Insulin degludec versus insulin glargine in type 1 and type 2 diabetes mellitus: a meta-analysis of endpoints in phase 3a trials.

Introduction: Insulin degludec (degludec) is a basal insulin with an ultra-long, stable action profile and reduced pharmacodynamic variability. Seven phase 3a trials compared degludec with insulin glargine (glargine). Patient-level meta-analyses were performed to obtain a comprehensive overview of differences between the insulin preparations, possible because consistent outcome definitions were utilized.

Understanding the economic burden of nonsevere nocturnal hypoglycemic events: impact on work productivity, disease management, and resource utilization.

Objective: Nonsevere hypoglycemic events are common and may occur in one-third of persons with diabetes as often as several times a week. This study's objective was to examine the economic burden of nonsevere nocturnal hypoglycemic events (NSNHEs).

Methods: A 20-minute Web-based survey, with items derived from the literature, expert input, and patient interviews, assessing the impact of NSNHEs was administered in nine countries to 18 years and older patients with self-reported diabetes having an NSNHE in the past month.

Non-severe nocturnal hypoglycemic events: experience and impacts on patient functioning and well-being.

Purpose: Non-severe nocturnal hypoglycemic events (NSNHEs) are hypoglycemic events that occur during sleep but do not require medical assistance from another individual. This study was conducted to better understand the NSNHEs as patients actually experience them in their daily life, and how they impacted functioning and well-being.

Methods: Nine focus groups were held in four countries with diabetics (Type 1 and Type 2) who had experienced an NSNHE within the previous month: France (2 groups); Germany (2 groups); United Kingdom (2 groups); and United States (3 groups).

Cost of Self-Monitoring of Blood Glucose in Canada among Patients on an Insulin Regimen for Diabetes.

Introduction: People with diabetes are at a higher risk of developing a variety of medical conditions relative to those without diabetes, resulting in increased healthcare costs. Self-monitoring of blood glucose (SMBG) is accepted as a recommended element of effective diabetes self-management. However, little is known about the real-world frequency and actual expenditures associated with SMBG, as well as the impact of SMBG costs relative to the cost of diabetes treatments.

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

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.

Cost-effectiveness of switching patients with type 2 diabetes from insulin glargine to insulin detemir in Chinese setting: a health economic model based on the PREDICTIVE study.

Objectives: To evaluate the long-term cost-effectiveness of switching from insulin glargine (IGla) to insulin detemir (IDet) in patients with type 2 diabetes in the setting of Chinese secondary and tertiary hospitals.

Methods: A published and validated computer simulation model of diabetes (the Center for Outcomes Research model) was used to make the long-term (30 years) projection of health economic outcomes. Patient demographic information and clinical end points were derived from a subgroup analysis of the Predictable Results and Experience in Diabetes through Intensification and Control to Target: an International Variability Evaluation (PREDICTIVE) study.

Cost of self-monitoring of blood glucose in the United States among patients on an insulin regimen for diabetes.

Background: People with diabetes are at an increased risk of developing numerous complications, resulting in increased health care expenditures, economic burden, and higher mortality. For patients using an insulin pump or multiple insulin injections, self-monitoring of blood glucose (SMBG) is recognized as a core component of effective diabetes self-management. However, little is known about the real-world frequency and true costs associated with SMBG as a percentage of an insulin regimen in the United States.

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

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.

The impact of non-severe hypoglycemic events on work productivity and diabetes management.

Objectives: Hypoglycemia is a common complication of treatment with certain diabetes drugs. Non-severe hypoglycemic events (NSHEs) occur more frequently than severe events and account for the majority of total events. The objective of this multi-country study was to identify how NSHEs in a working population affect productivity, costs, and self-management behaviors.

Healthcare costs of fast-acting insulin analogues versus short-acting human insulin for Danish patients with type 2 diabetes on a basal-bolus regimen.

Aims: Fast-acting insulin analogues (FAIAs) reduce hypoglycaemia and improve administration flexibility compared with short-acting human insulin (SHI). This analysis examines whether these benefits translate into cost offsets when comparing the total treatment costs for FAIA versus SHI used as basal-bolus therapy for treating type 2 diabetes (T2D).

Methods: Registry data covering the Danish population including demographic variables, prescription, hospital and primary care data formed the basis for analysis.

Examining the ability to detect change using the TRIM-Diabetes and TRIM-Diabetes Device measures.

Purpose: Responsiveness is defined as the ability of an instrument to accurately detect change when it has occurred and is an essential psychometric property of a patient-reported outcomes (PRO) measure to understand and interpret study findings. This study examined the responsiveness of 2 Treatment Related Impact Measures (TRIMs): The TRIM-Diabetes (TRIM-D) and TRIM-Diabetes Device (TRIM-DD) as well as confirmed their measurement models in a randomized controlled trial (RCT) design.

Methods: The data were collected in a multi-center, randomized, open-label (2 × 12 week), cross-over study of two prefilled pens in subjects with type 1 or type 2 diabetes, age 18 or older.

Measuring the health status burden in hemodialysis patients using the SF-36® health survey.

Purpose: The SF-36, a generic measure of 8 domains of health-related quality of life (HRQOL), has been widely used to examine HRQOL of end-stage renal disease (ESRD) patients undergoing hemodialysis (HD). The current study synthesizes existing literature to examine which SF-36 domains capture the largest burden in this patient population.

Methods: A literature search of published studies that presented descriptive statistics for baseline SF-36 scale scores from HD patients was conducted.

Real-life dosage and clinical efficacy of biphasic insulin preparations in patients with type 2 diabetes.

Introduction: This retrospective study used data from a primary care database to compare two insulin products in routine clinical practice for the treatment of type 2 diabetes in the UK.

Patients And Methods: Records were analyzed for patients with type 2 diabetes who had been initiated on biphasic insulin aspart 30 (BIAsp30) (n=632) or biphasic isophane human insulin 30 (BHI30) (n=762) and who had a glycated hemoglobin (HbA₁(c)) measurement at baseline (up to 6 months before the index date) and end of study (6-12 months after index date). Regression analyses were used to test for a statistically significant interaction between reduction in HbA₁(c) from baseline to end of study and the log-transformed average daily dose (logADD) of insulin.

Cost-effectiveness of somatropin for the treatment of short children born small for gestational age.

Background: Short children born small for gestational age (SGA) may be at increased risk for long-term morbidity and reduced health-related quality of life (HRQoL) due to their short stature. Normalization of height in childhood and adolescence is possible in such children via the use of the recombinant human growth hormone somatropin.

Objective: The aim of this study was to determine whether somatropin was a cost-effective treatment option in short children born SGA.

Patient treatment satisfaction after switching to NovoMix® 30 (BIAsp 30) in the IMPROVE™ study: an analysis of the influence of prior and current treatment factors.

Purpose: Understanding treatment satisfaction (TS) for diabetes is increasingly important as treatment options increase. This study examines treatment satisfaction with NovoMix® 30 in an observational study in patients with type 2 diabetes.

Methods: The DiabMedSat assesses Overall, Treatment Burden, Symptom and Efficacy Treatment Satisfaction.

Direct healthcare costs of patients with type 2 diabetes using long-acting insulin analogues or NPH insulin in a basal insulin-only regimen.

Aims: To compare direct healthcare costs incurred by patients with type 2 diabetes in Denmark prescribed long-acting insulin analogues (LAIA) or intermediate-acting human insulin (NPH) in a basal-only regimen.

Methods: Demographic and socio-economic patient characteristics, hospital utilisation data, primary care visits, specialist physician visits and prescription data were extracted from registers covering the Danish population. Patients receiving basal insulin were identified during a 1-year inclusion period (2005) and allocated to a LAIA (n=303) or NPH group (n=8523).

Glycemic control and long-acting insulin analog utilization in patients with type 2 diabetes.

Introduction: The objective was to compare glycemic control, insulin utilization, and body weight in patients with type 2 diabetes (T2D) initiated on insulin detemir (IDet) or insulin glargine (IGlar) in a real-life setting in the Netherlands.

Methods: Insulin-naïve patients with T2D, starting treatment with IDet or IGlar between January 1, 2004 and June 30, 2008, were selected from the PHARMO data network. Glycemic control (hemoglobin A1c [HbA1c]), target rates (HbA1c <7%), daily insulin dose, and weight gain were analyzed comparing IDet and IGlar for patients with available HbA1c levels both at baseline and at 1-year follow-up.

The cost-effectiveness of somatropin treatment for short children born small for gestational age (SGA) and children with growth hormone deficiency (GHD) in Sweden.

Objective: Reduction in health-related quality of life is common in children born small for gestational age (SGA) or children with growth hormone deficiency (GHD). Growth hormone treatment with somatropin in these children leads to normalisation of height. The aim of this study was to determine whether somatropin is a cost-effective treatment option for short children born SGA and GHD children in Sweden.

Examining and interpreting responsiveness of the Diabetes Medication Satisfaction measure.

Objective: Treatment satisfaction (TS) is an important patient reported outcome (PRO) in diabetes as it is correlated with outcomes necessary for optimal treatment (e.g., compliance, self-management behaviour).

Qualitative research and content validity: developing best practices based on science and experience.

Purpose: Establishing content validity for both new and existing patient-reported outcome (PRO) measures is central to a scientifically sound instrument development process. Methodological and logistical issues present a challenge in regard to determining the best practices for establishing content validity.

Methods: This paper provides an overview of the current state of knowledge regarding qualitative research to establish content validity based on the scientific methodological literature and authors' experience.

Understanding and assessing the impact of treatment in diabetes: the Treatment-Related Impact Measures for Diabetes and Devices (TRIM-Diabetes and TRIM-Diabetes Device).

Purpose: Diabetes is a debilitating illness requiring lifelong management. Treatments can be varied in terms of mode of administration as well as type of agent. Unfortunately, most patient reported outcome measures currently available to assess the impact of treatment are specific to diabetes type, treatment modality or delivery systems and are designed to be either a HRQoL or treatment satisfaction measure.

Psychological insulin resistance: patient beliefs and implications for diabetes management.

Purpose: To define and understand patient psychological insulin resistance (PIR) and its impact on diabetes management.

Methods: Systematic literature review of peer-refereed journals using the MEDLINE database, including all articles in English from 1985 to 2007. The population included patients with type 1 and type 2 diabetes, insulin naïve, and those currently using insulin.

Utility values for symptomatic non-severe hypoglycaemia elicited from persons with and without diabetes in Canada and the United Kingdom.

Objective: To elicit societal and patient utilities associated with diabetic symptomatic non-severe hypoglycaemia for three health states: 1) rare (quarterly), 2) intermittent (monthly), 3) and frequent (weekly) hypoglycaemia episodes.

Methods: Using validated health states, time trade-off utilities were elicited from 51 Canadian respondents with diabetes, and 79 respondents in Canada and 75 respondents in the United Kingdom (UK) without diabetes.

Results And Discussion: Each hypoglycaemic episode was associated with a reduction in utility and persons with diabetes consistently reported slightly higher utility values than respondents without diabetes.

A critical review of the literature on fear of hypoglycemia in diabetes: Implications for diabetes management and patient education.

Objective: In many individuals with diabetes, the unpleasant symptoms and negative consequences associated with hypoglycemia may result in significant anxiety or even a fear of hypoglycemia (FoH). This fear may have significant clinical implications for diabetes management. The aim of this review is to integrate existing research on FoH (its measurement, predictors, correlates, impact and treatment) and discuss its implications for diabetes management and patient education.

Maximizing the value of validation findings to better understand treatment satisfaction issues for diabetes.

Background: Variables associated with treatment satisfaction (TS) can be broadly categorized as precursors, ongoing treatment issues, and treatment outcomes. This study continues the validation process for the Insulin Treatment Satisfaction Questionnaire (ITSQ) while examining relationships between TS and these broader influences.

Methods: Data (N = 299) were collected in a RCT comparing safety and efficacy of inhaled vs.