Accuracy, Utilization, and Effectiveness Comparisons of Different Continuous Glucose Monitoring Systems.

BACKGROUND: Accuracy and feature sets of continuous glucose monitoring (CGM) systems may influence device utilization and outcomes. We compared clinical trial accuracy and real-world utilization and effectiveness of two different CGM systems. MATERIALS AND METHODS: Separately conducted accuracy studies of a fifth-generation and a sixth-generation CGM system involved 50 and 159 adults, respectively. For between-system performance comparisons, propensity score methods were utilized to balance cohort characteristics. Real-world outcomes were assessed in 10,000 anonymized patients who had switched from the fifth-generation to the sixth-generation system and had used connected mobile devices to upload data from both systems, allowing pairwise comparisons of device utilization and glucose concentration distributions. RESULTS: Propensity score-adjusted mean absolute relative differences for the fifth- and sixth-generation systems were 9.0% and 9.9%, and the percentages of values within ±20%/20 mg/dL were 93.1% and 92.5%, respectively. The sixth-generation system, but not the fifth-generation system, met accuracy criteria for interoperable CGM systems. Both systems had high real-world utilization rates (93.8% and 95.3% in the fifth- and sixth-generation systems, respectively). Use of the sixth-generation system was associated with fewer glucose values <55 mg/dL (<3.1 mmol/L) (0.7% vs. 1.1%, P < 0.001) and more values 70-180 mg/dL (3.9-10.0 mmol/L) (57.3% vs. 56.0%, P < 0.001) than the fifth-generation system. CONCLUSIONS: CGM performance outcomes can be compared through the propensity score analysis of clinical trial data and pairwise comparisons of real-world data. The systems compared here had nearly equivalent accuracy and utilization rates. Longer term biochemical and psychosocial benefits observed with the fifth-generation system are also expected with the sixth-generation system.

Continuous Glucose Monitoring Use in Type 1 Diabetes: Longitudinal Analysis Demonstrates Meaningful Improvements in HbA1c and Reductions in Health Care Utilization.

BACKGROUND: Real-time continuous glucose monitoring (rtCGM) improves glycemic control in type 1 diabetes (T1D) patients treated with continuous subcutaneous insulin infusion (CSII). However, the benefits of rtCGM in T1D patients treated with multiple daily insulin injection (MDI) therapy has not been well studied. We explored the effects of rtCGM versus self-monitoring of blood glucose (SMBG) on clinical outcomes within a large T1D population treated with either CSII or MDI therapy. METHODS: This retrospective, longitudinal analysis utilized datasets from T1D patients enrolled in a commercial health plan to assess changes in HbA1c in 187 naïve to rtCGM users and 6260 SMBG users. Propensity score modeling was used to assess inpatient admissions, emergency room (ER) visits in 1130 patients (565 rtCGM, 565 SMBG). Differences in HbA1c reduction (rtCGM+MDI vs rtCGM+CSII) were evaluated. RESULTS: Larger, clinically meaningful HbA1c reductions were seen among rtCGM versus SMBG users: -0.5% ( P = .004) versus -0.2% ( P < .0001); 0.3% diff in diff, P = .03. All-cause inpatient admissions were lower for rtCGM users: -42%, P = .013. Emergency room visits coded for diabetic ketoacidosis (DKA) were four times higher for SMBG patients than rtCGM patients: 17 versus 4, P = .0318. HbA1c reductions were most notable with rtCGM+MDI versus rtCGM+CSII treatment: -0.6% ( P = .01) versus -0.3% ( P = .16). CONCLUSIONS: Use of rtCGM in T1D patients facilitates greater HbA1c improvements and reduced health care system utilization compared with traditional SMBG use regardless of insulin administration method. Treatment with rtCGM in conjunction with MDI confers similar or greater glycemic benefits without the additional costs associated with CSII therapy.

Cost-effectiveness of G5 Mobile continuous glucose monitoring device compared to self-monitoring of blood glucose alone for people with type 1 diabetes from the Canadian societal perspective.

AIMS: To evaluate the cost-effectiveness of real-time continuous glucose monitoring (CGM) compared to self-monitoring of blood glucose (SMBG) alone in people with type 1 diabetes (T1DM) using multiple daily injections (MDI) from the Canadian societal perspective. METHODS: The IMS CORE Diabetes Model (v.9.0) was used to assess the long-term (50 years) cost-effectiveness of real-time CGM (G5 Mobile CGM System; Dexcom, Inc., San Diego, CA) compared with SMBG alone for a cohort of adults with poorly-controlled T1DM. Treatment effects and baseline characteristics of patients were derived from the DIAMOND randomized controlled clinical trial; all other assumptions and costs were sourced from published research. The accuracy and clinical effectiveness of G5 Mobile CGM is the same as the G4 Platinum CGM used in the DIAMOND randomized clinical trial. Base case assumptions included (a) baseline HbA1c of 8.6%, (b) change in HbA1c of -1.0% for CGM users vs -0.4% for SMBG users, and (c) disutilities of -0.0142 for non-severe hypoglycemic events (NSHEs) and severe hypoglycemic events (SHEs) not requiring medical intervention, and -0.047 for SHEs requiring medical resources. Treatment costs and outcomes were discounted at 1.5% per year. RESULTS: The incremental cost-effectiveness ratio for the base case G5 Mobile CGM vs SMBG was $33,789 CAD/quality-adjusted life-year (QALY). Sensitivity analyses showed that base case results were most sensitive to changes in percentage reduction in hypoglycemic events and disutilities associated with hypoglycemic events. The base case results were minimally impacted by changes in baseline HbA1c level, incorporation of indirect costs, changes in the discount rate, and baseline utility of patients. CONCLUSIONS: The results of this analysis demonstrate that G5 Mobile CGM is cost-effective within the population of adults with T1DM using MDI, assuming a Canadian willingness-to-pay threshold of $50,000 CAD per QALY.

Continuous Glucose Monitoring and Global Reimbursement: An Update.

Real-time continuous glucose monitoring has been available for a decade and reimbursement for the technology has been slowly growing. Reasons for the various rates of reimbursement and adoption are explored in this article and the status of country-wide reimbursement is discussed.

Continuous Glucose Monitoring in Older Adults With Type 1 and Type 2 Diabetes Using Multiple Daily Injections of Insulin: Results From the DIAMOND Trial.

OBJECTIVE: The objective was to determine the effectiveness of real-time continuous glucose monitoring (CGM) in adults ≥ 60 years of age with type 1 (T1D) or type 2 (T2D) diabetes using multiple daily insulin injections (MDI). METHODS: A multicenter, randomized trial was conducted in the United States and Canada in which 116 individuals ≥60 years (mean 67 ± 5 years) with T1D (n = 34) or T2D (n = 82) using MDI therapy were randomly assigned to either CGM (Dexcom™ G4 Platinum CGM System® with software 505; n = 63) or continued management with self-monitoring blood glucose (SMBG; n = 53). Median diabetes duration was 21 (14, 30) years and mean baseline HbA1c was 8.5 ± 0.6%. The primary outcome, HbA1c at 24 weeks, was obtained for 114 (98%) participants. RESULTS: HbA1c reduction from baseline to 24 weeks was greater in the CGM group than Control group (-0.9 ± 0.7% versus -0.5 ± 0.7%, adjusted difference in mean change was -0.4 ± 0.1%, P < .001). CGM-measured time >250 mg/dL ( P = .006) and glycemic variability ( P = .02) were lower in the CGM group. Among the 61 in the CGM group completing the trial, 97% used CGM ≥ 6 days/week in month 6. There were no severe hypoglycemic or diabetic ketoacidosis events in either group. CONCLUSION: In adults ≥ 60 years of age with T1D and T2D using MDI, CGM use was high and associated with improved HbA1c and reduced glycemic variability. Therefore, CGM should be considered for older adults with diabetes using MDI.

Exercise management in type 1 diabetes: a consensus statement.

Type 1 diabetes is a challenging condition to manage for various physiological and behavioural reasons. Regular exercise is important, but management of different forms of physical activity is particularly difficult for both the individual with type 1 diabetes and the health-care provider. People with type 1 diabetes tend to be at least as inactive as the general population, with a large percentage of individuals not maintaining a healthy body mass nor achieving the minimum amount of moderate to vigorous aerobic activity per week. Regular exercise can improve health and wellbeing, and can help individuals to achieve their target lipid profile, body composition, and fitness and glycaemic goals. However, several additional barriers to exercise can exist for a person with diabetes, including fear of hypoglycaemia, loss of glycaemic control, and inadequate knowledge around exercise management. This Review provides an up-to-date consensus on exercise management for individuals with type 1 diabetes who exercise regularly, including glucose targets for safe and effective exercise, and nutritional and insulin dose adjustments to protect against exercise-related glucose excursions.

An Economic Evaluation of Continuous Glucose Monitoring for People with Type 1 Diabetes and Impaired Awareness of Hypoglycaemia within North West London Clinical Commissioning Groups in England.

To assess the economic impact of providing real time continuous glucose monitoring (CGM) for people with type 1 diabetes (T1D) and impaired awareness of hypoglycaemia (IAH) within North West (NW) London clinical commissioning groups (CCGs). METHODS: The eligible population for CGM and inputs for the economic budget impact model developed were derived from published data. The model includes cost of CGM; cost savings associated with lower hypoglycaemia related hospital admissions, accidents and emergency visits; self-monitoring of blood glucose (SMBG) strip usage; and glycated haemoglobin (HbA1c) reduction-related avoided complications and insulin pump use. RESULTS: The cost of CGM for T1D-IAH (n=3,036) in the first year is £10,770,671 and in the fourth year is £11,329,095. The combined cost off-sets related to reduced hypoglycaemia admissions, SMBG strip usage and complications are £8,116,912 and £8,741,026 in years one and four, respectively. The net budget impact within the NW London CCGs is £2,653,760; £2,588,068 in years one and four respectively. CONCLUSIONS: Introduction of CGM for T1D-IAH patients will have a minimal budget impact on NW London CCGs, driven by cost of CGM and offsets from lower hypoglycaemia-related costs, reduced SMBG strip usage, avoided HbA1c-related complications and lower insulin pump use.

The Potential Cost Implications of Averting Severe Hypoglycemic Events Requiring Hospitalization in High-Risk Adults With Type 1 Diabetes Using Real-Time Continuous Glucose Monitoring.

BACKGROUND: Severe hypoglycemia remains a major barrier to optimal diabetes management and places a high burden on the US health care system due to the high costs of hypoglycemia-related emergency visits and hospitalizations. Patients with type 1 diabetes (T1DM) who have hypoglycemia unawareness are at a particularly high risk for severe hypoglycemia, the incidence of which may be reduced by the use of real-time continuous glucose monitoring (RT-CGM). METHODS: We performed a cost calculation using values of key parameters derived from various published sources to examine the potential cost implications of standalone RT-CGM as a tool for reducing rates of severe hypoglycemia requiring hospitalization in adult patients with T1DM who have hypoglycemia unawareness. RESULTS: In a hypothetical commercial health plan with 10 million members aged 18-64 years, 9.3% (930 000) are expected to have diagnosed diabetes, with approximately 5% (46 500) having T1DM, of whom approximately 20% (9300) have hypoglycemia unawareness. RT-CGM was estimated to reduce the cost of annual hypoglycemia-related hospitalizations in this select population by $54 369 000, yielding an estimated net cost savings of $8 799 000 to $12 519 000 and a savings of $946 to $1346 per patient. CONCLUSION: This article presents a cost calculation based on available data from multiple sources showing that RT-CGM has the potential to reduce short-term health care costs by averting severe hypoglycemic events requiring hospitalization in a select high-risk population. Prospective, randomized studies that are adequately powered and specifically enroll patients at high risk for severe hypoglycemia are needed to confirm that RT-CGM significantly reduces the incidence of these costly events.

The Cost-Effectiveness of Real-Time Continuous Glucose Monitoring (RT-CGM) in Type 2 Diabetes.

BACKGROUND: This analysis models the cost-effectiveness of real-time continuous glucose monitoring (RT-CGM) using evidence from a randomized controlled trial (RCT) that demonstrated RT-CGM reduced A1C, for up to 9 months after using the technology, among patients with type 2 diabetes not on prandial insulin. RT-CGM was offered short-term and intermittently as a self-care tool to inform patients' behavior. METHOD: The analyses projected lifetime clinical and economic outcomes for RT-CGM versus self-monitoring of blood glucose by fingerstick only. The base-case analysis was consistent with the RCT (RT-CGM for 2 weeks on/1 week off over 3 months). A scenario analysis simulated outcomes of an RT-CGM "refresher" after the active intervention of the RCT. Analyses used the IMS CORE Diabetes Model and were conducted from a US third-party payer perspective, including direct costs obtained from published sources and inflated to 2011 US dollars. Costs and health outcomes were discounted at 3% per annum. RESULTS: Life expectancy (LE) and quality-adjusted life expectancy (QALE) from RT-CGM were 0.10 and 0.07, with a cost of $653/patient over a lifetime. Incremental LE and QALE from a "refresher" were 0.14 and 0.10, with a cost of $1312/patient over a lifetime, and incremental cost-effectiveness ratios were $9319 and $13 030 per LY and QALY gained. CONCLUSIONS: RT-CGM, as a self-care tool, is a cost-effective disease management option in the US for people with type 2 diabetes not on prandial insulin. Repeated use of RT-CGM may result in additional cost-effectiveness.

Are Systematic Reviews and Meta-Analyses Appropriate Tools for Assessing Evolving Medical Device Technologies?

Systematic reviews and meta-analyses (SRMAs) provide unique insights into comparative effectiveness of diabetes treatments. However, use of these analyses may be inappropriate for assessing the value and utility of technologies that involve significant behavioral interventions and encompass rapidly evolving technologies such as real-time continuous glucose monitoring (RT-CGM). The rapid evolution of RT-CGM, compared with the time required for publication of clinical studies used in SRMAs, may preclude differentiation between past and current generations of devices. In addition, the effect of performance and usability differences between the various commercial devices on possible clinical outcomes associated with the devices are often not clearly discussed, and many of the RT-CGM studies assessed in SRMAs do not provide adequate information regarding whether and/or to what degree study subjects and clinicians were trained to use the RT-CGM and utilize the data to adjust therapy. Although numerous clinical studies have shown that the glycemic benefit of RT-CGM is related to the frequency and duration of use, a disproportionate number of RT-CGM studies included in recent SRMAs are based on the results of the intention-to-treat analyses and do not consider this fundamental behavioral component in their conclusions. Given these limitations, the generalizability of SRMA conclusions may be limited, and findings from these reports may significantly underestimate the potential glycemic benefit of current and future devices, posing challenges for coverage and reimbursement. We reviewed the potential limitations of the recent Cochrane Collaboration report on CGM, focusing on the 12 studies that assessed RT-CGM use in adults, children/adolescents or both.

HypoDE: Research Design and Methods of a Randomized Controlled Study Evaluating the Impact of Real-Time CGM Usage on the Frequency of CGM Glucose Values <55 mg/dl in Patients With Type 1 Diabetes and Problematic Hypoglycemia Treated With Multiple Daily Injections.

Systems for continuous glucose monitoring (CGM) have been available for a number of years, and numerous clinical studies have been performed with them. Interestingly, in many of these studies patients with an increased risk of hypoglycemic events were excluded. In addition, in most studies subjects were using a pump for insulin delivery. Therefore our knowledge about the benefit of CGM in patients employing multiple daily injections (MDI) of insulin is limited, especially when it comes to a reduction in the risk of low glucose events in high-risk individuals. We are planning to run a 26-week randomized controlled study in Germany (HypoDE, Hypoglycemia in Deutschland) that is focused on evaluating if such a reduction can be observed in patients on MDI with an increased risk of low glucose events. In all, 160 patients will participate in the study, randomized into the intervention group and control group. Ideally one would study if the frequency of severe hypoglycemic events is different between both groups. However, this would require such a large sample size and study duration, so for pragmatic reasons we will use low glucose levels <55 mg/dl (measured by CGM) for at least 20 minutes as a risk marker for severe hypoglycemic events. The results from the HypoDE study shall help determine the advantage of using CGM in subjects with type 1 diabetes with an increased risk of low glucose events treated with MDI.

A cost-effectiveness analysis of continuous subcutaneous insulin injection versus multiple daily injections in type 1 diabetes patients: a third-party US payer perspective.

OBJECTIVE: To estimate the long-term cost-effectiveness of using continuous subcutaneous insulin infusion (CSII) compared with multiple daily injections (MDI) of insulin in adult and child/young adult type 1 diabetes mellitus (T1DM) patients from a third-party payer perspective in the United States. METHOD: A previously validated health economic model was used to determine the incremental cost-effectiveness ratio (ICER) of CSII compared with MDI using published clinical and cost data. The primary input variable was change in HbA(1c), and was assumed to be an improvement of -0.9% to -1.2% for CSII compared with MDI for child/young adult and adults, respectively. A series of Markov constructs simulated the progression of diabetes-related complications. RESULTS: CSII was associated with an improvement in quality-adjusted life-years (QALYs) gained of 1.061 versus MDI for adults and 0.799 versus MDI for children/young adults. ICERs were $16,992 and $27,195 per QALY gained for CSII versus MDI in adults and children/young adults, respectively. Improved glycemic control from CSII led to a lower incidence of diabetes complications, with the most significant reduction in proliferative diabetic retinopathy (PDR), end stage renal disease (ESRD), and peripheral vascular disease (PVD). The number needed to treat (NNT) for PDR was nine patients, suggesting that only nine patients need to be treated with CSII to avoid one case of PDR. The NNT for ESRD and PVD was 19 and 41, respectively. CONCLUSIONS: Setting the willingness to pay at $50,000/QALY, the analysis demonstrated that CSII is a cost-effective option for patients with T1DM in the United States.

Treating diabetes to accepted standards of care: a 10-year projection of the estimated economic and health impact in patients with type 1 and type 2 diabetes mellitus in the United States.

OBJECTIVE: The aim of this study was to investigate the health-economic impact of maintaining glycosylated hemoglobin (HbA(1c)) values in all US patients with currently uncontrolled type 1 or type 2 diabetes mellitus at the American Diabetes Association (ADA) standard of 7.0% and the American Association of Clinical Endocrinologists (AACE) target of 6.5% compared with maintenance at current population-based values. METHODS: The CORE-Center for Outcomes Research Diabetes Model was used to predict costs and outcomes for patients with uncontrolled type 1 and type 2 diabetes who remain at established population mean HbA(1c) values in comparison with those for patients who maintain the standard value of 7.0% or the target value of 6.5%. The analysis was run from a societal perspective over a 10-year time horizon. The costs of treating complications and medication costs were retrieved from published sources. Costs and clinical outcomes were discounted at 3% per annum. Sensitivity analyses were performed on the discount rate and time horizon. RESULTS: This analysis found that maintaining HbA(1c) at the ADA standard value of 7.0% and the AACE target value of 6.5% in patients with uncontrolled type 1 and type 2 diabetes could achieve total direct medical cost savings of nearly 35 US dollars and 50 billion US dollars , respectively, over 10 years. When indirect cost savings were included, the total savings increased to between nearly 50 billion US dollars and 72 billion US dollars for these respective HbA(1c) targets, corresponding to 4% and 6% of the total annual US health care costs of 1.3 trillion US dollars. Reduced savings were observed with a higher discount rate and shorter time horizon, but savings increased as the time horizon became longer. These cost savings must be weighed against the cost of reaching the HbA(1c) goals and the likelihood of achieving the clinical objectives. CONCLUSIONS: Efficient targeting of financial resources toward the goal of lowering HbA(1c) in line with published guidelines could lead to financial savings in the range from nearly 35 billion US dollars to 72 billion US dollars over the next 10 years.