Objective: To establish the prevalence of patient-reported hypoglycemia among ambulatory patients with diabetes and assess its impact on health-related quality of life (HRQoL).Methods: This study was a cross-sectional analysis of a postal survey disbursed during quarter 1 of 2010 to 875 adults with type 1 or 2 diabetes identified on the basis of an index clinical encounter for diabetes management between August 1, 2005 and June 30, 2006. The survey included questions about hypoglycemia, self-rating of health, and questions adapted from the Confidence in Diabetes Self-Care, Generalized Anxiety Disorder-7, EuroQol5-D, and Hypoglycemic Fear Survey. Data was analyzed using two sample t-test for continuous and Chi-square for categorical variables, with multivariate analysis to adjust for age, gender, diabetes duration, and Charlson comorbidity index.Results: The survey was completed by 418 patients (47.8% response rate). Of the respondents, 26 of 92 (28.3%) with type 1 and 55 of 326 (16.9%) with type 2 diabetes reported at least one episode of severe hypoglycemia within 6 months. Fear of hypoglycemia, including engagement in anticipatory avoidance behaviors, was highest in patients with type 2 diabetes reporting severe hypoglycemia and all patients with type 1 diabetes (p < 0.001). HRQoL was lower in patients with type 2, but not type 1, diabetes reporting severe hypoglycemia (p < 0.01).Conclusion: Clinicians and health systems should incorporate screening for hypoglycemia into routine health assessment of all patients with diabetes. It places patients at risk for counterproductive behaviors, impairs HRQoL, and should be used in individualizing glycemic goals.
[Show abstract][Hide abstract] ABSTRACT: Health-related quality of life (HRQoL) measures have been increasingly used in economic evaluations for policy guidance. We investigate the impact of 11 self-reported long-standing health conditions on HRQoL using the EQ-5D in a UK sample.
We used data from 13,955 patients in the South Yorkshire Cohort study collected between 2010 and 2012 containing the EQ-5D, a preference-based measure. Ordinary least squares (OLS), Tobit and two-part regression analyses were undertaken to estimate the impact of 11 long-standing health conditions on HRQoL at the individual level.
The results varied significantly with the regression models employed. In the OLS and Tobit models, pain had the largest negative impact on HRQoL, followed by depression, osteoarthritis and anxiety/nerves, after controlling for all other conditions and sociodemographic characteristics. The magnitude of coefficients was higher in the Tobit model than in the OLS model. In the two-part model, these four long-standing health conditions were statistically significant, but the magnitude of coefficients decreased significantly compared to that in the OLS and Tobit models and was ranked from pain followed by depression, anxiety/nerves and osteoarthritis.
Pain, depression, osteoarthritis and anxiety/nerves are associated with the greatest losses of HRQoL in the UK population. The estimates presented in this article should be used to inform economic evaluations when assessing health care interventions, though improvements can be made in terms of diagnostic information and obtaining longitudinal data.
The European Journal of Health Economics 01/2014; 16(2). DOI:10.1007/s10198-013-0559-z · 2.10 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background: Closed-loop insulin delivery is a promising option to improve glycaemic control and reduce the risk of hypoglycaemia. We aimed to assess whether overnight home use of automated closed-loop insulin delivery would improve glucose control. Methods: We did this open-label, multicentre, randomised controlled, crossover study between Dec 1, 2012, and Dec 23, 2014, recruiting patients from three centres in the UK. Patients aged 18 years or older with type 1 diabetes were randomly assigned to receive 4 weeks of overnight closed-loop insulin delivery (using a model-predictive control algorithm to direct insulin delivery), then 4 weeks of insulin pump therapy (in which participants used real-time display of continuous glucose monitoring independent of their pumps as control), or vice versa. Allocation to initial treatment group was by computer-generated permuted block randomisation. Each treatment period was separated by a 3-4 week washout period. The primary outcome was time spent in the target glucose range of 3·9-8·0 mmol/L between 0000 h and 0700 h. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01440140.
[Show abstract][Hide abstract] ABSTRACT: Background:
Clinical experience of patients is an additional source of information that can inform prescribing decisions for new therapies in practice. In diabetes, for example, patients with recurrent hypoglycemia may be excluded from trials conducted for regulatory purposes. Using insulin degludec (IDeg), a new basal insulin with an ultra-long duration of action as an example, an interim analysis is presented describing whether the decision to prescribe IDeg to patients experiencing treatment-limiting problems on their existing insulin regimes represented good clinical and economic value.
Records from the first 51 consecutive patients with diabetes (35 type 1 [T1D] and 16 type 2 [T2D]) switching to insulin degludec from either insulin glargine (IGlar) or insulin detemir (IDet), mostly due to problems with hypoglycemia (39/51, 76.5%), were reviewed at up to 37 weeks. Patients indicated frequency of hypoglycemia and completed a disease-specific questionnaire reporting six measures of confidence and treatment satisfaction. For the largest group of exposed patents, the T1D module of the IMS Core Diabetes Model (CDM) was used to evaluate the cost-effectiveness of the treatment decision.
HbA1c decreased by 0.5 ± 0.3% points and 0.7 ± 0.3% points for T1D and T2D, respectively. Hypoglycemic events decreased by >90%. Combined mean scores were ≥ 3.7 (1 = much worse, 3 = no change, 5 = much improved) for all six satisfaction and confidence items. In T1D, the treatment decision was highly cost-effective in the CDM lifetime analysis. Even when excluding benefits beyond hypoglycemia reduction, predicted cost per quality-adjusted life-year for IDeg vs IGlar/IDet was £10,754.
These data illustrate the complementary nature of clinical trial and practice data when evaluating the value of therapeutic innovations in diabetes care. There were reductions in patient-reported hypoglycemia, reduced HbA1c, and improved treatment satisfaction in relation to the decision to prescribe IDeg. Initial health economic evaluation suggested that the decision to prescribe IDeg in this phenotypic group of T1D patients represented good value for money.
Journal of Medical Economics 10/2014; 18(2):1-27. DOI:10.3111/13696998.2014.975234 · 1.58 Impact Factor
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