Long-term effectiveness of the Diabetes Conversation Map™ Program on health outcomes: A case-control retrospective cohort study.

AIM: To evaluate the clinical and health behavioural outcomes of a large sample of participants from the Diabetes Conversation Map™ Program. DESIGN: A matched-case-control study that was performed on a retrospective cohort study. METHODS: Participants were 11,053 Clalit Health Services members with type 2 diabetes who enrolled in the Diabetes Conversation Map™ Program between January 2010 - April 2016. The matched-control group was formulated using sequential matching, by matching cases to controls at a ratio of 1:3, based on age, sex, and HbA1c level. The associations between the programme group and annual clinical and health behaviours were assessed between cases and controls at five time points using linear and Poisson regression analyses. RESULTS: The intervention group had significantly lower HbA1c, glucose, and low-density lipoprotein levels and more frequent glucose blood testing each year up to 36 month post-enrolment compared with the matched controls. Other outcomes were significantly different for shorter time periods, including higher high-density lipoprotein and lower triglyceride levels at 6- and 12-month follow-up and lower diastolic blood pressure and greater medication adherence at 6-month follow-up. CONCLUSIONS: Enrolment in the programme was associated with improved clinical and health behaviour outcomes for at least 6 months and most outcomes persisted for up to 36 months. IMPACT: This is the first study to evaluate the Diabetes Conversation Map™ Program with a large sample over long period of time. This nurse-led group intervention evaluation adds to the literature on health outcomes on the lives of patients with type 2 diabetes. STUDY REGISTRATION: This study was registered retrospectively to the Open Science Framework, the registration form can be found at: https://osf.io/63cse.

Effectiveness of Managing Diabetes During Ramadan Conversation Map intervention: A difference-in-differences (self-comparison) design.

BACKGROUND: Some individuals with diabetes fast during Ramadan despite medical concerns for risk of adverse outcomes. The Managing Diabetes During Ramadan Conversation Map is a self-management education group-based intervention for Muslim individuals with type 2 diabetes, specifically addressing diabetes management during Ramadan. OBJECTIVE: The aim of this study was to evaluate the effectiveness of the Managing Diabetes During Ramadan Conversation Map intervention in improving short-term clinical outcomes and reducing healthcare utilization following Ramadan. DESIGN: This was a retrospective rolling cohort study. SETTINGS: Participants were Clalit Health Services members with type 2 diabetes who participated in the intervention between 2014 and 2017 across Israel. PARTICIPANTS: This study included 1732 participants who enrolled in the intervention over the five-year study period. The cohort was mainly between the ages of 45 and 74 years (83.3%), female (71.9%), of lower socioeconomic status (92.1%), with a diabetes duration of 10 years or more (51.7%), obese (64.0%), and had never smoked (73.8%). METHODS: The data used in this study came from Clalit Health Services' electronic health records, which are integrated in a central data warehouse. We used a difference-in-differences (self-comparison) design to examine the effect of the intervention on changes in laboratory results and healthcare utilization over a six month baseline and follow-up. Mixed model linear regressions and Poisson regressions were used to estimate continuous and count outcomes, respectively. RESULTS: Post intervention, participants experienced a reduction of 8.61 mg/dL in their glucose levels (p = 0.005) and 0.34% in their HbA1c levels (p < 0.001). In a sub-group analysis of participants with HbA1c > 7%, larger reductions in glucose (17.02 mg/dL [p < 0.001]) and HbA1c (0.63% [p < 0.001]) levels were recorded. This sub-group also experienced a reduction of 4.83 mg/dL in LDL level (p = 0.007) and had 0.2 fewer primary care visits (p < 0.001). CONCLUSIONS: Participation in the Managing Diabetes During Ramadan Conversation Map improved patient glucose and HbA1c levels. A greater benefit was reported in those individuals with HbA1c > 7%. These findings hold important global health implications for the millions of individuals with type 2 diabetes for whom Ramadan can pose a challenge in disease control.

Temporal changes in the incidence and predictors of severe hypoglycaemia in type 2 diabetes: The Fremantle Diabetes Study.

AIM: To determine the incidence of severe hypoglycaemia and its predictors in community-based patients with type 2 diabetes studied between 2008 and 2013 compared with those in a cohort of patients with type 2 diabetes from the same geographical area assessed a decade earlier. METHODS: We studied 1551 participants (mean age 65.7 years, 51.9% men) with type 2 diabetes from the longitudinal observational Fremantle Diabetes Study Phase II (FDS2). Severe hypoglycaemia was ascertained as that requiring ambulance attendance, emergency department services and/or hospitalization. Cox proportional hazards modelling was used to determine predictors of a first episode of severe hypoglycaemia, and negative binomial regression was used to identify predictors of frequency. RESULTS: Sixty-three participants (4.1%) experienced 83 episodes, representing an incidence of 1.34/100 participant-years (95% confidence interval [CI] 1.08 to 1.67; vs 1.67/100 participant-years [95% CI 1.31-2.13] in the Fremantle Diabetes Study Phase I [FDS1]; P = 0.18). Those experiencing severe hypoglycaemia experienced one to four episodes in both cohorts. The independent predictors of incident severe hypoglycaemia in the FDS2 were: older age; higher educational attainment; alcohol consumption; current smoking; sulphonylurea/insulin treatment; prior severe hypoglycaemia; renal impairment; and plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP). The same variables except smoking were associated with frequency of severe hypoglycaemia. Most of these risk factors paralleled those in the FDS1, but current smoking and plasma NT-proBNP were novel. CONCLUSIONS: The incidence and frequency of severe hypoglycaemia did not change between the Fremantle Diabetes Study phases but novel risk factors, including plasma NT-proBNP, were observed in the FDS2.

A multinational observational study assessing insulin use: Understanding the determinants associated with progression of therapy.

AIMS: To describe global patterns of insulin treatment and to assess the impact of patient, provider, health system and economic influences on treatment decisions for patients with insulin-treated type 2 diabetes (T2D). METHODS: This prospective cohort study of insulin-treated patients with T2D was conducted across 18 countries categorized as high, upper-middle or lower-middle income regions. Information collected from patients included knowledge of diabetes, experiences and interactions with their healthcare provider. Physician information included specialty, practice size, availability of diabetes support services, volume of diabetes patients treated and time spent per patient. Physicians determined an individualized haemoglobin A1c (HbA1c) target for each patient by the start of the study. Changes in T2D therapies and HbA1c were recorded for 2 years. RESULTS: Complete treatment data were available for 2528 patients. Median age was 61 years and median duration of diabetes was 11.4 years. Changes to treatment regimen occurred in 90.0% of patients, but changes were less common in countries with a higher economic status (P < 0.001). Most treatment changes involved insulin, with changes in dose the most common. Overall predictors of change in insulin therapy included younger age, use of any insulin regimen other than basal only, higher mean baseline HbA1c and longer duration of T2D. HbA1c levels remained constant regardless of regional economic status. At baseline, 20.6% of patients were at their HbA1c target; at 2 years this was 26.8%. CONCLUSIONS: Among insulin-treated patients with T2D, treatment changes were common; however, only approximately one-fourth of individuals achieved their HbA1c target.

Which patients with Type 2 diabetes will have greater compliance to participation in the Diabetes Conversation Map™ program? A retrospective cohort study.

AIM: To investigate the characteristics of participants in the Diabetes Conversation Map™ (Map™) program who had higher vs. lower compliance to the program, to determine if program tailoring and monitoring is needed among these groups. METHODS: This was a retrospective cohort study of 8990 patients enrolled in the Map™ program (low compliance [attending 0-1 sessions, n = 2759] and high compliance [attending ≥2 sessions, n = 6231]). Socio-demographic, clinical, health behaviors, and healthcare utilization characteristics were extracted. Multivariable stepwise logistic regression was used as the analysis strategy. RESULTS: Those who were of higher socio-economic status (OR = 1.567, 95%CI:1.317-1.865), who lived in urban area (OR = 1.501, 95%CI:1.254-1.798), with greater frequency of primary care visits (OR = 1.012, 95%CI:1.002-1.021), with medium (OR = 1.176, 95%CI:1.013-1.365) or high oral medication adherence (OR = 1.198, 95%CI:1.059-1.356), and with a greater frequency of blood glucose tests (OR = 1.102, 95%CI:1.033-1.175) had greater odds of being in the high compliance group. Conversely, those aged 35-44 (OR = 0.538, 95%CI:0.402-0.721) and 45-54 years (OR = 0.763, 95%CI:0.622-0.937), with longer Type 2 diabetes duration (OR = 0.980, 95%CI:0.967-0.993), with higher blood glucose levels (OR = 0.999, 95%CI:0.998-1.000), and current (OR = 0.659, 95%CI:0.569-0.762) or former smokers (OR = 0.831, 95%CI:0.737-0.938) had reduced odds for being in the higher compliance group. CONCLUSIONS: Instructors in advance can target sub-groups to increase their attendance rates, and consequently improve their outcomes.

The relationship between intensification of blood glucose-lowering therapies, health status and quality of life in type 2 diabetes: The Fremantle Diabetes Study Phase II.

AIMS: To determine whether therapeutic intensification in type 2 diabetes influences health status and quality of life (QoL). METHODS: We studied 930 participants in the longitudinal observational Fremantle Diabetes Study Phase II (mean age 65.3 years, 53.8% males, median diabetes duration 8.0 years) with valid data from baseline assessment and two biennial reviews (4 years of follow-up) between 2008 and 2015. The main outcome measures were the Short Form-12 version 2 physical and mental health composite scores (PCS, MCS) and the average weighted impact (AWI) score from the Audit of Diabetes Dependent QoL. RESULTS: There were reductions in PCS at Year 4 compared with baseline and Year 2 in patients on stable diet-based management (n = 160), oral glucose-lowering medication (OGLM; n = 387), and insulin with/without OGLM (n = 168; P < 0.05), but no statistically significant temporal changes in MCS/AWI. Insulin-treated patients had the lowest PCS, MCS and AWI compared to the other two subgroups at each time-point (P ≤ 0.012). In participants initiating OGLM (n = 84) or insulin (n = 85), there were no differences in PCS, MCS or AWI at the biennial assessments either side of these therapeutic changes (P ≥ 0.08). CONCLUSIONS: These real-life data show that treatment intensification, including insulin initiation, does not impact adversely on patient well-being in community-based type 2 diabetes. Since insulin use at entry was associated with longer diabetes duration, worse glycaemic control, and a greater risk of chronic complications, the burden of disease rather than treatment modality appears the primary determinant of health status and QoL.

Temporal changes in glycaemic thresholds for treatment intensification in type 2 diabetes in an urban Australian setting: the Fremantle Diabetes Study.

BACKGROUND: Pharmacotherapy and supportive care for diabetes in Australia are improving, with potential beneficial effects on therapeutic procrastination. AIM: To determine whether glycaemic thresholds for therapeutic intensification in type 2 diabetes changed over the 15 years between phases of the community-based Fremantle Diabetes Study (FDS). METHODS: We studied 531 Phase 1 participants (mean age 62.4 years, 54.2% males, median diabetes duration 3.0 years) with valid data from baseline assessment and five subsequent annual reviews between 1993 and 2001 and 930 Phase 2 participants (mean age 65.3 years, 53.8% males, median diabetes duration 8.0 years) with valid data from baseline and two subsequent biennial reviews between 2008 and 2015. The main outcome measure was HbA1c at assessments before and after change in blood glucose-lowering therapy (average 6 months in Phase 1, 12 months in Phase 2). RESULTS: Ninety-seven participants in Phase 1 and 84 in Phase 2 progressed from diet-based management to oral hypoglycaemic agents (OHA) and 45 and 85 participants, respectively, progressed from diet/OHA to insulin. The median HbA1c was 7.5% (58 mmol/mol) and 6.9% (52 mmol/mol) before OHA initiation in Phases 1 and 2, respectively, and 9.1% (76 mmol/mol) and 7.8% (62 mmol/mol), respectively, before insulin initiation. There were median HbA1c falls of 0.3% (3 mmol/mol) and 1.5% (16 mmol/mol) after OHA and insulin initiation in Phase 1, but no statistically significant changes in Phase 2. CONCLUSIONS: HbA1c thresholds triggering treatment intensification fell between FDS phases, suggesting a more proactive approach to management of glycaemia over time.

Does Trainee Involvement in Fluoroscopic Injections Affect Fluoroscopic Time, Immediate Pain Reduction, and Complication Rate?

BACKGROUND: Patients have expressed concern about undergoing procedures involving trainees, even with direct attending physician supervision. Little literature has examined the effect of trainee involvement on patient outcomes. OBJECTIVE: We aimed to evaluate the effect of trainee involvement on patient complications, immediate pain reduction, and fluoroscopic time for different fluoroscopic injection types. DESIGN: Retrospective review. SETTING: Four academic outpatient institutions with Accreditation Council for Graduate Medical Education (ACGME)-accredited residency (physical medicine and rehabilitation, or anesthesiology) or fellowship (sports medicine or pain medicine) programs from 2000 to 2015. PATIENTS: All patients receiving fluoroscopically guided hip (HI), sacroiliac joint (SIJI), transforaminal epidural (TFEI), and/or interlaminar epidural injections (ILEI, performed at only 1 institution). METHODS: Outcome measures were examined based on the presence or absence of a trainee during the procedure. MAIN OUTCOME MEASUREMENTS: The primary outcome was the number of immediate complications, with secondary outcomes being fluoroscopic time per injection (FTPI) and immediate numeric rating scale percentage improvement. RESULTS: Trainees were involved in 67.0% of all injections (N = 7,833). Complication rates or improvements in numeric rating scale scores showed no significant differences with trainee involvement for any injection type (P > .05). Trainee involvement was associated with increased FTPI for ILEIs (18.2 ± 10.1 seconds with trainees versus 15.1 ± 8.5 seconds without trainees, P < .001), but not for HIs (P = .60) or SIJIs (P = .51). Trainee involvement with TFEIs was dependent on institution for outcome with respect to FTPI (P < .001), with 28.1 ± 17.9 seconds with trainees and 32.1 ± 22.1 seconds without trainees (P = 0.51). CONCLUSIONS: This large multicenter study of academic institutions demonstrates that trainee involvement in fluoroscopically guided injections does not affect immediate patient complications or pain improvement. Trainee involvement does not increase fluoroscopic time for most injections, although there is an institutional difference seen. This study supports the notion that appropriate trainee supervision likely does not compromise patient safety for fluoroscopically guided injections. LEVEL OF EVIDENCE: II.

Exploring the role of the patient-physician relationship on insulin adherence and clinical outcomes in type 2 diabetes: Insights from the MOSAIc study.

BACKGROUND: The 2-year prospective MOSAIc (Multinational Observational Study assessing Insulin use: understanding the challenges associated with progression of therapy) study is investigating whether patient-, physician-, and health system-related factors affect outcomes in patients with type 2 diabetes (T2D). This baseline subanalysis investigated how aspects of the patient-physician relationship are associated with diabetes-related distress, insulin adherence, and glycemic control. METHODS: Patients with T2D taking insulin for ≥3 months were recruited at primary care and specialty practice sites in 18 countries. Physicians provided usual care. Clinical history and most recent HbA1c values were collected; patients were surveyed regarding their perception of physician interactions, diabetes-related distress level, and insulin adherence. RESULTS: The analysis population comprised 4341 patients. Four (of six) domains showed a significant relationship with total diabetes-related distress (P < 0.01). Poor insulin adherence was associated with greater diabetes-related distress (adjusted odds ratio [aOR] 1.14; 95% confidence interval [CI] 1.06-1.22), higher Discrimination (aOR 1.13; 95% CI 1.02-1.27) and Hurried Communication (aOR 1.35; 95% CI 1.20-1.53) scores, and a lower Explained Results score (aOR 0.86; 95% CI 0.77-0.97). Poor insulin adherence was associated with a 0.43% increase in HbA1c, whereas a 1-unit increase in total diabetes-related distress and Hurried Communication scores was associated with a 0.171% and 0.145% increase in HbA1c, respectively. CONCLUSIONS: Patients distressed about living with T2D, and dissatisfied with aspects of their interactions with physicians, exhibited poor insulin adherence. Perceived physician inattention and lack of engagement (and diabetes-related distress) directly affect insulin adherence and glycemic control.

Using Individual Experiences With Experimental Medications to Predict Medication-Taking Behavior Postauthorization: A DIA Study Endpoints Workstream.

From humanistic, clinical, and economic perspectives, it is important to understand patients' health care attitudes and behavior. Of particular interest in defining the value of a pharmacologic therapy is medication adherence. A DIA workstream was convened to define medication adherence in a drug-development context, explore the relevance of medication nonadherence from various stakeholder perspectives, examine methods of collecting medication adherence data in, or alongside, drug-development programs, and propose a robust approach to predicting medication adherence in routine clinical practice from data derived in, or alongside, drug-development programs. This article summarizes the workstream findings and guidance as it pertains to these objectives. The proposed approach to predicting medication adherence involves a patient-reported outcome (PRO) questionnaire that contains a series of standardized questions for patient self-completion that asks about likelihood of medication adherence in clinical practice, and that queries about perceived benefits and barriers to adherence on exit from an efficacy trial. This methodology can be used to both gain a better understanding of the experimental medication and compare the experimental treatment to comparator therapy as warranted. This approach may assist regulators and payers in making meaningful treatment comparisons and facilitate manufacturers in developing empirically based patient-support programs. This workstream will now turn to the challenge of developing the PRO questionnaire in line with this proposal.

Basal-bolus Therapy in Patients with Type 2 Diabetes Mellitus in the UK: Patient Characteristics, Treatment Patterns and the Effect of Switching to Premixed Insulin.

INTRODUCTION: Increasing emphasis is being placed on insulin use among patients with type 2 diabetes mellitus (T2DM). Basal-bolus (BB) therapy is regarded as the gold standard, but a high frequency of injections and the general complexity of this therapy are seen as barriers in real-world practice. Here we describe the characteristics and treatment patterns of patients with T2DM receiving BB in the UK, with specific focus on those switching to a simplified regimen of premixed insulin. METHODS: Patients with T2DM receiving BB from 1 January 2005 were identified from the Clinical Practice Research Datalink. Characteristics were described at treatment initiation or on 1 January 2005, and treatment patterns were assessed at 12 months of follow-up. Clinical factors were compared in two groups of patients who while receiving BB had one haemoglobin A1c (HbA1c) measurement of ≥53 mmol/mol (7.0%) and remained either on BB or switched to a premixed insulin regimen. RESULTS: Study criteria were met by 12,060 subjects (mean age 59 years; duration diabetes 12.4 years). The mean HbA1c concentration was 76 mmol/mol (9.1% of patients), and 84.0% of patients were overweight. At 12 months of follow-up, 74.5% of the patients who had started BB remained on it. While on BB, 8835 patients had a HbA1c measurement of ≥53 mmol/mol (7.0% of all patients); of these, 95.9% remained on BB and 4.1% switched to premixed insulin. Mean HbA1c levels were consistently higher for patients who switched to premixed insulin than for those who remained on BB, but the levels remained relatively unchanged over time. CONCLUSION: A large proportion of patients receiving insulin did not achieve good glycaemic control in clinical practice. A small subset with higher comorbidities and HbA1c levels switched to a simplified regimen. Little evidence was found that type of insulin therapy was associated with meaningful changes in key clinical factors over time. FUNDING: Eli Lilly and company.

THE CARIES MANAGEMENT SYSTEM: UPDATING COST-EFFECTIVENESS WITH 4-YEAR POSTTRIAL DATA.

OBJECTIVES: Long-term follow-up of the Caries Management System (CMS) protocol demonstrated that regular monitoring and noninvasive management of dental caries is effective in reducing the number of caries-related events over a 7-year period. This analysis complements the authors' original economic evaluation of the CMS by re-evaluating the per-protocol cost-effectiveness of the CMS approach. METHODS: An individual patient-simulation Markov model was developed previously, based on 3-year randomized-controlled trial (RCT) data, to simulate the incidence and progression of dental caries, and resultant interventions, and to evaluate the lifetime cost-effectiveness of the CMS versus standard dental care from the Australian private dental practitioner perspective (in which the baseline age distribution was similar to that of the Australian population). The 4-year posttrial follow-up data are used to re-evaluate the long-term cost-effectiveness of the CMS in a more real-life setting. RESULTS: The reduction in caries risk was maintained among those practices within which the CMS protocols were adhered to. The per-protocol model appears to be reasonably accurate at predicting the risk of restorative events in the posttrial follow-up period. The per-protocol lifetime cost per restorative event avoided is AUD1,980 (USD1,409; 1 AUD = 0.71 USD). CONCLUSIONS: The current analysis confirms that the CMS approach is both effective, when the protocols are adhered to appropriately, and cost-effective compared with standard care in the Australian private practice setting.

The effect of body mass index on fluoroscopic time and radiation dose during lumbar transforaminal epidural steroid injections.

OBJECTIVE: Transforaminal epidural steroid injections (TFESIs) are a commonly used, effective treatment for radicular pain. Accurate delivery of the injected medication helps to ensure maximum therapeutic efficacy and to decrease possible adverse events, and fluoroscopy is the preferred and most common image-guidance modality used to ensure accurate needle placement during lumbar TFESIs. However, fluoroscopic-guided lumbar TFESIs put patients at risk because of radiation exposure. The purpose of this study was to determine the relationship between body mass index (BMI) and fluoroscopy time and radiation dose during lumbar TFESIs. DESIGN: A retrospective study design was used. SETTING: The study was conducted at an academic orthopedic center. All procedures were performed by physicians board-certified in Physical Medicine and Rehabilitation (PM&R) and with subspecialty certification in sports medicine, or by a trainee under close supervision from an attending physician. PARTICIPANTS: Participants were patients who underwent fluoroscopic-guided lumbar TFESIs between February 2013 and March 2015 with a documented height/weight, fluoroscopy time, and radiation dose. INTERVENTIONS: All patients received unilateral or bilateral lumbar TFESIs with fluoroscopic guidance. Fluoroscopy time and dose were recorded. MAIN OUTCOME MEASURES: The main outcome measures were fluoroscopy time and radiation dose. A Bonferroni correction was implemented for multiple comparisons, defining statistical significance at p<.01. RESULTS: A total of 2,443 injections were performed on 1,548 patients. There were 419 normal, 572 overweight, and 557 obese patients, respectively. There were 1,426 first-time injections and 1,017 repeat injections. Sixty-nine percent (1,681) were unilateral injections, and 26.4% (645) were single level injections. A trainee was involved in 1,361 (55.7%) of the injections performed. The mean fluoroscopy time for all injections was 30.0±17.5 seconds, and the mean radiation dose was 2,164±1,484 mGy-cm(2). The mean fluoroscopy time was 27.7±15.2 seconds for normal weight patients, 30.0±21.0 seconds for overweight patients, and 32.2±15.1 seconds for obese patients, showing a significant difference between groups (p<.001). The mean radiation doses for each group were 1,376±450, 1,911±653, and 3,029±640 mGy-cm(2), respectively, with a significant increase in radiation dose with increasing BMI (p<.001). CONCLUSIONS: The findings of this study demonstrate that fluoroscopy radiation dose and fluoroscopy time during lumbar TFESIs are increased in patients with an elevated BMI, and in patients of greater age, but the presence of a trainee had no effect on fluoroscopy time.

Evaluation of a patient self-directed mealtime insulin titration algorithm: a US payer perspective.

Objective To model the potential economic impact of implementing the AUTONOMY once daily (Q1D) patient self-titration mealtime insulin dosing algorithm vs standard of care (SOC) among a population of patients with Type 2 diabetes living in the US. Methods Three validated models were used in this analysis: The Treatment Transitions Model (TTM) was used to generate the primary results, while both the Archimedes (AM) and IMS Core Diabetes Models (IMS) were used to test the veracity of the primary results produced by TTM. Models used data from a 'real world' representative sample of patients (2012 US National Health and Nutrition Examination Survey) that matched the characteristics of US patients enrolled in the randomized controlled trial 'AUTONOMY' cohort. The base-case time horizon was 10 years. Results The modeling results from TTM demonstrated that total costs in the base-case were reduced by $1732, with savings predicted to occur as early as year 1. Results from the three models were consistent, showing a reduction in total costs for all sensitivity analyses. Limitations Data from short-term clinical trials were used to develop long-term projections. The nature of such extrapolation leads to increased uncertainty. Conclusion The results from all three models indicate that the AUTONOMY Q1D algorithm has the potential to abate total costs as early as the first year.

A qualitative examination of the content validity of the EQ-5D-5L in patients with type 2 diabetes.

BACKGROUND: The EQ-5D is frequently used to derive utilities for patients with type 2 diabetes (T2D). Despite widely available quantitative psychometric data on the EQ-5D, little is known about content validity in this population. Thus, the purpose of this qualitative study was to examine content validity of the EQ-5D in patients with T2D. METHODS: Patients with T2D in the UK completed concept elicitation interviews, followed by administration of the EQ-5D-5L and cognitive interviewing focused on the instrument's relevance, clarity, and comprehensiveness. RESULTS: A total of 25 participants completed interviews (52.0 % male; mean age = 53.5 years). Approximately half (52 %) reported that the EQ-5D-5L was relevant to their experience with T2D. When asked if each individual item was relevant to their experience with T2D, responses varied widely (24.0 % said the self-care item was relevant; 68.0 % said the anxiety/depression item was relevant). Participants frequently said items were not relevant to themselves, but could be relevant to patients with more severe diabetes. Most participants (92.0 %) reported that T2D and/or its treatment/monitoring requirements had an impact on their quality of life that was not captured by the EQ-5D-5L. Common missing concepts included food awareness/restriction (n = 13, 52.0 %); activities (n = 11, 44.0 %); emotional functioning other than depression/anxiety (n = 8, 32.0 %); and social/relationship functioning (n = 8, 32.0 %). CONCLUSIONS: The results highlight strengths and potential limitations of the EQ-5D-5L, including missing content that could be important for some patients with T2D. Suggestions for addressing limitations are provided.

Insulin dosing and outcomes among commercially insured patients with type 2 diabetes in the United States.

PURPOSE: The purpose of this study was to examine costs, resource use, adherence, and hypoglycemic events among patients with type 2 diabetes mellitus (T2DM) treated with increasing doses of 100-U/mL (U-100) insulin regimens. METHODS: Data from Truven's Health Analytics Commercial Claims and Encounters database from January 1, 2008, through January 31, 2011, were used. Regressions were used to examine the associations among costs, resource use, adherence, and receipt of a hypoglycemic event and index dose of insulin. Specifically, general linear models with a γ-distribution and log link were used to examine costs, whereas logistic and negative binomial regressions were used to examine resource use and hypoglycemic events. All analyses controlled for patient characteristics, preindex comorbidities, general health, use of antidiabetic medications, and visits to an endocrinologist. FINDINGS: The study focused on 101,728 individuals with T2DM who received an outpatient prescription for U-100 insulin. In general, costs and resource use are highest among patients treated with the highest dose of insulin (>300 U/d). For example, all-cause and diabetes-related hospitalizations and office visits were highest in the highest-dose cohort. Costs generally followed the same pattern. Patients who were prescribed the lowest dose of insulin (10-100 U/d) generally had higher all-cause or diabetes-related inpatient and emergency department costs and resource use compared with those patients with an index dose >100 to 150, >150 to 200, and >200 to 300 U/d. There were generally no significant differences in rates of hypoglycemic events based on index dose. IMPLICATIONS: These results suggest significant differences in patient outcomes based on dosing of insulin. Those patients with T2DM using insulin at the highest and lowest dose ranges have the highest costs and resource use.

Geographic patterns in patient demographics and insulin use in 18 countries, a global perspective from the multinational observational study assessing insulin use: understanding the challenges associated with progression of therapy (MOSAIc).

BACKGROUND: Among patients with type 2 diabetes, insulin intensification to achieve glycemic targets occurs less often than clinically indicated. Barriers to intensification are not well understood. We present patients' baseline characteristics from MOSAIc, a study investigating patient-, physician-, and healthcare environment-based factors affecting insulin intensification and subsequent health outcomes. METHODS: MOSAIc is a longitudinal, observational study following patients' diabetes care in 18 countries: United Arab Emirates (UAE), Argentina, Brazil, Canada, China, Germany, India, Israel, Italy, Japan, Mexico, Russia, Saudi Arabia, South Korea, Spain, Turkey, United Kingdom, United States. Eligible patients are age ≥ 18, have type 2 diabetes, and have used insulin for ≥ 3 months with/without other antidiabetic medications. Extensive baseline demographic, clinical, and psychosocial data are collected at baseline and regular intervals during the 24-month follow-up. We conducted descriptive analyses of baseline data. RESULTS: Four thousand three hundred forty one patients met eligibility criteria. Patients received their type 2 diabetes diagnosis 12 ± 8 years prior to baseline visit, yet patients in developing countries were younger than in developed countries (e.g., UAE, 55 ± 10; Germany = 70 ± 10). Saudi Arabians had the highest HbA1c values (9.0 ± 2.2) and Germany (7.5 ± 1.4) among the lowest. Most patients in 5 (28%) of the 18 countries did not use an oral antidiabetic drug. Over half of patients in fourteen (78 %) countries exclusively used basal insulin; most Indian and Chinese patients exclusively used mixed insulin. CONCLUSIONS: MOSAIc's baseline data highlight differences in patient characteristics across countries. These patterns, along with physician and healthcare environment differences, may contribute to the likelihood of insulin intensification and subsequent clinical outcomes.

Dosing of U-100 insulin and associated outcomes among Medicare enrollees with type 1 or type 2 diabetes.

OBJECTIVE: To examine costs, resource utilization, adherence, and hypoglycemic events among various doses of U-100 insulin regimens among elderly patients (age ≥65 years) diagnosed with diabetes. METHODS: Truven Health Analytics Medicare databases from January 1, 2008 through December 31, 2011 were utilized. General linear models with a gamma distribution and log link were used to examine costs, while logistic and negative binomial regressions were used to examine resource utilization and hypoglycemic events. Analyses controlled for patient characteristics, pre-period comorbidities, general health, and use of antidiabetic medications as well as index dose of insulin. RESULTS: All-cause inpatient, emergency room, and outpatients costs, as well as diabetes-related inpatient costs, were highest among individuals who were treated with an index dose of 10-100 units/day followed by >300 units/day, while drug costs and total costs generally increased as index dosage increased. Resource utilization generally followed the same pattern as costs, with number of office visits increasing as the dose increased and the highest hospital length of stay, number of hospitalizations, number of emergency room visits, and number of diabetes-related hospitalizations were generally highest among those in the lowest and highest index dose cohorts. Compared to patients who initiated with an index dose of 10-100 units/day, all other patients were significantly less likely to achieve an adherence threshold of 80% based upon index dose range, and while those with an index dose of >100-150 units/day were significantly more likely to experience a hypoglycemic event. CONCLUSION: These results suggest that, for elderly individuals with diabetes, there is a higher patient burden among those who receive the lowest and highest insulin doses.

Early Glycemic Response Predicts Achievement of Subsequent Treatment Targets in the Treatment of Type 2 Diabetes: A Post hoc Analysis.

INTRODUCTION: American Diabetes Association consensus guidelines emphasize individualized treatment in the management of type 2 diabetes mellitus (T2DM). Early glycemic response is a clinical marker that may predict longer term efficacy for individual patients and provide a clinical tool to enhance personalized treatment. This analysis evaluated whether glycemic response measured at week 12 ("early") could serve as a reliable predictor of glycemic control at weeks 24 and 52 of therapy in patients with T2DM. METHODS: We used data from 3 randomized, controlled clinical trials that evaluated patients with T2DM treated with 3 commonly prescribed glucose-lowering medications: metformin (n = 597), sulfonylurea (n = 626), and insulin glargine (n = 1046). The gradient boosting method was used to identify predictors of subsequent response; predictive accuracy was represented by sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Treatment success at weeks 24 and 52 was assessed for each patient and defined as achieving a glycated hemoglobin (HbA1c) level of <7.0% or a reduction from baseline of ≥1.0%. RESULTS: The predictive parameters (sensitivity, specificity, PPV, and NPV) for improvements in HbA1c at week 24 for metformin were 0.83, 0.81, 0.44, and 0.96; for sulfonylurea, 0.79, 0.94, 0.71, and 0.96; and for insulin glargine, 0.67, 0.89, 0.65, and 0.90. The predictive parameters for improvements in HbA1c at week 52 for metformin were 0.73, 0.84, 0.56, and 0.92 and for sulfonylurea, 0.45, 0.94, 0.74, and 0.82. CONCLUSION: High predictive values identified in this analysis support "early" response as an appropriate tool for predicting treatment success at weeks 24 and 52. The high NPV (lack of early glycemic response) appears to be an effective indicator of the likely need for change in (or intensification of) therapy. These data support the current guideline recommendations that clinicians evaluate therapeutic responses to pharmacologic interventions with metformin, sulfonylureas, or insulin glargine as early as week 12.