Towards a better understanding of postprandial hyperglycemic episodes in people with diabetes: impact on daily functioning.

OBJECTIVE: Acute postprandial hyperglycemia (aPPHG) is often symptomatic and can be associated with behavioral changes such as impaired working memory and attention. However, there is little evidence of the impact of aPPHG on the daily lives of patients. The aim of this study was to explore the frequency and severity of aPPHG episodes and their impact on daily functioning in people with insulin-treated diabetes. METHODS: Adults (n = 1200) with insulin-treated diabetes mellitus type 1 (T1DM) or 2 (T2DM), most of whom experienced aPPHG, were recruited to complete an online cross-sectional survey in the USA and UK. The survey captured self-reported severity and frequency of aPPHG episodes and included a newly developed questionnaire (aPPHG-Q) assessing the impact of aPPHG episodes on patients' daily lives. Data was analyzed separately according to diabetes type and country. Regression analyses were used to assess the relationship between severity or frequency and scores on the aPPHG-Q. RESULTS: Between 70% and 86% of USA, and 87% and 88% of UK participants reported experiencing aPPHG episodes. Increasing frequency and severity of aPPHG episodes were associated with worse scores on the aPPHG-Q in patients with both T1DM and T2DM in both countries (p < .014) on all subscale scores (excluding the worry and concerns scores for T1DM in the UK), although the magnitude of the association was smaller for aPPHG frequency. CONCLUSIONS: Increased severity and frequency of aPPHG episodes in patients with insulin-treated diabetes is associated with greater burden and experience of symptoms, and can negatively impact daily functioning.

Postprandial glucose and healthcare resource use: a cross-sectional survey of adults with diabetes treated with basal-bolus insulin.

AIMS: Postprandial glucose (PPG) control is a well-known challenge for diabetes management, yet there is limited research on how PPG affects healthcare resource utilization. This study investigated the association between PPG levels and healthcare resource utilization among adults with diabetes treated with basal-bolus insulin. METHODS: A web-based, cross-sectional survey (n = 940) of adults with type 1 or type 2 diabetes and treated with basal and bolus insulins was conducted in Italy, the UK, and the US. Descriptive analyses included frequencies, cross-tabulations, and comparison of means. Incidence-rate ratios (IRR) were calculated using negative binomial regression analysis to investigate the relationship between elevated PPG and healthcare resource utilization. Models controlled for demographic characteristics, duration of diabetes, and diabetes-related complications. RESULTS: Among respondents who measured PPG regularly and reported their two highest PPG values in the past week (n = 691), the mean average highest PPG value was 11.9 mmol/L (SD = 4.0). On average, holding other variables constant at their means, a 1 mmol/L increase in PPG was associated with an increase in healthcare resource utilization related to diabetes and elevated PPG, including the expected number of healthcare provider (HCP) visits in the past 6 months (IRR [95% CI] = 1.14 [1.08-1.21], p < .001), the expected number of calls/emails to HCPs in the past 6 months (IRR [95% CI] = 1.12 [1.06-1.19], p < .001), and the expected number of overnight hospitalizations in the past year (IRR [95% CI] = 1.14 [1.07-1.23], p < .001). LIMITATIONS: The study relied on self-reported data, which may be subject to recall bias. Given the cross-sectional nature of the study, results should be interpreted with caution. CONCLUSIONS: Increased PPG levels were significantly associated with increased healthcare resource utilization among adults with diabetes. Additional education regarding PPG monitoring may help improve the day-to-day management of diabetes and reduce healthcare costs.

Timing of Insulin Injections, Adherence, and Glycemic Control in a Multinational Sample of People with Type 2 Diabetes: A Cross-Sectional Analysis.

INTRODUCTION: We investigated the association of bolus insulin dose timing with demographics, adherence, diabetes education program participation, experience with hypoglycemic events, glycemic control, and patient preference among respondents with type 2 diabetes. METHODS: Adults with type 2 diabetes from 12 countries were recruited to a Web-based self-reported patient preference survey. Adherence was measured using an adapted Morisky Medication Adherence Scale questionnaire. RESULTS: In total 1483 respondents reported using bolus insulin with 58% (n = 864) dosing bolus insulin before meals (pre-meal cohort), 354 (24%) during or after meals (post-meal cohort), and 265 (18%) before, during, or after meals (mixed cohort). The mixed cohort was excluded, thus 1218 respondents were included in the analysis. Respondent distribution across HbA1c category differed significantly depending on insulin dose timing (p = 0.0006); more respondents in the post-meal cohort (40%) had HbA1c ≥ 9% (74.9 mmol/mol) than in the pre-meal cohort (29%). The post-meal cohort was significantly more likely to report non-adherence than the pre-meal cohort (OR = 1.50, p = 0.01) and significantly more often reported participating in diabetes education programs (p < 0.05). Seventy-eight percent of all respondents reported preferring bolus insulin administrable whenever convenient. CONCLUSIONS: Approximately 24% of respondents never comply with guidelines for insulin dose timing, with higher risk of non-adherence and increased participation in diabetes care programs. Respondents dosing insulin post-meal are more likely to have poor glycemic control (HbA1c ≥ 9%, 74.9 mmol/mol). Given that many respondents had high HbA1c and were non-adherent, a treatment which satisfies patient preference for bolus insulin with flexible dose timing could be considered. FUNDING: Novo Nordisk.

Understanding bolus insulin dose timing: the characteristics and experiences of people with diabetes who take bolus insulin.

OBJECTIVE: Despite the increased popularity of newer, fast-acting bolus insulin treatment options that allow for more flexibility in the timing of bolus insulin dosing in recent years, relatively little is known about people with diabetes who administer bolus insulin at differing times in relation to their meals. The purpose of this study was to investigate bolus insulin dose timing in relation to meals among people with type 1 (T1D) and type 2 (T2D) diabetes, as well as to better understand the characteristics and experiences of people who bolus dose at differing times. METHODS: A web-based survey of adults with T1D and T2D treated with bolus insulin therapy in Germany, the UK, and USA was conducted. RESULTS: A total of 906 respondents completed the survey (39% T1D; 61% T2D). A majority of respondents reported bolus dosing before meals in the previous week (57.0%), followed by after meals (18.9%), with meals (12.7%), and at varying times (11.5%). Compared to respondents who dosed with or after meals, those who dosed before meals were significantly less likely to experience hypoglycemia (before, 55.7%; with, 72.8%; after, 68.7%; p < .001) in the previous week. Respondents who bolus dosed before meals were significantly more likely to perceive bolus dose timing as flexible (45.5%) compared to those who dosed with (27.8%) or after (35.7%) meals (p < .001). CONCLUSION: Results show that many people with T1D and T2D dose their bolus insulin with or after meals. Key limitations of all self-report surveys include potential bias in responses and generalizability of findings. However, the study was designed to help mitigate these limitations. The findings have implications for clinicians and suggest opportunities for improving diabetes education and care.

Short-term cost-effectiveness of insulin detemir and insulin aspart in people with type 1 diabetes who are prone to recurrent severe hypoglycemia.

OBJECTIVE: Based on the data of the HypoAna trial (ClinicalTrials.gov NCT00346996), a short-term cost-effectiveness analysis was conducted comparing an all insulin analogue regimen with an all human insulin regimen in people with type 1 diabetes who are prone to recurrent severe hypoglycemia. METHODS: Clinical data from the HypoAna trial and Danish cost data related to the treatment of severe hypoglycemia were used to populate a 1-year cost-effectiveness analysis. Hypoglycemia quality-of-life data were based on previously published utility values, used to calculate the quality-adjusted life-years (QALYs) gained. Sensitivity analyses were conducted to test the robustness of the analysis. The main outcome measure was the incremental cost-effectiveness ratio (ICER). RESULTS: The insulin analogue regimen was associated with greater total costs compared with the human insulin regimen (20,418 DKK [1972 GBP] vs. 18,558 DKK [1793 GBP], respectively), primarily driven by the difference in insulin costs. Total costs for corrective actions for hypoglycemic events, however, were lower in the insulin analogue group (927 DKK [89 GBP]) compared with the human insulin group (1311 DKK [127 GBP]), primarily due to a lower event rate. QALYs were higher with insulin analogues vs. human insulin (difference 0.0672). The resulting ICER was 27,685 DKK (2674 GBP) per QALY gained, which is well below the generally accepted cost-effectiveness threshold. CONCLUSIONS: The analysis shows that treating people with type 1 diabetes who are prone to recurrent severe hypoglycemia with an insulin analogue regimen is cost-effective compared with a human insulin regimen.

Understanding Post-Prandial Hyperglycemia in Patients with Type 1 and Type 2 Diabetes: A Web-based Survey in Germany, the UK, and USA.

INTRODUCTION: To explore how patients with diabetes experience post-prandial hyperglycemia (PPH) or elevated blood glucose (BG) following a meal. METHODS: A web-based survey of patients with type 1 or type 2 diabetes using bolus insulin in Germany, the USA, and the UK was conducted. RESULTS: A total of 906 respondents completed the survey. PPH was a frequent occurrence among patients with type 1 and type 2 diabetes; 61.9% of respondents had experienced PPH in the past week, and differences by diabetes type were not significant. More than half of the respondents reported that they knew they were experiencing PPH because they had measured their BG (64.8%) and/or because they "just didn't feel right" (51.9%). The most frequently reported reasons given for PPH were eating more fat/sugar than estimated (31.2%) and over-eating in terms of their calculated bolus insulin dose (30.4%). The most common situations/factors contributing to PPH were stress (27.4%), eating at a restaurant (24.9%), being busy (21.1%), and/or feeling tired (19.2%). The most frequent corrective actions respondents took following PPH were testing BG and taking bolus insulin based on the reading (62.0%), and/or eating less/more carefully at their next meal or snack (18.8%). Additionally, significant differences in the reasons and contributing factors given for PPH and corrective actions following PPH, as well as emotions experienced when taking bolus insulin, were found by diabetes type. CONCLUSION: These findings shed light on how patients with diabetes experience and manage PPH on a day-to-day basis and have implications for improving diabetes self-management. Clinicians and diabetes educators should help patients address eating habits and lifestyle issues that may contribute to PPH. FUNDING: This study was sponsored by Novo Nordisk.

Patients' with type 2 diabetes willingness to pay for insulin therapy and clinical outcomes.

OBJECTIVES: This study assessed patient preferences, using willingness to pay as a method to measure different treatment characteristics or attributes associated with injectable insulin therapy in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: Adults with type 2 diabetes in 12 countries, diagnosed >6 months prior and receiving insulin for >3 months, were recruited through a representative online panel. Data were collected via online questionnaire and analyzed using a standard choice model for discrete choice experiment. RESULTS: A total of 3758 patients from North America (n=646), South America (n=1537), and Europe (n=1575) completed the study. Mean glycated hemoglobin (HbA1c) levels in North America, South America, and Europe were 63 mmol/mol (7.9%), 75 mmol/mol (9.0%), and 64 mmol/mol (8.0%), respectively. In the three regions, monthly willingness to pay was US$116, US$74, and US$92, respectively, for a 1%-point decrease in HbA1c; US$99, US$80, and US$104 for one less major hypoglycemic event per year; and US$64, US$37 and US$60 for a 3 kg weight decrease. To avoid preinjection preparation of insulin, the respective values were US$47, US$18, and US$37, and US$25, US$25, and US$24 for one less injection per day. Among respondents on basal-only insulin who had previously tried a more intensive regimen, reasons for switching back included difficulty in handling multiple injections and risk of hypoglycemic events. CONCLUSIONS: Reducing HbA1c, frequency of major hypoglycemic events and weight decrease were the highest valued outcomes in each region. The administrative burden of injections was also considered important.

The Economic Burden of Post-prandial Hyperglycemia (PPH) Among People with Type 1 and Type 2 Diabetes in Three Countries.

INTRODUCTION: Post-prandial hyperglycemia (PPH) among people with diabetes is a well-known clinical challenge to diabetes management. While the economic burden of diabetes is well studied, little is known about economic costs specific to PPH. The purpose of this study was to investigate costs of PPH related to work, diabetes management, and use of healthcare resources among people with diabetes taking bolus insulin. METHODS: Data were collected in a web survey of 906 adults with type 1 (39%) and type 2 (61%) diabetes taking bolus insulin in Germany (34%), the UK (26%), and the USA (40%). RESULTS: Sixty-two percent of respondents experienced PPH in the past week, and respondents averaged 1.7 episodes per week. Working respondents indicated that PPH affected their work productivity: 27% missed work time and 71% experienced work productivity issues while at work due to a recent episode of PPH. In terms of diabetes management, respondents with PPH in the past week measured their blood glucose (BG) more frequently than those without PPH (3.7 vs. 2.5 times/day, P < 0.001). PPH was also significantly associated with greater use of healthcare resources. Compared to those without PPH, respondents with PPH reported greater contact with healthcare professionals related to diabetes in the past year (5.5 vs. 4.4 visits, P < 0.001; 2.7 vs. 1.4 calls/emails, P < 0.001) and were more likely to report medical complications related to diabetes (72% vs. 55%, P < 0.001). Average annual costs associated with PPH due to missed work time, additional BG test strips, and physician visits were estimated to be $1239 USD per employed person in the USA. CONCLUSION: Results indicate that PPH is associated with greater economic costs and that reducing the incidence of PPH would help mitigate such costs. Additional research is needed to better understand costs associated with PPH that may be more difficult to measure, as well as more long-term impacts and costs. FUNDING: Novo Nordisk.

Investigating the Evidence of the Real-Life Impact of Acute Hyperglycaemia.

UNLABELLED: Poorly controlled diabetes mellitus (DM) is associated with the development of long-term micro- and macro-vascular complications. The predominant focus of anti-diabetic therapy has been on lowering glycosylated haemoglobin levels, with a strong emphasis on fasting plasma glucose (particularly in Type 2 DM). There is considerable evidence indicating that post-meal hyperglycaemic levels are independently associated with higher risks of macro-vascular disease. Although some have identified mechanisms which may account for these observations, interventions which have specifically targeted postprandial glucose rises showed little or no effect in reducing cardiovascular risk. Clinical experience and some recent studies suggest acute hyperglycaemia affects cognition and other indicators of performance, equivalent to impairment seen during hypoglycaemia. In this brief report, we evaluated the published studies and argue that acute hyperglycaemia is worth investigating in relation to the real-life implications. In summary, evidence exists suggesting that acute hyperglycaemia may lead to impaired cognitive performance and productivity, but the relationship between these effects and daily activities remains poorly understood. Further research is required to enhance our understanding of acute hyperglycaemia in daily life. A better appreciation of clinically relevant effects of acute hyperglycaemia will allow us to determine whether it needs to be addressed by specific treatment. FUNDING: Novo Nordisk A/S Søborg, Denmark.

An analysis of the cost-effectiveness of starting insulin detemir in insulin-naïve people with type 2 diabetes.

AIMS: There is limited evidence with respect to the cost-effectiveness of starting insulin in people with diabetes outside the 'western' world. The aim of this study was to assess the cost-effectiveness of starting basal insulin treatment with insulin detemir in people with type 2 diabetes (T2D) inadequately controlled on oral glucose-lowering drugs (OGLDs) in Mexico, South Korea, India, Indonesia, and Algeria. METHODS: The IMS CORE Diabetes Model was used to project clinical and cost outcomes over a 30-year time horizon. Clinical outcomes, baseline characteristics and health state utility data were taken from the A1chieve study. A 1-year analysis was also conducted based on treatment costs and quality-of-life data. Incremental cost-effectiveness ratios (ICERs) were expressed as a fraction of GDP per capita, and WHO-CHOICE recommendations (ICER < 3.0) used to define cost-effectiveness. RESULTS: Starting insulin detemir was associated with a projected increase in life expectancy (≥1 year) and was considered cost-effective in all of the studied populations with ICERs of -0.02 (Mexico), 0.00 (South Korea), 0.48 (India), 0.12 (Indonesia), and 0.88 (Algeria) GDP/quality-adjusted life-year. Cost-effectiveness was maintained after conducting sensitivity analyses in the 30-year and 1-year analyses. A projected increase in treatment costs was partially offset by a reduction in complications. The difference in overall costs between insulin detemir and OGLDs alone was USD518, 1431, 3510, 15, and 5219, respectively. CONCLUSION: Changes in clinical outcomes associated with starting insulin detemir in insulin-naïve individuals with T2D resulted in health gains that made the intervention cost-effective in five countries with distinct healthcare resources.

An analysis of the cost-effectiveness of switching from biphasic human insulin 30, insulin glargine, or neutral protamine Hagedorn to biphasic insulin aspart 30 in people with type 2 diabetes.

AIMS: The aim of this analysis was to assess the cost-effectiveness of switching from biphasic human insulin 30 (BHI), insulin glargine (IGlar), or neutral protamine Hagedorn (NPH) insulin (all ± oral glucose-lowering drugs [OGLDs]) to biphasic insulin aspart 30 (BIAsp 30) in people with type 2 diabetes in India, Indonesia, and Saudi Arabia. METHODS: The IMS CORE Diabetes Model was used to determine the clinical outcome, costs, and cost-effectiveness of switching from treatment with BHI, IGlar, or NPH to BIAsp 30 over a 30-year time horizon. A 1-year analysis was also performed based on quality-of-life data and treatment costs. Incremental cost-effectiveness ratios (ICERs) were expressed as a fraction of gross domestic product (GDP) per capita, and cost-effectiveness was defined as ICER <3-times GDP per capita. RESULTS: Switching treatment from BHI, IGlar, or NPH to BIAsp 30 was associated with an increase in life expectancy of >0.7 years, reduction in all diabetes-related complications, and was considered as cost-effective or highly cost-effective in India, Indonesia, and Saudi Arabia (BHI to BIAsp 30, 0.26 in India, 1.25 in Indonesia, 0.01 in Saudi Arabia; IGlar to BIAsp 30, -0.68 in India, -0.21 in Saudi Arabia; NPH to BIAsp 30, 0.15 in India, -0.07 in Saudi Arabia; GDP per head per annum/quality-adjusted life-year). Cost-effectiveness was maintained in the 1-year analyses. CONCLUSIONS: Switching from treatment with BHI, IGlar, or NPH to BIAsp 30 (all ± OGLDs) was found to be cost-effective in India, Indonesia, and Saudi Arabia, both in the long and short term.