Long-term health economic benefits of sensor-augmented pump therapy vs continuous subcutaneous insulin infusion alone in type 1 diabetes: a UK perspective

Aims/hypothesis:

Continuous subcutaneous insulin infusion (CSII) is an important treatment option for type 1 diabetes patients unable to achieve adequate glycemic control with multiple daily injections (MDI). Combining CSII with continuous glucose monitoring (CGM) in sensor-augmented pump therapy (SAP) with a low glucose-suspend (LGS) feature may further improve glycemic control and reduce the frequency of hypoglycemia. A cost-effectiveness analysis of SAP?+?LGS vs CSII plus self-monitoring of blood glucose (SMBG) was performed to determine the health economic benefits of SAP?+?LGS in type 1 diabetes patients using CSII in the UK.

Methods:

Cost-effectiveness analysis was performed using the CORE diabetes model. Treatment effects were sourced from the literature, where SAP?+?LGS was associated with a projected HbA_1c reduction of ?1.49% vs ?0.62% for CSII, and a reduced frequency of severe hypoglycemia. The time horizon was that of patient lifetimes; future costs and clinical outcomes were discounted at 3.5% and 1.5% per annum, respectively.

Results:

Projected outcomes showed that SAP?+?LGS was associated with higher mean quality-adjusted life expectancy (17.9 vs 14.9 quality-adjusted life years [QALYs], SAP?+?LGS vs CSII), and higher life expectancy (23.8 vs 21.9 years), but higher mean lifetime direct costs (GBP 125,559 vs GBP 88,991), leading to an incremental cost-effectiveness ratio (ICER) of GBP 12,233 per QALY gained for SAP?+?LGS vs CSII. Findings of the base-case analysis remained robust in sensitivity analyses.

Conclusions/interpretation:

For UK-based type 1 diabetes patients with poor glycemic control, the use of SAP?+?LGS is likely to be cost-effective compared with CSII plus SMBG.     

Costs of managing severe hypoglycaemia in three European countries

Abstract

Objectives: To assess the costs of severe hypoglycaemic events (SHEs) in diabetes patients in Germany, Spain and the UK.

Methods: Healthcare resource use was measured by surveying 639 patients aged ≥16 years, receiving insulin for type 1 (n=319) or type 2 diabetes (n=320), who experienced ≥1 SHE in the preceding year. Patients were grouped by location of SHE treatment: group 1, community (family/domestic); group 2, community (healthcare professional); group 3, hospital. Costs were calculated from published unit costs applied to estimated resource use. Costs per SHE were derived from patient numbers per subgroup. Weighted average costs were derived using a prevalence database.

Results: Hospital treatment was a major cost in all countries. In Germany and Spain, costs per SHE for type 1 patients differed from those for type 2 patients in each group. Average SHE treatment costs were higher for patients with type 2 diabetes (Germany, €533; Spain, €691; UK, €537) than type 1 diabetes patients (€441, €577 and €236, respectively). Telephone calls, visits to doctors, blood glucose monitoring and patient education contributed substantially to costs for non-hospitalised patients.

Conclusions: Treatment of SHEs adds significantly to healthcare costs. Average costs were lower for type 1 than for insulin-treated type 2 diabetes, in all three countries.     

Management of severe hypoglycaemia: cultural similarities,differences and resource consumption in three European countries

Abstract

Background: To investigate the characteristics of people with insulin-treated diabetes, who have experienced severe hypoglycaemic events (SHEs), in Germany, Spain or UK.

Methods: Patients with type 1 (n=319) or insulin-treated type 2 diabetes (n=320) who had experienced ≥1 SHE in the preceding year were enrolled. Their median age was 53 years (range, 16–94 years). Data were collected using a questionnaire administered by an experienced interviewer.

Results: The median number of reported SHEs was 2–3 in 12 months. Most events (69%) occurred at home, usually during the day or evening (74%) and most commonly due to insufficient food consumption (45%). In patients whose hypoglycaemia awareness was tested, 68% had normal awareness. Patients requiring emergency healthcare treatment frequently had impaired hypoglycaemia awareness, and developed hypoglycaemic coma more often. Hospital treatment was usually provided in an emergency department (72–94%). The duration of stay was longest in Germany. Following a SHE, patients receiving professional treatment were more likely to: consult their physician, test their blood glucose more often, adjust insulin dose and receive self-management training.

Conclusions: This survey of diabetes patients aged 16–94 years showed that SHEs represent a substantial burden on national healthcare systems in Germany, UK and Spain. The pattern of occurrence and treatment was similar in all three countries, despite differences in cultures and healthcare systems.     

Understanding the economic,daily functioning,and diabetes management burden of non-severe nocturnal hypoglycemic events in Canada: differences between type 1 and type 2

Objective:

To examine the daily functioning, diabetes management, and economic burden of non-severe nocturnal hypoglycemic events (NSNHEs) in Canada and differences in impacts by diabetes type.

Research design and methods:

A 20-min web-based survey, with items derived from the literature, expert and patient interviews, assessing the impact of NSNHEs, was administered to patients with self-reported diabetes aged ≥18 having an NSNHE in the past month.

Results:

Two thousand, two hundred and seventy-nine Canadian persons with diabetes were screened with 200 respondents meeting criteria and included in the analysis sample. Out of 87 working respondents, 15 reported on average 3.5?h of lost work (absenteeism). The reduction in work productivity (presenteeism) reported was comparable to the impact of arthritis. Other functional impacts included sleep and daily activities. Additionally, respondents’ increased their usual blood sugar monitoring practice, on average, 4.2 (SD?=?7.5) extra tests were conducted in the week following the event and reduced their insulin over the following 4.8 days. Increased healthcare utilization was also reported. Increased costs as a result of NSNHE for lost work productivity, increased diabetes management, and resource utilization was CAD 70.67 per person per year in this sample. Limitations of the study include the biases which are associated with a web-based survey and self-reported data.

Conclusions:

NSNHEs have serious consequences for patients and diabetes management practices. Greater attention to treatments which reduce NSNHEs can have a major impact on improving functioning while reducing the economic burden of diabetes.     

The impact of non-severe hypoglycemic events on daytime function and diabetes management among adults with type 1 and type 2 diabetes

Abstract

Objectives:

To describe daytime non-severe hypoglycemic events (NSHEs), assess their impact on patient functioning and diabetes self-management, and examine if these impacts differ by diabetes type or country.

Methods:

Internet survey to adults with diabetes in the US, UK, Germany, and France.

Results:

Of 6756 screened respondents, 2439 reported a daytime NSHE in the past month. NSHEs occurred while active (e.g., running errands) (45.1%), 29.6% while not active (e.g., watching TV), and 23.8% at work. On average, it took half a day to respond and recover from NSHE. Respondents monitored their glucose 5.7 extra times on average over the following week. On the day of event, type 1 respondents tested significantly more often than type 2 (p?<?0.05). Type 2 were less likely to confirm NSHE with glucose test (p?<?0.001). Following NSHE, 12.6% of respondents reduced total insulin by an average of 7.6 units (SD?=?8.3). Total units and days with reduced dosing was significantly less, whilst number of additional glucose tests and time to recover was significantly longer if NSHE occurred at work (p?<?0.001). Type 1 decreased insulin doses more often (p?<?0.001); however, type 2 decreased a greater number of units (p?<?0.01). Compared with other countries, US respondents were more likely to eat a light or full meal and respondents in France took significantly longer than all other countries to recognize (p?<?0.05), respond to (p?<?0.001), and recover from (p?<?0.001) NSHE, used significantly more monitoring tests the day of (p?<?0.05) and over the subsequent week (p?<?0.001), and decreased their normal insulin dose more (p?<?0.001). Limitations of the study include potential recall bias and selection bias.

Conclusions:

NSHEs are associated with a significant impact on patient functioning and diabetes management.     

Cost-utility of exenatide once weekly compared with insulin glargine in patients with type 2 diabetes in the UK

Abstract

Objective:

To compare the cost-utility of exenatide once weekly (EQW) and insulin glargine in patients with type 2 diabetes in the United Kingdom (UK).

Research design and methods:

The IMS CORE Diabetes Model was used to project clinical and economic outcomes for patients with type 2 diabetes treated with EQW or insulin glargine. Treatment effects and patient baseline characteristics (mean age: 58 years, mean glycohaemoglobin: 8.3%) were taken from the DURATION-3 study. Unit costs and health state utility values were derived from published sources. As the price of EQW is not yet known, the prices of two currently available glucagon-like peptide-1 products were used as benchmarks. To reflect diabetes progression, patients started on EQW switched to insulin glargine after 5 years. The analysis was conducted from the perspective of the UK National Health Service over a time horizon of 50 years with costs and outcomes discounted at 3.5%. Sensitivity analyses explored the impact of changes in input data and assumptions and investigated the cost utility of EQW in specific body mass index (BMI) subgroups.

Main outcome measures:

Incremental cost-effectiveness ratio (ICER) for EQW compared with insulin glargine.

Results:

At a price equivalent to liraglutide 1.2?mg, EQW was more effective and more costly than insulin glargine, with a base case ICER of £10,597 per quality-adjusted life-year (QALY) gained. EQW was associated with an increased time to development of any diabetes-related complication of 0.21 years, compared with insulin glargine. Three BMI subgroups investigated (<30, 30–35 and >35?kg/m²) reported ICERs for EQW compared with insulin glargine ranging from £9425 to £12,956 per QALY gained.

Conclusions:

At the prices investigated, the cost per QALY gained for EQW when compared with insulin glargine in type 2 diabetes in the UK setting, was within the range normally considered cost effective by NICE. Cost effectiveness in practice will depend on the final price of EQW and the extent to which benefits observed in short-term randomised trials are replicated in long-term use.     

Evaluation of the cost-utility of insulin degludec vs insulin glargine in Sweden

Abstract

Objective:

To evaluate the annual cost-utility of insulin degludec compared with glargine in patients with: type 1 diabetes (T1D), type 2 diabetes receiving basal-only therapy (T2D-BOT), and type 2 diabetes receiving basal-bolus therapy (T2B-BB) in Sweden.

Methods:

A cost-utility model was programmed in Microsoft Excel to evaluate clinical and economic outcomes. The clinical trials were designed as treat-to-target, with insulin doses adjusted in order to achieve similar glycemic control between treatments, thus long-term modeling is not meaningful. Basal and bolus insulin doses, incidence of hypoglycemic events, frequency of self-monitoring of blood glucose, and possibility for flexibility in timing of dose administration were specified for each insulin in three diabetes populations, based on data collected in Swedish patients with diabetes and a meta-analysis of clinical trials with degludec. Using these characteristics, the model estimated costs from a societal perspective and quality-adjusted life years (QALYs) in the two scenarios.

Results:

Use of degludec was associated with a QALY gain compared with glargine in T1D (0.31 vs 0.26?QALYs), T2D-BOT (0.76 vs 0.69?QALYs), and T2D-BB (0.56 vs 0.47?QALYs), driven by reduced incidence of hypoglycemia and possibility for flexibility around timing of dose administration. Therapy regimens containing degludec were associated with increased costs compared to glargine-based regimens, driven by the increased pharmacy cost of basal insulin, but partially offset by other cost savings. Based on estimates of cost and clinical outcomes, degludec was associated with incremental cost-effectiveness ratios of SEK 19,766 per QALY gained, SEK 10,082 per QALY gained, and SEK 36,074 per QALY gained in T1D, T2-BOT, and T2-BB, respectively.

Limitations:

The hypoglycemic event rates in the base case analysis were derived from a questionnaire-based study that relied on patient interpretation and recall of hypoglycemic symptoms. The relative rates of hypoglycemia with degludec compared to glargine were derived from a meta-analysis of phase III trials, which may not reflect the relative rates observed in real-world clinical practice. Both of these key limitations were explored in one-way sensitivity analyses.

Conclusions:

Based on reduced incidence of hypoglycemia and possibility for flexibility around timing of dose administration, use of degludec is likely to be cost-effective compared to glargine from a societal perspective in T1D, T2-BOT, and T2-BB in Sweden over a 1-year time horizon.     

Reduced medical spending associated with increased use of a remote diabetes management program and lower mean blood glucose values

Abstract

Aims: Many new mobile technologies are available to assist people in managing chronic conditions, but data on the association between the use of these technologies and medical spending remains limited. As the available digital technology offerings to aid in diabetes management increase, it is important to understand their impact on medical spending. The aim of this study was to investigate the financial impact of a remote digital diabetes management program using medical claims and real-time blood glucose data.

Materials and methods: A retrospective analysis of multivariate difference-in-difference and instrumental variables regression modeling was performed using data collected from a remote digital diabetes management program. All employees with diabetes were invited, in a phased introduction, to join the program. Data included blood glucose (BG) values captured remotely from members via connected BG meters and medical spending claims. Participants included members (those who accepted the invitation, n?=?2,261) and non-members (n?=?8,741) who received health insurance benefits from three self-insured employers. Medical spending was compared between people with well-controlled (BG ≤ 154?mg/dL) and poorly controlled (BG > 154?mg/dL) diabetes.

Results: Program access was associated with a 21.9% (p?<?0.01) decrease in medical spending, which translates into a $88 saving per member per month at 1 year. Compared to non-members, members experienced a 10.7% (p?<?0.01) reduction in diabetes-related medical spending and a 24.6% (p?<?0.01) reduction in spending on office-based services. Well-controlled BG values were associated with 21.4% (p?=?0.03) lower medical spending.

Limitations and conclusions: Remote digital diabetes management is associated with decreased medical spending at 1 year. Reductions in spending increased with active utilization. It will be beneficial for future studies to analyze the long-term effects of the remote diabetes management program and assess impacts on patient health and well-being.     

A cost comparison of long-acting insulin analogs vs NPH insulin-based treatment in patients with type 2 diabetes using routinely collected primary care data from the UK

Abstract

Aim:

The aim of this analysis was to investigate total healthcare costs, HbA1c, and weight changes over a 36-month period in patients with type 2 diabetes initiated on NPH or long-acting insulin analogs.

Methods:

Electronic patient data from 479 general practices in the UK (THIN database) were examined for new users of glargine (n?=?794), detemir (n?=?252), or NPH insulin (n?=?430). Annualized healthcare costs and clinical outcomes in years 1, 2, and 3 following insulin initiation were quantified and compared with baseline, using ANOVA and linear regression models.

Results:

A significant difference (p?<?0.05) in total healthcare costs increases at year 1 vs baseline was observed between glargine and detemir, detemir and NPH, but not between glargine and NPH (increase: +£486, +£635, and +£420 for glargine, detemir, and NPH users, respectively). However, increases by year 3 were not significantly different between the insulins. A propensity score analysis comparing analog and NPH insulin showed that, following insulin initiation, increases in costs were higher with insulin analogs at year one (+£220), but this difference decreased over time in each year following insulin initiation (+£168 and +£146, respectively, for years 2 and 3). HbA1c reductions were not significantly different between the groups at all time points. Differences in weight gain between glargine and NPH were statistically significant at year 1 (0.87?kg vs 1.11?kg) and year 3 (1.15?kg vs 1.57?kg), but other estimates of between-group differences in weight gain were non-significant.

Conclusions:

Following insulin initiation, the difference in healthcare costs of long-acting analogs compared to NPH insulin was transient. By year 3, the cost differences were not significantly different between the two cohorts, driven by an observed reduction in the cost of self-monitoring of blood glucose (SMBG) in the analog group and an increase in the cost of bolus insulin in the NPH group.     

Comparison of treatment costs in inadequately controlled type 2 diabetes in Germany based on the APOLLO trial with insulin glargine

Abstract

Objective: A cost analysis of once-daily insulin glargine versus three-times daily insulin lispro in combination with oral antidiabetic drugs (OADs) for insulin-naive type 2 diabetes patients in Germany based on the APOLLO trial (A Parallel design comparing an Oral antidiabetic drug combination therapy with either Lantus once daily or Lispro at mealtime in type 2 diabetes patients failing Oral treatment).

Methods: Annual direct treatment costs were estimated from the perspective of the German statutory health insurance (SHI). Costs accounted for included insulin medication, disposable pens and consumable items (needles, blood glucose test strips and lancets). Sensitivity analyses (on resource use and unit costs) were performed to reflect current German practice.

Results: Average treatment costs per patient per year in the base case were €1,073 for glargine and €1,794 for lispro. Insulin costs represented 65% vs. 37% of total costs respectively. Acquisition costs of glargine were offset by the lower costs of consumable items (€380 vs. €1,139). Sensitivity analyses confirmed the robustness of the results in favour of glargine. All scenarios yielded cost savings in total treatment costs ranging from €84 to €727.

Conclusions: Combination therapy of once-daily insulin glargine versus three-times daily insulin lispro both with OADs, in the management of insulin-dependent type 2 diabetes offers the potential for substantial cost savings from the German SHI perspective.     

An indirect treatment comparison of the efficacy of insulin degludec/liraglutide (IDegLira) and insulin glargine/lixisenatide (iGlarLixi) in patients with type 2 diabetes uncontrolled on basal insulin

Aims: To obtain estimates of the relative treatment effects between insulin degludec/liraglutide (IDegLira) and insulin glargine U100/lixisenatide (iGlarLixi) in patients with type 2 diabetes mellitus (T2DM) uncontrolled on basal insulin therapy.

Materials and methods: Data from phase 3 trials providing evidence for estimating the relative efficacy and safety of IDegLira vs iGlarLixi in patients uncontrolled on basal insulin-only regimens were used in this analysis. Outcomes of interest were changes in HbA_1c, body weight and insulin dose, and rate ratio of hypoglycemia. The indirect comparison of the reported trial findings followed the principles of Bucher et al.

Results: IDegLira was estimated to provide a 0.44 [95% CI?=?0.17–0.71] %-point reduction in HbA_1c compared with iGlarLixi. Body weight was reduced by 1.42 [95% CI?=?0.35–2.50] kg with IDegLira compared with iGlarLixi. Insulin dose was comparable between the two interventions. The rate of severe or blood glucose-confirmed (self-measured plasma glucose [SMPG]?≤?3.1?mmol/L) hypoglycemia with IDegLira was approximately half that of iGlarLixi (rate ratio?=?0.51 [95% CI?=?0.29–0.90]). However, using the American Diabetes Association definition of documented symptomatic hypoglycemia (SMPG ≤3.9?mmol/L) the rate was comparable between the two treatments (rate ratio?=?1.07 [95% CI?=?0.90–1.28]).

Limitations: The assumptions made in the indirect comparison and differences between the included trials in baseline HbA_1c levels, previous use of sulfonylureas, definitions of hypoglycemia, presence or absence of run-in period, the different duration of the trials, and the cross-over design of one of the trials.

Conclusions: The results of this indirect treatment comparison demonstrate that, among patients with T2DM uncontrolled on basal insulin, treatment with IDegLira results in a greater reduction of HbA_1c and a greater reduction in body weight compared with iGlarLixi at similar insulin doses.     

Long-term cost-effectiveness of insulin detemir versus NPH insulin in type 2 diabetes in Sweden

Abstract

Aim:

To evaluate the cost-effectiveness of insulin detemir vs. NPH insulin once daily, in patients with type 2 diabetes in the Swedish setting based on clinical data from a published randomized controlled trial.

Methods:

Projections of long-term outcomes were made using the IMS CORE Diabetes Model (CDM), based on clinical data from a 26-week randomized controlled trial that compared once daily insulin detemir and NPH insulin, when used to intensify insulin treatment in 271 patients with type 2 diabetes and body mass index (BMI) 25–40?kg/m². Trial results showed that insulin detemir was associated with a significantly lower incidence of hypoglycemic events and significantly less weight gain in comparison with NPH insulin. The analysis was conducted from a third party payer perspective and the base case analysis was performed over a time horizon of 40 years and future costs and clinical outcomes were discounted at a rate of 3% per year.

Results:

Insulin detemir was associated with higher mean (SD) quality-adjusted life expectancy (5.42 [0.10] vs. 5.31 [0.10] quality-adjusted life years [QALYs]) and lower overall costs (SEK 378,539 [10,372] vs. SEK 384,216 [11,230]; EUR 33,794 and EUR 34,300, respectively, where 1 EUR?=?11.2015 SEK) compared with NPH insulin. Sensitivity analysis showed that the principal driver of the benefits associated with insulin detemir was the lower rate of hypoglycemic events (major and minor events) vs. NPH insulin, suggesting that detemir might also be cost-saving over a shorter time horizon. Limitations of the analysis include the use of data from a trial outside Sweden in the Swedish setting.

Conclusions:

Based on clinical input data derived from a previously published randomized controlled trial, it is likely that in the Swedish setting insulin detemir would be cost-saving in comparison with NPH insulin for the treatment of patients with type 2 diabetes.     

Resource utilisation and costs in patients with type 2 diabetes mellitus treated with insulin glargine or conventional basal insulin under real-world conditions in Germany: LIVE-SPP study

Objective: To assess and compare the total costs relevant to diabetes care in patients with type 2 diabetes mellitus (T2D) treated at specialised diabetes practices with either insulin glargine- or conventional basal insulin (neutral protamine Hagedorn [NPH])-based therapies from the German statutory health insurance (SHI) perspective.

Methods: The Long Acting Insulin Glargine Versus NPH Cost Evaluation in Specialised Practices (LIVE-SPP) study is an observational, retrolective, multicentre longitudinal cost comparison in adults with T2D. Costs were evaluated from the German SHI perspective based on official 2005 prices. Average total costs per patient for insulin glargine-versus NPH-based therapies were compared using multivariate general linear modelling. Sensitivity analyses were performed by varying the main cost factors by ± 25%.

Results: Patients (n=1,024, 512 patients per cohort) were on average 62 years of age, with an average 8-year diabetes history at study start. The average unadjusted total annual costs per patient were €1,868.41 (95% CI 1,744.27–1,992.56) for insulin glargine-based vs. €2,063.72 (95% CI 1,922.91–2,204.54) for NPH-based therapies. Average adjusted total annual costs per patient between insulin glargine- (€1,241.13) and NPH-based therapies (€1,607.86) were statistically significantly different (p=0.0004). The economic advantage for insulin glargine-based therapies resulted mainly from fewer blood glucose measurements and other diabetes-related materials (e.g. needles). The savings remained stable in one-way sensitivity analyses.

Conclusions: The LIVE-SPP study suggests that insulin glargine-based therapies may offer an economic advantage over NPH-based therapies.     

Comparison of utilization,cost, adherence,and hypoglycemia in patients with type 2 diabetes initiating rapid-acting insulin analog with prefilled pen versus vial/syringe

Abstract

Background:

Studies examining outcomes of different insulin delivery systems are limited. The objective of this study was to compare healthcare utilization, costs, adherence, and hypoglycemia rates in patients with type 2 diabetes mellitus (T2DM) initiating rapid-acting insulin analog (RAIA) using prefilled pen versus vial/syringe.

Methods:

A retrospective analysis was conducted using a US claims database (1/1/2007 to 12/31/2008). Inclusion criteria were: ≥18 years old, with T2DM, ≥12 months of continuous eligibility, and new to RAIA. Difference-in-difference analyses after propensity score matching were conducted to compare changes in outcomes from 6 months prior to and 6 months after initiating RAIA with a prefilled pen versus vial/syringe (Wilcoxon rank-sum test for costs and t-test for other outcomes). Categories of utilization and costs (2009 USD) included total and diabetes-related inpatient, outpatient, and emergency room. Adherence was measured by proportion of days covered (PDC). Hypoglycemia was identified using ICD-9-CM codes.

Results:

Baseline characteristics were similar between the prefilled pen (n?=?239) and vial/syringe (n?=?590) cohorts after matching. Adherence to RAIA was greater in the prefilled pen cohort than the vial/syringe cohort (PDC: 54.6 vs. 45.2%, p?<?0.001). While the increase in diabetes-related pharmacy costs from before to after initiating RAIA was greater in the prefilled pen cohort than the vial/syringe cohort (+$900 vs. +$607, p?<?0.001), the prefilled pen cohort was associated with greater reductions in the total diabetes-related costs (–$235 vs. +$61, p?=?0.006) and the utilization of oral anti-hyperglycemic agents (–1.3 vs. –0.7, p?=?0.016). There were no significant differences in other outcomes.

Limitations:

Claims databases do not provide optimal measures for adherence or T2DM severity, and only capture hypoglycemia events requiring clinical intervention.

Conclusion:

Initiating RAIA with a prefilled pen was associated with better adherence and greater reduction in total diabetes-related costs than a vial/syringe. There was no significant difference in total healthcare costs.     

Impact of nocturnal hypoglycemic events on diabetes management,sleep quality,and next-day function: results from a four-country survey

Abstract

Objectives:

Non-severe nocturnal hypoglycemic events (NSNHEs) may have a major impact on patients. The objective was to determine how NSNHEs affect diabetes management, sleep quality, functioning, and to assess if these impacts differ by diabetes type or country.

Methods:

An internet survey to adults with diabetes in the US, UK, Germany, and France.

Results:

Of 6756 screened respondents, 1086 reported an NSNHE in the past month. For this last event, respondents with type 2 required significantly more time than type 1 to recognize and respond to the event (1.5 vs 1.1 hours), 25.7% (T1) and 18.5% (T2) decreased their normal insulin dose due to their most recent NSNHE. All respondents were likely to take 1–2 additional self-monitored blood glucose measurements on the day following. NSNHEs were associated with a high proportion of respondents contacting a healthcare professional (18.6% T1, 27.8% T2) reporting they could not return to sleep at night (13.3% T1, 13.4% T2), and tiredness on the day following the event (71.2% for both). Of the respondents working for pay, 18.4% T1 and 28.1% T2 reported being absent from work due to the NSNHE, and a substantial proportion of respondents (8.7% T1, 14.4% T2) also reported missing a meeting or work appointment or not finishing a task on time. Compared with other countries, respondents from France may experience a more substantial impact on diabetes management and daily functioning following an NSNHE. Potential limitations in this study include recall and selection bias; however, these biases are not believed to have impacted findings in any meaningful way.

Conclusions:

NSNHEs are associated with a substantial impact on diabetes management, sleep quality, and next-day functioning.     

Cost-effectiveness of insulin detemir compared with NPH insulin in people with type 2 diabetes in Denmark,Finland, Norway,and Sweden

Abstract

Objective:

To assess the cost-effectiveness of insulin detemir compared with Neutral Protamine Hagedorn (NPH) insulin when initiating insulin treatment in people with type 2 diabetes mellitus (T2DM) in Denmark, Finland, Norway, and Sweden.

Methods:

Efficacy and safety data were derived from a 20-week multi-centre randomized controlled head-to-head clinical trial comparing insulin detemir and NPH insulin in insulin naïve people with T2DM, and short-term (1-year) cost effectiveness analyses were performed. As no significant differences in HbA_1c were observed between the two treatment arms, the model was based on significant differences in favour of insulin detemir in frequency of hypoglycaemia (Rate-Ratio?=?0.52; CI?=?0.44–0.61) and weight gain (Δ?=?0.9?kg). Model outcomes were measured in Quality Adjusted Life Years (QALYs) using published utility estimates. Acquisition costs for insulin and direct healthcare costs associated with non-severe hypoglycaemic events were obtained from National Health Service public sources. One-way and probabilistic sensitivity analyses were performed.

Results:

Based on lower incidence of non-severe hypoglycaemic events and less weight gain, the QALY gain from initiating treatment with insulin detemir compared with NPH insulin was 0.01 per patient per year. Incremental cost-effectiveness ratios for the individual countries were: Denmark, Danish Kroner 170,852 (€22,933); Finland, €28,349; Norway, Norwegian Kroner 169,789 (€21,768); and Sweden, Swedish Krona 226,622 (€25,097) per QALY gained. Possible limitations of the study are that data on hypoglycaemia and relative weight benefits from a clinical trial were combined with hypoglycaemia incidence data from observational studies. These populations may have slightly different patient characteristics.

Conclusions:

The lower risk of non-severe hypoglycaemia and less weight gain associated with using insulin detemir compared with NPH insulin when initiating insulin treatment in insulin naïve patients with type 2 diabetes provide economic benefits in the short-term. Based on cost/QALY threshold values, this represents good value for money in the Nordic countries. Using a short-term modelling approach may be conservative, as reduced frequency of hypoglycaemia and less weight gain may also have positive long-term health-related implications.     

Resource use in patients hospitalized with complicated skin and soft tissue infections in Europe and analysis of vulnerable groups: the REACH study

Background:

Hospitalized patients with complicated skin and soft tissue infections (cSSTI) present a substantial economic burden, and resource use can vary according to the presence of comorbidities, choice of antibiotic agent, and the requirement for initial treatment modification. REACH (NCT01293435) was a retrospective, observational study aimed at collecting empirical data on current (year 2010–2011) management strategies of cSSTI in 10 European countries.

Methods:

Patients (n?=?1995) were aged ≥18 years, hospitalized with a cSSTI and receiving intravenous antibiotics. Data, collected via electronic Case Report Forms, detailed patient characteristics, medical history, disease characteristics, microbiological diagnosis, disease course and outcomes, treatments before and during hospitalization, and health resource consumption.

Results:

For the analysis population, mean length of hospital stay (including duration of hospitalizations for patients with recurrences) was 18.5 days (median 12.0). Increased length of hospital stay was found for patients with comorbidities vs those without (mean?=?19.9; [median?=?14.0] days vs 13.3 [median?=?8.0] days), for patients with methicillin-resistant Staphylococcus aureus compared with patients with methicillin-sensitive S. aureus (mean?=?27.7 [median?=?19.5] days vs 18.4 [median?=?13.0] days) and for patients requiring surgery (mean?=?24.4 [median?=?16.0] days vs 15.0 [median?=?11.0] days). Patients requiring modification of their initial antibiotic treatment had an associated increase in mean length of hospital stay of 10.9 days (median?=?6.5) and additional associated hospital resource use. A multivariate analysis confirmed the association of nosocomial infections, comorbidities, directed treatment, recurrent infections, diabetes, recent surgery, and older age (≥65 years), with longer hospital stay.

Conclusions:

This study provides real-life data on factors that are expected to impact length of hospital stay, to guide clinical decision-making to improve outcomes, and reduce resource use in patients with cSSTI.