 281 735 per year or €4.90 per insulin-treated patient and year (Table 4).
Cost Savings per Patient Related to an Improvement in HbA1c of 0.69%.
In addition to a reduction in MI the influence of severe hypoglycemia on costs for the German health system was analyzed.
It has been reported that severe hypoglycemic events occur at a rate of 0.19 times per patient and year. 15 Including a 5% and 10% reduction of severe hypoglycemia, annual savings per patient were calculated as follows:
5% reduction of severe hypoglycemia €1353 × 5% × 0.19 = €12.85
10% reduction of severe hypoglycemia €1353 × 10% × 0.19 = €25.71 (Table 4)
Combining annual savings due to reduced risk of MI (€4.90 per patient and year) and reduced numbers of severe hypoglycemic events (€12.85/€25.71 per patient and year), total savings of €17.75/€30.61 per patient and year were calculated. Considering the number of 2.3 million insulin-treated patients in Germany, this added up to potential annual savings of €40.83 million for a 5% reduction of severe hypoglycemia and €70.40 million for a 10% reduction of severe hypoglycemia (Table 4).
Discussion
The results from a SMBG study using the OneTouch®Verio® glucose meter were integrated into an economic analysis. This enabled the calculation of effective annual cost savings for the German health system for a specific patient population. The SMBG study reported decreasing HbA1c levels from 8.68% to 7.99%. 6 This improvement by 0.69% was associated with a 3% risk reduction of MI in 10 years. This 3% risk reduction of MI alone could save €11.27 million for all insulin-treated patients annually.
Combining the 3% risk reduction of MI with 5% or 10% reduction in severe hypoglycemic episodes annual cost savings increased to €40.83 and €70.4 million for all insulin-treated patients in Germany.
This indicates the high relevance of glycemic control, as hypoglycemia is one of the major cost factors in diabetes management. This is in accordance with other studies, which identify hypoglycemia as a driver of total costs in diabetes. Meng and colleagues found a 59.4% increase in costs for patients with type 2 diabetes with at least one antidiabetic medication claim who were hospitalized after severe hypoglycemic episodes. 18 Another study from Italy concluded that severe hypoglycemia in patients with diabetes is associated with a remarkable economic burden for the national health care systems. 19 Therefore, avoiding severe hypoglycemia with effective SMBG has the potential to influence costs for diabetes patients.6,18
A recent publication analyzed the direct per capita costs, cost ratio of people with and without type 2 diabetes, as well as attributable costs for the years 2009 and 2010 throughout Germany. In Germany €160 billion is expended by statutory health insurances. Of this, 10% (€16.1 billion) is attributable to the medical care of type 2 diabetes patients annually. 20 Earlier studies indicated direct costs for patients with diabetes of €30.6 billion. 9 These differences can be explained by alternative cost calculation strategies. 20 Jacobs and colleagues also showed that the total per capita costs were 1.7-fold higher comparing diabetes patients with nondiabetes people. The biggest difference observed in this publication was in costs for prescribed medication and inpatient treatment of patients with diabetes. 20 Thus potential savings of €40.83 to €70.4 million, as evidenced in the current analysis, could substantially reduce the burden for the German health care system.
Several values were updated compared to the original economic model to include as much up-to-date information as possible. The statistics for hospitalization costs were calculated by trend information and are updated every year. A continuous increase in general hospitalization costs was observed for Germany. Even though study-based data were included into the economic model, this analysis has several limitations. The UKPDS risk engine was designed for type 2 diabetes, but the SMBG trial also included 10% of type 1 diabetes patients. In addition, the values for ethnicity, smoking, and atrial fibrillation could not be provided by the study and were therefore excluded from the risk engine calculations. These factors could have influenced the risk estimation of MI. Nevertheless, the alterations in risk estimation would be minor and could therefore be neglected. Another limitation for the cost calculation was the lack of study-based data for the reduction of severe hypoglycemic events. As the SMBG study focused on the impact of the glucose meter on diabetes self-management and HbA1c as a marker for glycemic control, information concerning severe hypoglycemia was obtained after study termination. Limitations of the economic analysis also include aspects of the observational SMBG study: the number of patients, the relatively short observation time, and the lack of a control group. 6
Conclusion
The incorporation of results of an observational study applying ColourSure™ Technology into an economic model showed annual savings for the German health system of up to €70.4 million. Improvement of diabetes self-management and glycemic control as evidenced in the study could therefore translate into substantial cost savings.
Footnotes
Acknowledgements
We thank investigators and trial-site staff of the OneTouch®Verio® Study and M. Koetzner-Schmidt for poststudy analyses.
Abbreviations
CHD, coronary heart disease; CVD, cardiovascular disease; MI, myocardial infarctions; SMBG, self-monitoring of blood glucose.
Declaration of Conflicting Interests
The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: KF and MH have no conflicts of interest. BG, BC, and KZ are employees of Johnson & Johnson GmbH. OS has acted as member of advisory boards and given lectures for companies that are involved in glucose monitoring and is CEO and founder of Sciarc GmbH.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported by LifeScan, Johnson & Johnson Medical GmbH.