Pan-European Economic Analysis to Identify Cost Savings for the Health Care Systems as a Result of Integrating Glucose Monitoring Based Telemedical Approaches Into Diabetes Management

Abstract

Background:

Self-monitoring of blood glucose supported by the diabetes-app OneTouch Reveal® has demonstrated to improve HbA1c. We aimed at analyzing costs savings related the integration of telemedical features into diabetes management.

Methods:

Data from a randomized controlled trial were used to assess the 10-year risk of patients for fatal myocardial infarction (MI). On the basis of this risk assessments—also related to a 5% or 10% reduction of hypoglycemic episodes—cost savings for the health care systems of five European countries—France, Germany, Italy, Spain, and the United Kingdom—were modeled.

Results:

HbA1c reduction of 0.92% in insulin-treated type 2 diabetes patients (T2DM) was associated with a 2.3% decreased 10-year risk for fatal MI. In combination with a 10% reduction of hypoglycemic events this risk reduction led to cost savings of €16.1 million (France), €57.8 million (Germany), €30.9 million (Italy), €23.8 million (Spain), and €5.8 million (UK), considering all insulin-treated T2DM patients in the respective countries.

Conclusion:

Improving metabolic control and thus risk for comorbidities like MI by combining the glucose meter with CRI with telemedical features has the potential to reduce costs for European health care systems.

Diabetes mellitus is a chronic condition affecting about 8.8% of the population worldwide, imposing huge economic burden on health care systems. In 2017 health care expenditures due to diabetes in Europe were $166 billion—growing constantly—attributed mostly to diabetes-related complications.¹ Through regular and efficient self-monitoring of blood glucose (SMBG) glycemic control can be optimized,¹ the acute and long-term complications reduced and in turn the health care expenditures scaled down.^2,3 Also SMBG enables to better detect hypoglycemia events.^4,5

Utilization of telemedicine, a combination of telecommunication and medical devices,⁶ together with usual care has been suggested to support patients and health care providers (HCPs) in diabetes management. It can facilitate the timely management of diabetes trough sharing real life data, leading to an improvement in SMBG and optimization of HbA1c.^7,8 Furthermore, patients more regularly and more frequent control their blood glucose and medical errors are minimized.⁹

To support patients in the interpretation of results and optimize their diabetes management, utilization of new technology such as a glucose meter with color range indicator (CRI) may be beneficial.^10-13 In addition, a mobile application (app) can be provided, which can automatically transmit data to a “cloud” where they can be analyzed, stored, and transmitted back to the app and a web-based application, thus enabling HCPs access to the measured data (Figure 1). The analyzed data give suggestions for diet or physical activity and, most importantly, enable the patients and the HCPs to drive informed decision on diabetes management, giving the possibility for communication with the patients via text messaging (SMS) or remote consultations to facilitate SMBG.¹⁰

Figure 1.

Data from the glucose meter are sent to the cloud-based web application. Data on the cloud are analyzed, stored, and transmitted back to patient’s smartphone application and/or computer as well as to a health care professional. Health care professionals reviewed the 14-day app report for each participant to assist in formulating diabetes-related text messages sent to the participant’s smartphone. Source: The Omni Group, Omni Graffle [Version 7.7.1] [Seattle, WA; 2018]).

A recent randomized control trial (RCT) tested telemedicine intervention. Grady et al¹⁰ studied how utilization of a glucose meter with CRI (OneTouch Verio Flex®, LifeScan, Wayne, PA, USA) alone or combined with the app (OneTouch Reveal®, LifeScan) influences HbA1c. The study showed significant improvement in glycemic control in patient with both type 1 and type 2 diabetes (T1DM and T2DM). Moreover, patients reported a reduced time in hypo- and hyperglycemia.¹¹ HbA1c in the overall study population decreased by 0.66% in patients of the intervention group (meter + app). In T2DM patients the reduction was greater 0.92% when using the meter and the mobile app.¹¹ Consequently, it confirms that the use of telemedicine may improve treatment and management of diabetes in T1DM as well as T2DM.

Recent economic analyses from Germany showed that optimization of HbA1c in diabetes patients through glucose meter with CRI may reduce health care expenditures.^14,15 Cost-effectiveness evaluations of rapidly emerging telemedicine interventions in diabetes based on RCTs are rather well established in the United States, yet it is still very much in its infancy in Europe.¹⁶ Lack of economic evaluations of such interventions may be the main obstacle to further develop and implement such interventions in the routine clinical practice.

Therefore, we compared the costs savings modeled for the two interventions studied in the abovementioned RCT: (1) use of glucose meter with CRI and (2) use of glucose meter with CRI in combination with a mobile app.¹⁰ Cost-effectiveness estimations were developed for five European countries: France, Germany, Italy, Spain, and the United Kingdom.

Methods

The cost-effectiveness analysis was based on a previously published economic model^14,15,17 and adapted as follows:

First, to estimate current costs, parameters from France, Germany, Italy, Spain, and the United Kingdom were extracted from databases, registries, and cost-estimate publications (summarized in Table 1).^18-52 Average annual costs were modeled for each country for all insulin-treated diabetes patients (including patients with T1DM and T2DM) with regard to fatal and nonfatal myocardial infract (MI) and severe hypoglycemic events (based on costs for ambulance and hospitalization).

Table 1.

Summary of Parameters Incorporated Into the Analysis.

Country	France	Germany	Italy	Spain	UK
Insulin-treated patients	677 17018	2.3 million19	864 00020	1 154 97021	767 41822
Type 1 diabetes	185 00018	390 00023	190 000	272 95621	368 95122
Type 2 diabetes	492 170	1.91 million	674 000	882 014	398 467
Percentage of severe hypoglycemia (patient/year)
Hospitalization	35%24	35%24	33%25	35%24	35%24
Emergency treatment/ambulance	65%24	65%24	67%25	65%24	65%24
Number of very severe hypoglycemia	0.1626	0.1927	0.1927	0.1927	0.1927
Number of myocardial infarction/year in insulin-treated patients with diabetes	258728,29	28 98030	17 96931	173232	260333
Fatal	25929	591230	209131	30834	85935
Nonfatal	2328	23 06830	15 878	1424	1744
Hypothetical reduction in severe hypoglycemic events	5% / 10%	5% / 10%	5% / 10%	5% / 10%	5% / 10%
Annual costs for SMBG	€721.89	€976.59	€365	€156	€477
Glucose meter	€64.89	€12.99	€0a	€0a	€0
Test strip	€0.38	€0.5830	€0.40	€0.2836	€0.2937
Lancet	€0.07	€0.0830	€0.10	€0.15	€0.0337
Average costs for hypoglycemic episodes/patient/year
Ambulance	€69338	€52039	€20540	€49641	€30042,43
Hospitalization	€436044	€238039	€531740	€249441,45,46	€116542,43
Average cost	€1976	€1353	€960	€1369	€708
Costs for myocardial infarctions/year
Acute	€587047	€976719	€11 75748	€713049,50	€255451
Follow-up (first year)	€327647	€403219	€258948	€15 95552	€619342,43
Successfully treated MI	€9146	€13 799	€14 346	€23 085	€8748

Currency exchange rate £1 = €1.1271 (October 2018).

^aFree of charge.

Second, 24-week outcome data from the study by Grady et al¹¹ were applied to the UKPDS risk engine⁵³ to estimate changes in clinical outcomes (fatal and nonfatal MI and stroke) in the next 10 years. Additional values for blood pressure and lipids were taken from a previously published observational study on SMBG with CRI technology.¹⁷

Third, the estimated risk reduction of MI in the next 10 years from the UKPDS risk engine and a hypothetical reduction of 5% and 10% of severe hypoglycemic episodes^15,30 was translated to the population of all insulin-treated patients to calculate annual monetary savings per patient per year and then extended to annual savings for the health care systems of five European countries: France, Germany, Italy, Spain, and the United Kingdom.

All costs were calculated in the European Union currency euro for both meter only and meter + app group of the study.¹⁰ National currency of the United Kingdom was converted into euros using nominal exchange rates from the HM Revenue & Customs department of the UK government from October 2018 (£1 = €1.1271).

Cost Estimates (Table 1)

Self-Monitoring of Blood Glucose (SMBG)

Average annual cost of SMBG were calculated based on recent prices for test strips and lancets multiplied by average measurements per day (France, Germany, the United Kingdom 4 measurements per day,³⁰ Italy 2 measurements per day,⁵⁴ Spain 1 measurement per day³⁶), multiplied by 365 days and added to the price for a glucose meter (GM). Financing scheme of the GM vary between countries.

$$\begin{array}{l}Notests/day\times \left(\overline{x}priceofstrip+\overline{x}priceoflancet\right)\\ \times 365days+priceGM=\mathrm{SMBG}\overline{x}\mathrm{cost}/year\end{array}$$

Myocardial Infraction (MI)

Expenditures were estimated for both fatal and nonfatal MI events based on current numbers from various national and international publications.^28-35 Percentage of fatal events were extracted from overall MI events in the diabetes population. Nonfatal MI events were calculated for acute and nonacute MI events for successfully treated patients within one year. Successful treatment was calculated based on the acute treatment cost summed with first year follow-up cost. For both fatal and nonfatal MI the average costs were calculated as the number of cases per year multiply by average costs for specific treatment.

$$\begin{array}{l}\left(fatalMIcases\times \overline{x}acutetreatmentcost\right)+\\ (non-fatalMIcases\times \overline{x}\left(acute+1styearfollow-upcosts\right)\\ =MI\overline{x}cost/year\end{array}$$

Severe Hypoglycemia (SHE)

First, the number of SHE events was derived from two publications.^26,27 Average cost for hypoglycemia included costs for hospitalized and ambulant treated patients.^38-46 The percentage of hospitalized patients were multiplied by the average costs of hospitalization and summed with percentage of ambulance-treated patients multiplied by average ambulance costs.

$$\begin{array}{l}\left(\%ofhospitalisedpatients\times \overline{x}costofhospitalisation\right)+\\ \left(\%ofambulantpatients\times \overline{x}costofambulanttreatment\right)\\ =SHE\overline{x}cost/year\end{array}$$

UKPDS Risk Engine (55)

Reduction of HbA1c after 24 weeks in overall population (0.56% meter only, 0.66% meter + app) and T2DM population (0.63% meter only, 0.92% meter + app) compared to baseline¹¹ and the data of Schnell et al¹⁷ (systolic blood pressure, total cholesterol, HDL cholesterol) (Table 2) were applied to UKPDS risk engine to predict 10-year risk reduction for fatal and nonfatal MI and stroke.

Table 2.

Patient Data Obtained From Impact on Diabetes App-Related Text Messages From Health Care Professionals in Conjunction With a New Wireless Glucose Meter With a Color Range Indicator Improves Glycemic Control in Patients With Type 1 and Type 2 Diabetes: Randomized Controlled Trial¹¹ and Impact on Diabetes Self-Management and Glycemic Control of a New Color-Based SMBG Meter.¹⁷

	Baseline		24 weeks
	Meter only	Meter + app	Meter only	Meter + app
Age now
All participants	45.1 years	44.0 years	45.1 years	44.0 years
T2DM	56.7 years	54.3 years	56.7 years	54.3 years
Diabetes duration
All participants	16.7 years (17)		17.1 years (17)
T2DM	13 years (13)	11.8 years (12)	13 years (13)	11.8 years (12)
HbA1c
All participants	8.89% 73.66 mmol/mol	8.85% 73.22 mmol/mol	8.33% 67.54 mmol/mol	8.19% 66.01 mmol/mol
T2DM	8.91% 73.88 mmol/mol	8.87% 73.44 mmol/mol	8.28% 66.99 mmol/mol	7.95% 63.39 mmol/mol
Systolic blood pressure	139 mmHg		139 mmHg
Total cholesterol	198 mg/dl		193 mg/dl
HDL cholesterol	46.4 mg/dl		46.8 mg/dl

Cost Calculations

Severe Hypoglycemia (SHE)

It has been reported that severe hypoglycemic events with medical assistance or hospitalization due to unconsciousness or consciousness occur at a rate of 0.19 events per patient per year (0.16 events per patient per year for France).^26,27 Including a 5% and 10% reduction of severe hypoglycemia, annual savings per patient per year were calculated:

5% reduction of severe hypoglycemia:

$$\begin{array}{l}SHE\overline{x}cost/year\times 5\%\times occurancerate=SHE\overline{x}\\ savingpatient/year\end{array}$$

10% reduction of severe hypoglycemia:

$$\begin{array}{l}SHE\overline{x}cost/year\times 10\%\times occurancerate=SHE\overline{x}\\ savingpatient/year\end{array}$$

Myocardial Infraction (MI)

Based on the reduction of the 10-year risk of fatal and nonfatal MI and the treatment cost of MI in insulin-treated diabetes patients the annual savings were calculated per year and per patient per year

$$\begin{array}{l}\left(\%reductionfatalMI\times MI\overline{x}cost/year\right)+\\ \left(\%reductionnon-fatalMI\overline{x}cost/year\right)\\ =MI\overline{x}savings/year\end{array}$$

$$\frac{\overline{x}savingpatientyear}{Noofinsulintreatedpatients}=MI\overline{x}savingspatient/year$$

Annual Savings for Health Care System (HCS)

Annual savings due to reduced MI risk added to savings for a 5% and 10% reduction of severe hypoglycemic events were multiplied by overall number of insulin-treated diabetes patients.

$$\begin{array}{l}\left(MI\overline{x}savings\frac{patient}{year}+SHE\overline{x}saving\frac{patient}{year}\right)\\ \times Noinsulin-treateddiabetes\\ patients=annualsavingfortheHCS\end{array}$$

Results

Risk Assessment by the UKPDS Risk Engine

According to the UKPDS risk engine, an HbA1c reduction of 0.56% in the meter only and 0.66% in the meter + app group after 24 weeks in the overall population of the study was estimated to result in a 10-year risk reduction of 1.1% of fatal MI. No difference between the meter only and meter + app group could be observed with regard to risk reduction of fatal MI (Table 3).

Table 3.

UKPDS Risk Engine⁵³ Assessment With Patient Data From Table 2.

	All participants
	Baseline		24 weeks
	Meter only	Meter + app	Meter only	Meter + app
CHD / MI	13.3%	12.5%	11.9%	11.1%
Fatal CHD / MI	8.6%	7.9%	7.5%	6.8%
Stroke	3.2%	2.9%	3.1%	2.8%
Fatal stroke	0.5%	0.4%	0.5%	0.4%
	T2DM
	Baseline		24 weeks
	Meter only	Meter + app	Meter only	Meter + app
CHD / MI	22.8%	19.8%	20.4%	17.1%
Fatal CHD / MI	16.3%	13.4%	14.3%	11.1%
Stroke	7.1%	5.5%	7.0%	5.5%
Fatal stroke	1.1%	0.8%	1.0%	0.8%

Focusing on the T2DM participants of the study, an HbA1c reduction of 0.63% was observed in the meter only group, whereas participants of the meter + app group had an HbA1c reduction of 0.92%. This was associated with a reduction of fatal MI in the next 10 years of 2.0% in the meter only group and of 2.3% in the meter + app group (Table 3).

Looking at all participants of the RCT no between group difference in MI risk reduction was observed. Thus the economic analysis focused on assessing the impact of a 1.1% risk reduction of fatal MI in the next 10 years for both groups.

For participants with T2DM, a comparison of meter only and meter + app group could highlight the impact of telemedicine on glycemic control.

Economic Analysis for All Participants

Improving glycemic control could positively influence risk of diabetes related cardiovascular events. Estimating the costs for fatal and nonfatal MIs in insulin-treated patients in five different European countries revealed the potential savings for all insulin-treated patients to be €250 553 in France, €4.1 million in Germany, €2.8 million in Italy, €381 140 in Spain, and €191 985 in the United Kingdom. A hypothetical reduction of severe hypoglycemic events by 5% or 10% which is generally suggested to be associated with an improved glycemic control would increase the potential cost savings. In France €10.9 million (5%) or €21.7 million were estimated to be saved by the local health care system. In Germany €33.7 million (5%) or €63.3 million (10%), in Italy €18.9 million (5%) or €34.9 million (10%), in Spain €15.4 million (5%) or €30.4 million (10%), and in the United Kingdom €5.4 million (5%) or €10.5 million (10%) of cost savings for the health care system were estimated (Table 4). In total, the use of a GM with CRI could result in a substantial saving for the 5 European countries, up to €60 million, over 10 years.

Table 4.

Cost Savings per Patient Related to an Improvement in HbA1c of 0.56% to 0.66% in 5 European Countries (All Participants).

Country	France		Germany		Italy		Spain		UK
Annual cost savings per patient
	5%	10%	5%	10%	5%	10%	5%	10%	5%	10%
Hypothetical reduction in severe hypoglycemic episodes	€15.81	€31.62	€12.85	€25.71	€18.62	€37.23	€13.01	€26.01	€6.72	€13.45
Reduction in fatal and nonfatal myocardial infarction	€0.37	€0.37	€1.80	€1.80	€3.21	€3.21	€0.33	€0.33	€0.25	€0.25
In total	€16.18	€31.99	€14.65	€27.51	€21.83	€40.45	€13.34	€26.35	€6.97	€13.70
Annual savings for the health care system
Insulin-treated patients	677 170		2.3 million		864 000		1 154 970		767 418
MI	€250 553		€4.1 million		€2.8 million		€381 140		€191 985
In total	€10.9 million	€21.7 million	€33.7 million	€63.3 million	€18.9 million	€34.9 million	€15.4 million	€30.4 million	€5.4 million	€10.5 million

Currency exchange rate £1 = €1.1271 (October 2018).

Economic Analysis for T2DM

For T2DM participants the risk assessment with regard to fatal MI in the next 10 years suggested a greater risk reduction of 2.3% in the meter + app group rather than 2.0% in the meter only group.

France

These estimated risk reductions could increase the cost savings per patient per year in France from €0.93 to €1.07. Translating this to all insulin-treated T2DM patients in France cost savings could be €456 277 in the meter only group and €524 661 in the meter + app group. Adding cost savings resulting from a reduced event rate in hypoglycemia values increase to €8.2 million in the meter only group and €8.3 million in the meter + app group (5% reduction of severe hypoglycemia) or €16.0 million and €16.1 million, respectively (10% reduction of severe hypoglycemia) (Table 5).

Table 5.

Cost Savings per Patient in 5 European Countries Related to an Improvement in HbA1c Comparing Meter Only and Meter + App Group (T2DM).

Country		France				Germany				Italy
Annual cost savings per patient
		5%		10%		5%		10%		5%		10%
		Meter only	Meter + app	Meter only	Meter + app	Meter only	Meter + app	Meter only	Meter + app	Meter only	Meter + app	Meter only	Meter + app
Hypothetical reduction in severe hypoglycemic episodes		€15.81	€15.81	€31.62	€31.62	€12.85	€12.85	€25.71	€25.71	€18.62	€18.62	€37.23	€37.23
Reduction in fatal and nonfatal myocardial infarction		€0.93	€1.07	€0.93	€1.07	€3.94	€4.53	€3.94	€4.53	€7.49	€8.61	€7.49	€8.61
In total		€16.74	€16.88	€32.55	€32.69	€16.79	€17.38	€29.64	€30.24	€26.10	€27.23	€44.72	€45.84
Annual savings for the health care system
Insulin-treated T2DM patients		492 170				1.91 million				674 000
MI	Meter only	€456 277				€7.5 million				€5.1 million
	Meter + app	€524 661				€8.7 million				€5.8 million
In total		€8.2 million	€8.3 million	€16.0 million	€16.1 million	€32.1 million	€33.2 million	€56.6 million	€57.8 million	€17.6 million	€18.4 million	€30.1 million	€30.9 million

Country		Spain				UK
Annual cost savings per patient
		5%		10%		5%		10%
		Meter only	Meter + app	Meter only	Meter + app	Meter only	Meter + app	Meter only	Meter + app
Hypothetical reduction in severe hypoglycemic episodes		€13.01	€13.01	€26.01	€26.01	€6.72	€6.72	€13.45	€13.45
Reduction in fatal and nonfatal myocardial infarction		€0.80	€0.91	€0.80	€0.91	€0.88	€1.01	€0.88	€1.01
In total		€13.80	€13.92	€26.81	€26.93	€7.60	€7.73	€14.33	€14.46
Annual savings for the health care system
Insulin-treated T2DM patients		882 014				398 467
MI	Meter only	€701 499				€349 064
	Meter + app	€806 724				€401 423
In total		€12.2 million	€12.3 million	€23.7 million	€23.8 million	€3.0 million	€3.1 million	€5.7 million	€5.8 million

Currency exchange rate £1 = €1.1271 (October 2018).

Germany

When analyzing the cost savings for Germany the cost savings could be as follows: €3.94 per patient per year in the meter only group and €4.53 per patient per year in the meter + app group for cost savings due to reduction of fatal MI. Calculated for all insulin-treated T2DM patients in Germany cost savings could be €7.5 million for the meter only group and €8.7 million for the meter + app group. In combination with a 5% risk reduction in hypoglycemic episodes €32.1 million in the meter only and €33.2 million in the meter + app group, and with a 10% risk reduction in hypoglycemic events €56.6 million in the meter only and €57.8 million in the meter + app group monetary savings could be expected (Table 5).

Italy

Italy has 674 000 insulin-treated T2DM patients. Potential cost savings for the Italian health care system due to the utilization of a GM with CRI either alone or in combination with an app could range from €5.1 million to €5.8 million, focusing on estimated reductions of fatal MI. Per patient per year €7.49 and €8.61 could potentially be saved. Suggesting a 5% or 10% risk reduction of severe hypoglycemia accompanying the improved glycemic control could increase cost savings to €17.6 million (5%, meter only), €18.4 million (5%, meter + app), €30.1 million (10%, meter only), and €30.9 million (10%, meter + app) (Table 5).

Spain

In Spain cost savings per patient per year as a result of decreasing risk of MI in the next 10 years in the meter only group were estimated to be €0.80 comparing to €0.91 in the meter + app group. Scaled for all insulin-treated T2DM patients in Spain, cost savings were calculated to be €701 499 for the meter only group and €806 724 for the meter + app group. Combining these monetary savings with savings from a reduction in hypoglycemic events by either 5% or 10% increases numbers as follows: €12.2 million (5%, meter only), €12.3 million (5%, meter + app), €23.7 million (10%, meter only), and €23.8 million (10%, meter + app) (Table 5).

United Kingdom

Similarly to Spain, cost savings per patient per year range from €0.88 to €1.01 regarding both groups for a reduction in fatal MI. Looking at all insulin-treated T2DM patients in the UK cost savings were calculated to be €349 064 in the meter only group and €401 423 in the meter + app group. The hypothetical reduction of severe hypoglycemic events by 5% or 10% added to total cost savings of €3.0 million (5%, meter only), €3.1 million (5%, meter + app), €5.7 million (10%, meter only), and €5.8 million (10%, meter + app) (Table 5).

Effect of Age Adjustment on Risk Assessment

The population of the RCT published by Grady and colleagues represented both T1DM and T2DM patients with a mean age of 45 years and a diabetes duration of 17 years. Focusing on participants with T2DM a shorter diabetes duration of around 12 years was observed compared to the overall population of the study. With regard to age, the T2DM participants had a mean age of 55 years. To investigate the potential impact of a higher age on risk for MI and stroke the risk assessment with the UKPDS risk engine was repeated by adjusting the age to 65 years. This 10-year difference highly increases the risk for both fatal and nonfatal MI and stroke. Comparing meter only and meter + app group a risk reduction of 3.9% was estimated when both GM with CRI and telemedical technologies were integrated into diabetes management (Table 6). Cost estimated for older T2DM patients showed an increase in numbers compared to younger T2DM patients as represented in the study (Figure 2).

Table 6.

Impact on Risk Assessment and Cost Savings of Adjusting Age of the Trial Population to 65 Years.

	T2DM (65 years)
	Baseline		24 weeks
	Meter only	Meter + app	Meter only	Meter + app
CHD / MI	33.9%	33.3%	30.7%	29.1%
Fatal CHD / MI	26.7%	25.9%	23.7%	25.3%
Stroke	14.2%	13.6%	14.0%	13.4%
Fatal stroke	2.1%	2.0%	2.1%	2.0%

Figure 2.

Cost savings for insulin-treated T2DM patients with a mean age of 55 years compared to patients with a mean age of 65 years. Mean age of the T2DM population was adjusted from 55 years to 65 years for UKPDS risk assessment. The pronounced reduction of 10-year risk of having an MI translates into higher cost savings for the health care systems of France, Germany, Italy, Spain, and the United Kingdom. These savings can be observed in both groups using glucose meter with CRI with and without the app. Currency exchange rate £1 = €1.1271 (October 2018).

Discussion

The results from a RCT testing telemedicine intervention using a GM with CRI (OneTouch Verio Flex) alone or in combination with a mobile app (OneTouch Reveal) were integrated into a cost-effectiveness analysis.¹¹ Annual costs savings for health care systems of five European countries were calculated, differentiating between the overall study population and participants with T2DM.

The RCT reported a decrease in HbA1c from 8.87% to 7.95% (73.44 mmol/mol to 63.39 mmol/mol) in participants with T2DM using both GM with CRI and the mobile app, which was associated with a 2.3% reduction of MI in 10 years according to risk assessments with the UKPDS risk engine. Combining the 2.3% reduction of MI with a 10% reduction in severe hypoglycemic episodes annual cost savings for all insulin-treated T2DM patients in France could be €16.1 million, whereas in Germany, Italy, Spain, and the United Kingdom cost savings could be €57.8 million, €30.9 million, €23.8 million, and €5.8 million, respectively. Not only improved glycemic control in participants using both the GM with CRI and mobile app but also in participants solely utilizing the GM with CRI appeared to result in substantial cost savings for the French, German, Italian, Spanish, and British health care systems: €16.0 million, €56.6 million, €30.1 million, €23.7 million, and €5.7 million, respectively (including a 10% risk reduction in hypoglycemic events).

These findings indicate the positive impact of switching insulin-treated patients to a GM with CRI, as all participants were experienced in SMBG before entering the study. Additional benefit came from managing data obtained from blood glucose measurements with an associated mobile app, thus showing that incorporation of telemedicine into diabetes management can improve health care outcomes. This economic analysis presents substantial monetary savings for the health care systems in Europe by providing insulin-treated patients with GM with CRI and enabling improved diabetes management by patients and HCPs with the help of a mobile app.

Similarly to the RCT by Grady and colleagues, a recent meta-analysis of 55 RCTs could show a decrease in HbA1c by 0.48% when improving SMBG using telemedical intervention in patients with diabetes. A subgroup analysis revealed an even higher reduction of HbA1c in patients with T2DM.⁵⁶ Furthermore, existing evidence suggest that with telemedical intervention higher costs reduction may occur due to less or shorter regular visits to the endocrinologist.⁵⁷ GM with CRI in combination with mobile apps are an optimal solution in digitalized health care systems, where smartphones are expected to be used by 70% to 90% of the world’s population by 2020.⁵⁸

Differences in cost savings are likely due to heterogeneity in terms of costs of treatment of MI and hypoglycemic episodes. Average costs of hypoglycemic episodes may be influenced by the health care resources, organization within countries and of individual patients as for example the decentralization of a health care system.⁵⁹ In addition, different treatments of MI could influence costs in different countries. For example some countries, such as Germany and Italy, are more likely to perform a percutaneous coronary intervention, which is not as cost-effective as a thrombolysis, thus resulting in higher cost and subsequently higher savings in this economic analysis.^60,61 A further aspect that should be kept in mind when comparing the results of the economic analysis, is the varying number of insulin-treated patients in the five European countries: Germany (1.91 million) and Spain (882 014) have relatively high numbers of insulin-treated T2DM patients.^19,21,23 In Germany, the high rate of insulin prescription in T2DM could be a result of regulatory institutions impeding availability of alternative glucose-lowering medication and insurances gaining from insulin-treated patients—as was discussed by the IGES institute in 2012.⁶²

The mean age of the study population of the RCT by Grady and colleagues was 45 years, with around 40% T2DM patients with a mean age of 55 years.¹¹ In 2008/2009, 50% of people with newly diagnosed T2DM were 45-64 years old, and in general it is recommended to screen for T2DM in people 45 years and older.^63,64 To get insight into cost savings for older T2DM patients we performed the UKPDS risk assessment adjusting the age to 65 years. The estimated 10-year risk for fatal and nonfatal MI and stroke in 65 year old patients is highly increased compared to 55 year old patients (Table 6). Cost savings accompanying risk reduction mediated through a GM with CRI and the mobile app appeared to be much greater for the older population (Figure 2). With regard to the increasing prevalence of diabetes in people aged 65-99 years—which is estimated to be 122.8 million in 2017 and 253.4 million in 2045—the impact of improved glycemic control on cost savings becomes all the more important.⁶⁵

Limitations

Although the data were included based on existing studies an regional reports the analysis has limitations: the RCT by Grady et al had a relatively small sample size¹¹ and values for blood pressure and lipid levels were retrieved from another study population investigating GM with CRI.¹⁷ This analysis is limited to health care system perspective excluding societal perspective.

Conclusion

The results of the RCT of use of GM with CRI (OneTouch Verio Flex) and with or without mobile app (OneTouch Reveal) resulted in substantial annual cost savings for the five investigated European countries—France, Germany, Italy, Spain, and the United Kingdom. The results stress the importance of improvement in glycemic control based on better diabetes self-management to reduce substantial health care costs. This analysis may aid health care decision making and insurance companies by allowing the costs of insulin therapies to be balanced with the savings provided by diabetes self-management programs with the inclusion of telemedical interventions.