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Sotagliflozin, a dual sodium-glucose co-transporter (SGLT)1/SGLT2 inhibitor, is currently approved in Europe as an adjunct to optimal insulin therapy in adults with type 1 diabetes (T1D) and a body mass index (BMI) ≥ 27 kg/m2 . In this post hoc analysis, efficacy at 24 weeks and safety at 52 weeks from pooled phase 3 clinical trials were evaluated in patients with baseline BMI ≥ 27 kg/m2 . Sotagliflozin 200 mg and 400 mg added to insulin reduced glycated haemoglobin level and increased time in range assessed by continuous glucose monitoring versus placebo and also reduced body weight and systolic blood pressure. Differences in efficacy endpoints between sotagliflozin and placebo tended to be greater among patients with BMI ≥ 27 kg/m2 compared to those with baseline BMI

Summary Background The DEPICT-1 and DEPICT-2 studies showed that dapagliflozin as an adjunct to insulin in individuals with inadequately controlled type 1 diabetes improved glycaemic control and bodyweight, without increase in risk of hypoglycaemia. We aimed to determine the effect of dapagliflozin on urinary albumin-to-creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR) using pooled data from the DEPICT studies. Methods In this post-hoc analysis, we used data pooled from both DEPICT studies (DEPICT-1 ran from Nov 11, 2014, to Aug 25, 2017; DEPICT-2 ran from July 8, 2015, to April 18, 2018), in which participants were aged 18–75 years, with inadequately controlled type 1 diabetes and with a baseline UACR of at least 30 mg/g. In the DEPICT studies, participants were randomly assigned (1:1:1) to receive dapagliflozin (5 mg or 10 mg) or placebo all plus insulin, for 24 weeks, with a 28-week long-term extension (ie, 52 weeks in total). In this post-hoc analysis, we assessed the percentage change from baseline in UACR and in eGFR, up to 52 weeks. UACR, eGFR, and safety were assessed in all eligible participants who had received at least one dose of study drug. HbA1c, bodyweight, and systolic blood pressure were assessed in all participants who received at least one dose of study drug during the first 24-week period, and who had a baseline and any post-baseline assessment for that parameter. The DEPICT trials were registered with ClinicalTrials.gov , NCT02268214 (DEPICT-1), NCT02460978 (DEPICT-2), and are now complete. Results 251 participants with albuminuria at baseline were included in this post-hoc analysis; of whom 80 (32%) had been randomly assigned to dapagliflozin 5 mg, 84 (33%) to dapagliflozin 10 mg, and 87 (35%) to placebo. Compared with placebo, treatment with both dapagliflozin doses improved UACR over 52 weeks. At week 52, mean difference in change from baseline versus placebo in UACR was −13·3% (95% CI −37·2 to 19·8) for dapagliflozin 5 mg and −31·1% (−49·9 to −5·2) for dapagliflozin 10 mg. No notable change from baseline was seen in eGFR, with a mean difference in change from baseline versus placebo of 3·27 mL/min per 1·73 m2 (95% CI −0·92 to 7·45) for dapagliflozin 5 mg and 2·12 mL/min per 1·73 m2 (–2·03 to 6·27) for dapagliflozin 10 mg. Similar proportions of participants in each treatment group had adverse events and serious adverse events, including hypoglycaemia and diabetic ketoacidosis; no new safety signals were identified in this population. Interpretation Treatment with dapagliflozin resulted in UACR reduction, which might provide renoprotective benefits in individuals with type 1 diabetes and albuminuria. Dedicated prospective studies are needed to confirm these findings as prespecified endpoints. Funding AstraZeneca.

Robert (Bob) Roy Henry was born 12 March 1950 in Winnipeg, Manitoba, Canada, to Ken and Paula (nee Baldwin) Henry. His father was a train engineer and his mother a homemaker from Kent, England. Bob was raised in Transcon, a small town outside the city where most people joined the railway to make a living, and that is what his future looked like also. Bob and his wife, Denine McBeth, first met as teenagers. She was 16 and a cheerleader from a rival high school; he was 17 and owned a motorcycle. Robert R. Henry, MD The year following high school graduation he was able to find work at Manitoba Steel as a laborer. It was this experience that convinced him to pursue his education at the University of Winnipeg. Bob had a natural thirst for knowledge and thrived in the academic environment. During the course of his studies, he was in line for an academic excellence award (Canada’s recognition of students with outstanding achievements). However, Bob knew it would require another year at the University of Winnipeg and his interests had changed. He decided against pursuing the academic distinction and instead applied to and was accepted at the University of Manitoba in the field of medicine in 1971, graduating in 1975. Left panel: Bob at 4 years old; right panel: Bob at graduation from the University of Manitoba, 1975 In 1973 he and Denine were married, and 2 years later their first son, Ryan, was born. During that time he was the president of the interns and residents’ association of Manitoba. After he graduated, he thought seriously of pursuing a specialty in cardiology at the University of Manitoba Health Science Centre. Unfortunately, on 11 September 1976, Bob, Denine, and Ryan were involved in a serious car accident that left …

Author(s): Pettus, Jeremy H; Zhou, Fang Liz; Shepherd, Leah; Mercaldi, Katie; Preblick, Ronald; Hunt, Phillip R; Paranjape, Sachin; Miller, Kellee M; Edelman, Steven V | Abstract: AimsTo use electronic health record data from real-world clinical practice to assess demographics, clinical characteristics and disease burden of adults with type 1 diabetes (T1D) in the United States.Materials and methodsRetrospective observational study of adults with T1D for ≥24 months at their first visit with a T1D diagnosis code ("index date") between July 2014 and June 2016 in the Optum Humedica database. Demographic characteristics, acute complications (severe hypoglycaemia [SH], diabetic ketoacidosis [DKA]), microvascular complications, cardiovascular (CV) events and health care resource utilization during the 12 months before the index date ("baseline period") were compared between patients with optimal versus suboptimal glycaemic control (glycated haemoglobin [HbA1c] l7.0% vs. ≥7.0% [53 mmol/mol]) at the closest measurement to the index date.ResultsOf 31 430 adults with T1D, 79.9% had suboptimal glycaemic control (mean HbA1c 8.8% [73 mmol/mol]). These patients were more likely to be younger, African American, uninsured or on Medicaid, obese, smokers, have uncontrolled hypertension and have depression. Despite worse glycaemic control and increased CV risk factors of uncontrolled hypertension, obesity and smoking, rates of coronary heart disease and stroke were not higher in these patients. Patients with suboptimal glycaemic control also experienced more diabetes complications (including SH, DKA and microvascular disease) and utilized more emergency care, with more emergency department visits and inpatient stays.ConclusionThis real-world study of g30 000 adults with T1D showed that individuals with suboptimal versus optimal glycaemic control differed significantly in terms of health care coverage, comorbidities, diabetes-related complications, health care utilization and CV risk factors. However, suboptimal control was not associated with increased risk of CV outcomes.

A patient who is overweight with type 2 diabetes and takes multiple oral antihyperglycemic agents has been informed that the current treatment plan is not providing adequate glycemic control and that adding insulin therapy is recommended. However, the patient is concerned about insulin causing weight gain or leading to hypoglycemia and is looking for a treatment that will avoid or reduce these issues. Taking all of these considerations into account, the health care provider recommends that the patient start insulin and a glucagon-like peptide 1 (GLP-1) receptor agonist given as fixed-ratio combination (FRC) therapy administered with a prefilled pen device that allows for both basal insulin and a GLP-1 receptor agonist to be delivered in a single daily injection. Basal insulin and GLP-1 receptor agonists have different but complementary modes of action. Basal insulin predominantly regulates blood glucose between widely spaced meals and overnight (1) through the movement of glucose from blood into certain cells of the body (including skeletal muscle) and the suppression of hepatic glucose production (2); GLP-1 receptor agonists affect glucose control through glucose-dependent insulin secretion, slowing gastric emptying, inducing satiety, and suppressing excess postprandial glucagon release (3). FRC therapies that contain both a basal insulin and a GLP-1 receptor agonist have been shown to improve glycemic control with a risk of hypoglycemia that is similar to that associated with the use of basal insulin alone (4,5). In addition, FRC therapies have been shown to mitigate insulin-induced weight gain and to reduce the likelihood of the gastrointestinal (GI) adverse events that are associated with the use of GLP-1 receptor agonists. This effect is the result of slower up-titration of the GLP-1 receptor agonist component of an FRC compared with the titration schedule recommended when a GLP-1 receptor agonist is used alone (6–8). …

Video abstract: View a video abstract for this article. AIMS This multicentre (N = 104), randomized controlled phase 4 study compared the efficacy and safety of insulin glargine 300 units/mL (Gla-300) with insulin glargine 100 units/mL (Gla-100) in patients with type 1 diabetes (T1D). MATERIALS AND METHODS Patients were randomized 1:1 to self-perform morning Gla-300 or Gla-100 injections daily for 16 weeks. The primary endpoint was percentage of time blood glucose remained in the target range (70-180 mg/dL) during Week 15/16, measured by blinded continuous glucose monitoring. Secondary endpoints included incidence and rate of nocturnal symptomatic hypoglycaemia (≤70 mg/dL), glycaemic variability parameters and safety assessments. Exploratory analyses were performed in patients with glycated haemoglobin (HbA1c)

Physician-patient communication when discussing the need for additional oral medication for type 2 diabetes (add-on) may affect the self-care of people with this condition. We aimed to investigate physicians' recalled experiences of the add-on consultation.We conducted a cross-sectional survey of physicians treating people with type 2 diabetes in 26 countries, as part of a large cross-national study of physician-patient communication during early treatment of type 2 diabetes (IntroDia®). The survey battery included novel questions about physician experiences at add-on and the Jefferson Scale of Physician Empathy.Of 9247 eligible physicians, 6753 responded (73.0% response rate). Most (82%) agreed that physician-patient discussions at add-on strongly influence patients' disease acceptance and treatment adherence. Half the physicians reported ≥1 challenge in most or all add-on conversations, with a significant inverse relationship between frequency of challenges and Jefferson Scale of Physician Empathy score (standardised β coefficient: -0.313; p 0.001). Physicians estimated that only around half their patients with type 2 diabetes follow their self-care advice. Exploratory factor analysis of physician beliefs about why their patients did not follow recommendations yielded two distinct dimensions: psychosocial barriers (e.g. depressed mood) and personal failings of the patient (e.g. not enough willpower) (r = 0.37, p 0.001).Physicians' empathy and beliefs about their patients may play a significant role in their success with the add-on conversation and, consequently, promotion of patient engagement and self-care. Although the study was limited by its retrospective, cross-sectional nature, the findings from IntroDia® may inform efforts to improve diabetes care.

Overconsumption of added sugars is a key contributor to the growing obesity, prediabetes, and type 2 diabetes pandemics. The nutrition therapy guidance of the American Diabetes Association recognizes that using low- and no-calorie sweeteners (LNCS) to reduce consumption of added sugars can reduce low–nutrient-density sources of calories and carbohydrate to beneficially affect glycemia, weight, and cardiometabolic health. This article provides information for primary care providers, diabetes care and education specialists, and other diabetes clinicians on the safety of LNCS and summarizes research evidence on the role of LNCS in glycemic and weight management. It also provides practical strategies for counseling individuals about how to integrate LNCS into their healthy eating pattern.

Background: A composite metric for the quality of glycemia from continuous glucose monitor (CGM) tracings could be useful for assisting with basic clinical interpretation of CGM data. Methods: We assembled a data set of 14-day CGM tracings from 225 insulin-treated adults with diabetes. Using a balanced incomplete block design, 330 clinicians who were highly experienced with CGM analysis and interpretation ranked the CGM tracings from best to worst quality of glycemia. We used principal component analysis and multiple regressions to develop a model to predict the clinician ranking based on seven standard metrics in an Ambulatory Glucose Profile: very low–glucose and low-glucose hypoglycemia; very high–glucose and high-glucose hyperglycemia; time in range; mean glucose; and coefficient of variation. Results: The analysis showed that clinician rankings depend on two components, one related to hypoglycemia that gives more weight to very low-glucose than to low-glucose and the other related to hyperglycemia that likewise gives greater weight to very high-glucose than to high-glucose. These two components should be calculated and displayed separately, but they can also be combined into a single Glycemia Risk Index (GRI) that corresponds closely to the clinician rankings of the overall quality of glycemia (r = 0.95). The GRI can be displayed graphically on a GRI Grid with the hypoglycemia component on the horizontal axis and the hyperglycemia component on the vertical axis. Diagonal lines divide the graph into five zones (quintiles) corresponding to the best (0th to 20th percentile) to worst (81st to 100th percentile) overall quality of glycemia. The GRI Grid enables users to track sequential changes within an individual over time and compare groups of individuals. Conclusion: The GRI is a single-number summary of the quality of glycemia. Its hypoglycemia and hyperglycemia components provide actionable scores and a graphical display (the GRI Grid) that can be used by clinicians and researchers to determine the glycemic effects of prescribed and investigational treatments.

Studies on acute complications in adult T1D were previously reported from the United States (U.S.) and from Germany. The aim was to compare demographic characteristics and patterns of severe hypoglycaemia (SH) and diabetic ketoacidosis (DKA) between Germany and the U.S.Descriptive comparison on individuals aged ≥18 years, with T1D duration ≥2 years were made between the German diabetes-patient registry (DPV) and the U.S. electronic-health-record database (T1PCO). Individuals in both databases were divided into patients with haemoglobin A1c (HbA1c)7% and HbA1c ≥7%.5190 (DPV) and 31,430 individuals (T1PCO) fulfilled the inclusion criteria. DPV patients were younger, more often male and had lower body-mass index. In both databases, more males than females had HbA1c7%. Individuals had higher HbA1c in T1PCO compared to DPV. The relationship between HbA1c and DKA was similar in both databases. SH revealed a U-shaped curve in T1PCO, but no clear pattern was present in DPV. SH events increased with higher age in DPV, but not in T1PCO.Patterns of SH differ between Germany and U.S. Differences in capture of SH among the databases cannot be excluded, but differences in health care including patient education and level of care by specialists are likely.

Many people with insulin-treated diabetes continue to experience inadequate glycemic control and a high incidence of hypoglycemic events, despite improvements in therapeutic strategies. While glycated hemoglobin (HbA

Use of continuous glucose monitoring (CGM) has been shown to improve glycemia control, reduce hypoglycemia, lower glycemic variability and enhance quality of life for individuals with type 1 diabetes and type 2 diabetes. However, many primary care physicians may be unfamiliar with the how CGM data can interpreted and acted upon. As adoption of this technology continues to grow, primary care physicians will be challenged to integrate CGM into their clinical practices. This article is intended to provide clinicians with practical guidance in interpreting and utilizing CGM data with their patients.

The study compares acute complications among adults with type 1 diabetes (T1D) by glycemic control in a U.S. Electronic Health Record database (T1PCO) with the German/Austrian Prospective Diabetes Follow-up (DPV). T1PCO included 31,430 and DPV 5,190 individuals in the analysis (age ≥18 years, T1D duration ≥2 years). During baseline (12 months prior to index date), ≥1 HbA1c and ≥1 insulin prescription was required. Baseline demographics, severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) were analyzed for overall populations, by age group, and glycemic control (HbA1c categories). In both databases, incidence of DKA was highest in those with HbA1c ≥9.0%. Additionally, the incidence of DKA (per year) increased with deteriorating control (HbA1c Disclosure F.L. Zhou: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. J. Hermann: None. J. Pettus: Consultant; Self; Diasome Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., MannKind Corporation, Novo Nordisk Inc., Sanofi. W. Kerner: None. K. Miller: None. L. Stechemesser: None. S. Edelman: Advisory Panel; Self; Brightsight, InPen, Lexicon Pharmaceuticals, Inc., Lilly Diabetes, Novo Nordisk A/S. Board Member; Self; Senseonics. Speaker’s Bureau; Self; AstraZeneca, MannKind Corporation, Merck & Co., Inc., Sanofi. A.M. Ibald-Mulli: Employee; Self; Sanofi-Aventis. R.W. Holl: None. Funding Sanofi

Glycemic control is suboptimal in many people with T1D. Diabetes technology may help improve diabetes management but data on its use in specific age groups and geographies is limited. SAGE was a multinational, cross-sectional study using data from medical records and interviews of eligible participants (N=3858) aged ≥26 years with T1D for ≥1 year. The use of diabetes technology in different regions (Asia, Eastern Europe, Western Europe [WE], Latin America and Middle East) by predefined age groups (26- Overall, finger stick blood glucose meters were used most frequently (92.0%), with similar proportions of participants using them across regions and age groups. Use of continuous glucose meters (CGM; 23.2%), insulin pumps (19.5%) and blood ketone meters (11.1%) varied between regions, while usage within each region varied somewhat between age groups (Table). Overall, use of an insulin dosing app was low (4.6%) and mostly when recommended by an HCP, with slightly more frequent use in those aged 26- Use of CGM, insulin pump and blood ketone meter is notably higher in WE than other regions. Globally, use of an insulin dosing app is low and appears to be mostly driven by HCP recommendations. Increased use of diabetes technology may help individuals and HCPs to manage diabetes better. Disclosure S. Edelman: Advisory Panel; Self; Brightsight, InPen, Lexicon Pharmaceuticals, Inc., Lilly Diabetes, Novo Nordisk A/S. Board Member; Self; Senseonics. Speaker’s Bureau; Self; AstraZeneca, MannKind Corporation, Merck & Co., Inc., Sanofi. D. Bruttomesso: Consultant; Self; Abbott, Eli Lilly and Company, Movi, Novo Nordisk, Roche Diagnostics, Sanofi. K.L. Close: Other Relationship; Self; Abbott, Air Liquide, American Diabetes Association, AstraZeneca, Dexcom, Inc., Janssen Pharmaceuticals, Inc., JDRF, Leona M. and Harry B. Helmsley Charitable Trust, Lilly Diabetes, Merck & Co., Inc. A.G. Vianna: Board Member; Self; Abbott, Medtronic, Novo Nordisk A/S. Research Support; Self; Sanofi. Speaker’s Bureau; Self; Lilly Diabetes. F. Lauand: Employee; Self; Sanofi. S. Brette: Other Relationship; Self; Sanofi. E. Renard: Board Member; Self; Abbott, Insulet Corporation, Novo Nordisk A/S, Roche Diabetes Care. Consultant; Self; Air Liquide, Eli Lilly and Company, Sanofi. Research Support; Self; Dexcom, Inc., Tandem Diabetes Care. Funding Sanofi

The gold-standard goal of diabetes management has been to achieve meaningful and sustained glycemic control to reduce the risk of long-term complications. Unfortunately, results from the National Health and Nutrition Examination Survey indicate that only ∼50% of adults with diabetes in the United States, mostly with type 2 diabetes, are achieving an A1C 9%, has actually increased (2,3). The Healthcare Effectiveness Data and Information Set results, with data from >1,000 health plans covering >171 million lives, are even more striking, demonstrating that, in 2014, ∼40% of commercially insured health maintenance organization patients and 30% of government insured patients achieved an A1C 40 new treatment options for people with type 2 diabetes. This fact is quite shocking and difficult to understand, especially given that our armamentarium of effective and safe type 2 medications has expanded over the same time period to include dipeptidyl peptidase 4 (DPP-4) inhibitors, sodium glucose cotransporter 2 inhibitors, designer insulins, inhaled insulin, and glucagon-like peptide 1 (GLP-1) receptor agonists. Although there may be many reasons why these new treatment options haven’t made a dent in the glycemic control of our patients with type 2 diabetes during these past 10 years, I feel strongly that the basic and primary issue is a lack of patient education, motivation, and activation. Type 2 diabetes is a silent condition with few or no symptoms caused by poor …

Objective: Pramlintide co-administration, used in conjunction with prandial insulin, has substantial clinical benefits to improve post-prandial glucose excursions, glycemic variability (GV) and time in range (TIR), but is associated with an increased injection burden that adversely affects adherence and persistence. A novel, fixed-ratio co-formulation of pramlintide and regular insulin (XP-3924) was evaluated in a phase 2 single injection study measuring XP-3924 pharmacokinetics (PK), glucose pharmacodynamics (PD), and its effects upon overall glycemic control. Methods: This was a Phase 2 randomized, open-label, active comparator-controlled, three-period cross-over study, which enrolled 18 adults with T1D to compare the PK and PD, glycemic affects and safety and tolerability of a single dose of XP-3924, to co-administration of regular insulin (Humulin® R) and pramlintide (Symlin®), and to an injection of regular insulin (RI) alone. Subjects were randomly allocated to a sequence of three treatments: XP-3924 (with 50% insulin reduction based their insulin to carbohydrate ratio), RI, or co-administration (RI with 50% insulin reduction plus a comparable pramlintide dose, co-administered as separate injections). The study drugs were administered subcutaneously 30 minutes before a 75-gram oral glucose challenge and glucose levels were monitored for 6 hours. Results: XP-3924 treatment resulted in a 62.3% reduction of hyperglycemia (blood glucose AUC0-3 hr >180 mg/dL) after the glucose challenge when compared to RI (p

Despite U.S. Food and Drug Administration (FDA) approval of over 40 new treatment options for type 2 diabetes since 2005, the latest data from the National Health and Nutrition Examination Survey show that the proportion of patients achieving glycated hemoglobin (HbA1c)

Introduction Previous research has found that the percentage of US adults with diabetes achieving a glycated hemoglobin (HbA1c) target of 9.0% increased from 12.6% (95% CI 10.5–14.8%) to 15.5% (95% CI 12.9–18.2%). Achievement of individualized targets varied by age group and presence of comorbidities, but exhibited similar trends as general target achievement. Conclusions Despite the development of many new medications to treat diabetes during the past decade, the proportion of patients achieving glycemic control targets has not improved. Funding Intarcia Therapeutics. Electronic supplementary material The online version of this article (doi:10.1007/s13300-017-0280-5) contains supplementary material, which is available to authorized users.

With the expiration of patent protection for several originator insulin analog molecules, the availability of insulin analog copies is set to increase. Many regulatory authorities have developed, and continue to refine, guidelines for the approval of biosimilar insulin analogs. Aspects such as the structure, pharmacokinetics and pharmacodynamics, efficacy, safety, and immunogenicity of biosimilar insulin analogs are extensively addressed in these guidelines, but how the biosimilar insulin analog is administered to people with diabetes is not usually a topic. The aim of this article is to highlight that the delivery device-drug combination is of particular importance. Regulatory, legal, and practical aspects of the delivery device, be it a syringe, pen, or pump, have to be considered in the context of biosimilar insulin analogs. Although the safety and efficacy of biosimilar insulin analogs per se are of primary importance for physicians and people with diabetes, functions and features of the devices used for administration also require attention from a practical point of view. Unfortunately, although there are several clinical studies investigating the technical aspects of and patient preference for the originator insulin analog pens, there are currently very little published data for nonoriginator or biosimilar insulin analog pens. In addition, it is not known if it is safe to assume that a biosimilar insulin analog cartridge is compatible with an existing originator insulin analog pen. We believe that there is a need for more discussion on the role of devices for administration of biosimilar insulin analogs.

While research designed to understand the concerns about hypoglycemia among patients with diabetes has been primarily focused on the investigation of fear and anxiety, recent evidence suggests a potentially important and conceptually distinct element-hypoglycemic confidence. To investigate this dimension, we developed the Hypoglycemic Confidence Scale (HCS); herein, we describe the construction and validation of the HCS and examine how key patient factors are associated with hypoglycemic confidence.Items were developed from interviews with six type 1 diabetes (T1D) adults, six insulin-using type 2 diabetes (T2D) adults, and seven diabetes healthcare professionals, resulting in nine self-report items. Separate exploratory factor analyses (EFAs) were conducted with T1D adults (N = 326), with T2D adults using both basal and prandial insulins (T2D-BP, N = 145) and with T2D adults using only basal insulin (T2D-BO, N = 82). Construct validity for the HCS was established with overall well-being (World Health Organization-5), diabetes distress (Diabetes Distress Scale), global anxiety (Generalized Anxiety Disorder), hypoglycemic fear (Hypoglycemic Fear Survey-II), and glycemic control (self-reported A1C). Hierarchical regression analyses examined the unique contribution of HCS scores, independent of hypoglycemic fear, on key psychosocial constructs and A1C.EFAs of the nine HCS items yielded a single factor solution for each of the three subject samples, accounting for 50.8%, 65.1%, and 73.7% of the variance for the T1D, T2D-BP, and T2D-BO groups, respectively. Construct validity was established by significant correlations with criterion variables. The HCS was associated with well-being and diabetes distress in the T1D (in both cases, P 0.001) and T2D-BP groups (in both cases, P .05) and for self-reported A1C in the T2D-BP group (P .05) independent of hypoglycemic fear.Hypoglycemic confidence is a unique dimension of patient experience, different from hypoglycemic fear, and is deserving of further study. The HCS is a reliable valid measure of hypoglycemic confidence for adults with T1D and insulin-using T2D.

Introduction The National Lipid Association Statin Intolerance (SI) Panel recognized the need for better understanding of the patient SI experience. Objective The objective of this research was to develop a patient-reported outcome (PRO) questionnaire to assess a patient’s experience with SI. Methods Questionnaire development was informed via a series of research activities: literature review, concept elicitation, item generation, and content evaluation. Following the literature review and concept elicitation, a draft questionnaire was constructed and subsequently modified based on feedback from therapeutic area experts and patients via cognitive debriefing interviews. Results Muscle-related symptoms were the most commonly reported symptoms associated with SI in the literature review (35 of 41 articles reviewed [85%]) and in semi-structured interviews with experts (n = 5 [100%]) and patients (n = 17 of 20 [85.0%]). Physical and other impacts of SI symptoms on daily activities were also frequently reported. A 17-item draft questionnaire was created, and cognitive debriefing with experts (n = 5) and patients (n = 15) was conducted. Overall, the items, response options, and instructions were comprehensible and positively reviewed; minor changes resulted in the 15-item Statin Experience Assessment Questionnaire (SEAQ)©. Using a 30-day recall period, the SEAQ© assesses the severity and impact of six SI symptoms (muscle ache, muscle pain, muscle cramps, muscle weakness, tiredness, and joint pain) on an 11-point numeric scale. Statin discontinuation and likelihood of discontinuation due to symptoms are assessed and scored on a yes/no and five-point verbal response scale, respectively. Conclusion The SEAQ© is a novel content-valid PRO questionnaire that assesses patient SI experience and fosters dialogue about SI between patients and providers. Electronic supplementary material The online version of this article (doi:10.1007/s40271-016-0211-y) contains supplementary material, which is available to authorized users.

Persistence with multiple daily insulin injections (MDI) may be challenging for patients with type 2 diabetes (T2DM). However, limited information is available regarding the effect of persistence with MDI on outcomes.To evaluate persistence with basal and bolus insulin therapy and assess its relationship with clinical and economic outcomes in a real-world setting.This retrospective matched cohort study used 2012-2015 data from multiple U.S. commercial health plans (IBM MarketScan). Patients with T2DM aged 18-64 years with ≥ 2 basal and ≥ 2 bolus insulin claims during a 12-month period were eligible for inclusion if they had 18 months of continuous health plan enrollment (6-month baseline and 12-month post-index). Persistence during 12 months post-index was defined using 2 methods: (a) method 1, ≤ 90-day gaps in both basal and bolus insulin claims and (b) method 2, ≥ 1 basal and ≥ 1 bolus insulin claim every quarter (every 90 days) for 4 consecutive quarters after index bolus claim. Propensity score matching was used to match persistent and nonpersistent method 2 cohorts. Mean per-patient all-cause and diabetes-related medical costs (2015 U.S. dollars, excluding outpatient drugs) and health care resource use (HCRU) were calculated. For patients with hemoglobin A1c (A1c) values during baseline and post-index months 10-12, treatment success was defined as (a) A1c decrease from baseline of ≥ 1% and/or (b) baseline A1c ≥ 7% with post-index A1c7%. Baseline characteristics of matched cohorts were compared using standardized mean differences (SMDs). Outcome variables were compared using t-tests, chi-square tests, and generalized linear models.Characteristics of 12,882 eligible patients and 12-month persistence rates were similar as defined by method 1 (22.4%) and method 2 (21.1%). After matching, the method 2 cohorts included 2,723 and 8,169 persistent and nonpersistent patients, respectively, with well-balanced baseline characteristics (mean age 53 years; 58% men; all SMDs0.1). All-cause annual medical costs were lower for the persistent cohort (mean $13,499 vs. $17,362;Poor persistence with basal-bolus insulin therapy over 12 months of follow-up was prevalent and was associated with greater medical costs, greater HCRU, and poorer glycemic control than for patients who were persistent. Interventions are needed to improve persistence with insulin therapy and aid patients with T2DM to achieve glycemic control.Funding for this study was provided by Becton, Dickinson and Company (BD). All authors except Edelman are employees and stockholders of BD. Edelman reports board membership at Senseonics and participation in advisory board/speakers bureau at Lilly USA, MannKind, Novo Nordisk, Sanofi-Aventis U.S., Merck, and AstraZeneca, all unrelated to this study. A poster for this study was presented at the AMCP Managed CareSpecialty Pharmacy Annual Meeting 2018; April 23-26, 2018; Boston MA.

Few patients on basal insulin (BI) reach suggested glycemic goals despite repeated dose titration attempts and availability of other support services/medications. An online quantitative survey was used to explore differences between patient and healthcare provider (HCP) priorities and perceptions of therapeutic regimens and approaches. It was completed by 305 T2D patients on BI >1 year and 240 HCPs. Patient and HCP preferences were compared regarding treatment priorities, estimated time to reach A1C goals, impact of not reaching goals, and willingness to change treatment and do more to reach goals. Results showed the similarities and differences in patient and HCP views and priorities. Top patient priorities were to: maintain goals long term (62%), stay healthy (44%), and avoid weight gain (43%) vs. HCPs: avoid side effects (55%), consider treatment affordability (53%), and maintain goals long term (45%). It took longer than expected to meet A1C goals (35% each group); of patients, 49% expected goals would not be met; 61% wanted to reach goals faster; 80% were frustrated by slow progress to reach goals. More patients expected to reach goals in 1-5 years (42% vs. HCPs 16%); both groups wanted to reach goals in 6-12 months. More patients would try harder to reach goals than HCPs expected (37% vs. 16%), be willing to visit their HCP more often (42% vs. 17%), consider treatment changes (40% vs. 18%), and try a different injectable (45% vs. 34%). Within 12 months of starting BI, 17% of patients (vs. 68% of HCPs) expected no treatment addition. More endocrinologists (29% vs. PCPs 16%) anticipated titrating BI dose ≥100 U/day. In patients, 61% felt frustrated not reaching goals on BI, whereas HCPs estimated only 36% of patients would be frustrated. In summary, patients are willing to do more than their HCPs expect. A better understanding of the disparate perceptions and preferences of patients and HCPs could enhance outcomes for T2D patients on BI not reaching glycemic goals and reduce unwarranted complications. Disclosure J. Chamberlain: Speaker's Bureau; Self; Merck & Co., Inc., Novo Nordisk Inc., Sanofi-Aventis. R. Wood: Other Relationship; Self; Multiple companies in the diabetes field (>10 companies). M. Roberts: None. S. Edelman: Advisory Panel; Self; BrightSight, InPen, Lexicon Pharmaceuticals, Inc., Novo Nordisk Inc. Board Member; Self; Senseonics. Speaker's Bureau; Self; AstraZeneca, Lilly Diabetes, MannKind Corporation, Merck Foundation, Sanofi-Aventis. Funding Sanofi U.S.

Around 75% of adults with T1D do not achieve glycemic control, putting them at risk of macrovascular complications. This observational study evaluated prevalence of CVD and cardiovascular risk factors (CVRF) in T1D and the economic impact on U.S. payers. Adults with T1D were identified using previously published criteria and a large health plan claims dataset. Descriptive and multivariate analyses were performed to compare economic outcomes between those with/without CVD/CVRF. A total of 12687 adults with T1D met the study criteria; prevalence of CVD and CVRF were 23% and 42%, respectively. Patients with CVD/CVRF had significantly (P Disclosure S.V. Edelman: Advisory Panel; Self; BrightSight, InPen, Lexicon Pharmaceuticals, Inc., Novo Nordisk Inc. Board Member; Self; Senseonics. Speaker’s Bureau; Self; AstraZeneca, Lilly Diabetes, MannKind Corporation, Merck Foundation, Sanofi-Aventis. F.L. Zhou: Employee; Spouse/Partner; Lexicon Pharmaceuticals, Inc. Employee; Self; Sanofi. Stock/Shareholder; Spouse/Partner; Lexicon Pharmaceuticals, Inc. Stock/Shareholder; Self; Sanofi. R. Preblick: Employee; Self; Sanofi-Aventis. S. Verma: None. S.A. Paranjape: Employee; Self; Sanofi US. M.J. Davies: Employee; Self; Lexicon Pharmaceuticals, Inc. V.N. Joish: Employee; Self; Lexicon Pharmaceuticals, Inc. Funding Sanofi US

OBJECTIVE To assess the burden of disease for adults with type 1 diabetes in a U.S. electronic health record database by evaluating acute and microvascular complications stratified by age and glycemic control. RESEARCH DESIGN AND METHODS This is a retrospective observational study of adults with type 1 diabetes (1 July 2014–30 June 2016) classified using a validated algorithm, with disease duration ≥24 months and, during a 12-month baseline period, not pregnant and having one or more insulin prescriptions and one or more HbA1c measurements. Demographic characteristics, acute complications (severe hypoglycemia [SH], diabetic ketoacidosis [DKA]), and microvascular complications (neuropathy, nephropathy, retinopathy) were stratified by age (18–25, 26–49, 50–64, ≥65 years) and glycemic control (HbA1c RESULTS Of 31,430 patients, ∼20% had HbA1c CONCLUSIONS For adults with type 1 diabetes, glycemic control appears worse than previously estimated. Rates of all complications increased with increasing HbA1c. Compared with HbA1c

Maintenance of glucose homeostasis involves the interplay of multiple glucoregulatory factors, including the pancreatic β-cell hormones insulin and amylin. Amylin, a neuroendocrine hormone, is secreted in response to nutrient intake and suppresses postprandial glucagon secretion, helps regulate gastric emptying, and reduces food intake. Patients with diabetes are deficient in both insulin and amylin - contributing to postprandial hyperglycemia. Pramlintide, an analogue of amylin, is the active ingredient in the SYMLIN® (pramlintide acetate) injection. SYMLIN is indicated as an adjunctive treatment for insulin-using patients with diabetes and works through mechanisms similar to those of amylin. Clinical trials have demonstrated that pramlintide therapy improves postprandial glucose control, lowers A1C, and is accompanied by a reduction in body weight. Mild-to-moderate nausea and an increased risk of insulin-induced severe hypoglycemia have been the most common side effects. These side effects can be mitigated by gradual pramlintide dose escalation during treatment initiation and proactive mealtime insulin dose reduction upon initiation of pramlintide therapy.

Background: The efficacy/safety of device-supported versus routine titration with Gla-300 in type 2 diabetes (T2DM) was evaluated. Method: AUTOMATIX was a 16-week, randomized, open-label, parallel-group, multicenter, noninferiority trial in insulin-treated or insulin-naïve people with T2DM. The fasting self-monitored plasma glucose (FSMPG) target was 90-130 mg/dL (5.0-7.2 mmol/L). Primary endpoint: proportion of participants achieving target FSMPG at week 16 without severe hypoglycemia. Secondary endpoints included: proportion reaching FSMPG target without confirmed (≤70 mg/dL [≤3.9 mmol/L]) or severe hypoglycemia; time to first achieve FSMPG target; mean FSMPG and HbA1c change (baseline to week 16). Safety endpoints included hypoglycemia and adverse events. Patient-reported outcomes (PROs) were also assessed. Results: Participants were randomized to device-supported (n = 75) or routine titration (n = 76); 17 participants in the device-supported group discontinued device use. Noninferiority was achieved for the primary endpoint (device-supported: 45.9%, routine: 36.8%; weighted difference: 9.04 [95% CI: −6.75, 24.83]), but not superiority ( P = .262). The proportion reaching FSMPG target range without confirmed (≤70 mg/dL [≤3.9 mmol/L]) or severe hypoglycemia was 34.3% vs 14.5%, respectively. The time at which 50% of the participants achieved the FSMPG target was less in the device-supported than routine titration arm (10 vs 13 weeks). Least squares mean HbA1c reduction, safety profiles, and PROs were similar in both arms. Mean “ease of use” score for the device, assessed by healthcare professionals and participants on a scale of 1-7, was ≥6. Conclusions: Device-supported self-titration had a good safety/efficacy profile, and was noninferior to routine titration and well accepted by diabetes specialists and patients.

Objective: To understand differences between individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D) in utilization of continuous glucose monitoring (CGM) data to adjust insulin therapy, either continuous subcutaneous insulin infusion (CSII) or multiple daily insulin injections (MDI). Methods: We surveyed 300 individuals who regularly used real-time CGM, using 70 questions to obtain information about general CGM use and response to glucose rate of change (ROC) arrows. Results: The survey was completed by 222 T1D and 78 T2D respondents treated with intensive insulin therapy. T1D respondents included CSII (n = 166) and MDI (n = 56) users. T2D respondents were more balanced: 34 (44%) versus 44 (56%), respectively. A larger percentage of T1D then T2D respondents reported a constant use of CGM (85% vs 61%, P < .001). T1D and T2D respondents reported similar substantial increases in correction dosages in response to rapidly increasing glucose (>3 mg/dL/min; 2 arrows up): +140% versus +136%, P = .4534. However, T1D respondents reported making smaller correction dosage reductions than T2D respondents in response to rapidly decreasing glucose (−42% vs −80%, P < .001). Differences between T1D and T2D respondents were also observed in mealtime dosage adjustments in response to rapidly increasing glucose compared to when glucose is stable (flat arrow) at 110 mg/dl: +81% versus +108%, respectively ( P = .003). Although these adjustments are statistically different, both are large. Conclusions: CGM users often rely on ROC information when determining insulin doses and tend to be more aggressive in their insulin adjustments despite differences in type of diabetes.

Purpose Correct insulin injection technique is a crucial aspect of diabetes management. The purpose of this article is (1) to outline the medical literature, including patient-based studies and surveys, surrounding the type of issues and problems that patients encounter with injectable insulin therapy and the degree to which correct insulin technique is being applied and (2) to review the latest recommendations for insulin injection technique and discuss the key aspects that diabetes educators and other health care professionals should be communicating to their patients to ensure that injection technique is optimized. Conclusions Examination of the literature and multiple patient surveys demonstrates that patients continue to have many issues with insulin injection technique, highlighting the pressing need for effective patient education. In addition, many patients are not using insulin pen devices correctly. Widespread lack of injection site rotation and reuse of needles have resulted in high rates of lipohypertrophy. Lipohypertrophy has in turn been associated with significantly increased levels of unexplained hypoglycemia and glycemic variability and significantly increased insulin costs. By providing clear, evidence-based consensus recommendations, initiatives such as the Forum for Injection Technique are helping to address these issues but will be successful only if concerted efforts in patient education and reeducation are made to ensure that these recommendations are implemented consistently. This should involve all stakeholders in insulin therapy—particularly diabetes educators, who are at the forefront of patient education.

This study was performed to understand and to compare differences in utilization of continuous glucose monitoring (CGM) and the rate of change (ROC) arrow to adjust insulin therapy among individuals with type 1 diabetes (T1D), comparing those treated with multiple daily insulin injections (MDI) with those treated with continuous subcutaneous insulin infusion (CSII).We surveyed 222 T1D individuals who regularly used real-time CGM to obtain information about general CGM use and response to glucose ROC arrows in managing their diabetes.The survey was completed by 222 T1D individuals. Respondents included CSII (n = 166) and MDI (n = 56) users. MDI and CSII respondents reported similar substantial increases in correction dosages (from 220 mg/dL to 120 mg/dL) in response to increasing glucose (one ROC arrow up: rising 2-3 mg/dL/min): +120% and +108%, respectively (P = 0.13). MDI and CSII respondents reported similar substantial increases in correction dosages in response to rapidly increasing glucose (two arrows up: rising3 mg/dL/min): +146% and +138%, respectively (P = 0.72). When correcting from 220 mg/dL to 120 mg/dL, MDI respondents reported larger correction dosage reductions than CSII respondents in response to decreasing glucose (one ROC down arrow: decreasing 2-3 mg/dL/min) and rapidly decreasing glucose (two ROC down arrows: decreasing3 mg/dL/min): -50% versus -37%, respectively (P = .024) and -52% versus 38%, respectively (P = 0.034). Similar between-group differences were observed in mealtime dosage adjustments.CGM users often rely on ROC information when determining insulin doses and tend to make larger changes than current recommendations suggest regardless of insulin delivery method.

Objective: To provide clinicians with an overview of similar biologic products including biosimilars and new insulin versions available in the U.S. and of key issues associated with such products, including differences in manufacturing and regulatory approaches and their impact on clinical use. Methods: We reviewed the relevant clinical and regulatory literature. Results: Patent protections for many biologics including several insulin preparations have or will expire shortly. This opens the door for new insulin versions to enter the U.S. and global marketplace. The development, manufacturing, and approval process for similar biologic products is more complex than for generic versions of small molecules. Most similar biologic products in the U.S. will be submitted for approval under section 351(k), a newly created biosimilar regulatory pathway. However, some biologics, including new insulin versions, will be submitted via the existing 505(b) regulatory pathway. These regulatory pathways have implications for how such products may be labeled, how they may be dispensed, and how patients may perceive them. The immunogenicity of biologics can affect safety and efficacy and can be altered through subtle changes in manufacturing. With the arrival of new insulin versions, health care providers will need to understand the implications of interchangeability, therapeutic equivalence, substitution, switching, and new delivery devices. Conclusion: An understanding of the above topics will be important as physicians, payers, and patients choose between similar versions of a reference listed biologic product. Abbreviations: BLA = biologics license application BPCIA = Biologics Price Competition and Innovation Act EU = European Union FDA = Food and Drug Administration INN = international nonproprietary name NDA = new drug application PD = pharmacodynamic PK = pharmacokinetic PRCA = pure red cell aplasia

To investigate experiences of people with type 2 diabetes (T2DM) at the clinic visit when an additional oral antidiabetes drug (OAD) is prescribed, and how this affects their quality of life, self-management and key outcomes.We surveyed adults with T2DM from a large multinational study of patient-physician communication during early T2DM treatment (IntroDia®). We examined their experiences when an additional OAD is prescribed ("add-on") after initial OAD monotherapy, focusing on 24 key conversational elements, overall patient-perceived communication quality (PPCQ), and associations with current patient-reported outcomes. The links between PPCQ and people's efforts to delay add-on therapy were also assessed.4235 people with T2DM prescribed an additional OAD, or a combination of two, were analysed. Exploratory factor analyses of the conversational elements during add-on yielded three coherent, meaningful factors: Encouraging (Cronbach's α = 0.62), Collaborative (α = 0.81), and Discouraging (α = 0.81). PPCQ was positively associated with Encouraging (β = +1.252, p 0.001) and Collaborative (β = +1.206, p 0.001), but negatively associated with Discouraging (β = -0.895, p 0.001). Better PPCQ at add-on was associated with less diabetes distress, greater well-being and better self-care at the present time. Approximately 20% of people bargained (two-thirds successfully) with their physician to delay additional medication. Non-bargaining individuals reported significantly better mean PPCQ, diabetes distress, well-being and self-care than those who bargained.Encouraging and patient-inclusive conversations at add-on moments may improve patient well-being and self-care outcomes. People with T2DM who attempted to delay additional medication reported poorer PPCQ and outcomes.

Treatment with Afrezza® (insulin human) inhalation powder in individuals with type 1 diabetes (T1D) reduces HbA1c levels similar to rapid-acting insulin analogs, but with significantly less hypoglycemia due to its unique time action profile. Examinations of studies of Afrezza pharmacokinetics/pharmacodynamics, relevant clinical trials, and U.S. Food and Drug Administration (FDA) documentation suggest that current FDA-mandated dosing recommendations for initiating Afrezza treatment may not result in optimal glycemic control for individuals with T1D. Recommendations for initiating Afrezza insulin therapy in T1D patients are presented in this article.

Two types of continuous glucose monitoring (CGM) systems are now available: real-time CGM (rtCGM) and intermittently scanned (isCGM). Current rtCGM systems automatically transmit a continuous stream of glucose data to the user, provide alerts and active alarms, and transmit glucose data (trend and numerical) in real time to a receiver, smart watch, or smartphone. The current isCGM system provides the same type of glucose data but requires the user to purposely scan the sensor to obtain information, and it does not have alerts and alarms. Both CGM technologies have significant advantages over self-monitoring of blood glucose; however, differences in the features and capabilities of the two approaches must be considered when guiding patient selection of the system that meets their individual needs.

Objective: Many healthcare providers in the U.S. are not familiar with follow-on biologics and biosimilars nor with their critical distinctions from standard generics. Our aim is to provide a detailed review of both, with a focus on insulins in the U.S. regulatory system. Methods: Literature has been reviewed to provide information on various aspects of biosimilars and a follow-on biologic of insulin. This will include structure, efficacy, cost, switching, and legal issues. Results: Biologic products are large, complex molecules derived from living sources. Follow-on biologics are copies of the original innovator biologics. It is not possible to copy their structure exactly, leading to possible differences in efficacy and safety. Thus, regulations involving biologics are complex. Follow-on biologics are regulated under two Federal laws until March 23, 2020: the Public Health Service Act (PHS Act) and the Federal Food, Drug, and Cosmetic Act. Biosimilars are follow-on biologics which have been approved via the PHS Act. They consist of those which are "highly similar" to the reference drug and those which are "expected" to produce the same clinical result as the reference drug (interchangeable biosimilars). Interchangeable biosimilars have been determined by the U.S. Food and Drug Administration to be substitutable by the pharmacist "without the intervention" of the prescriber. From the patient perspective, switching to a follow-on biologic may necessitate a change in delivery device, which may create issues for patient adherence and dosing. Conclusion: Although they present several challenges in terms of regulation and acceptance, follow-on biologics have the potential to significantly reduce costs for patients requiring insulin therapy. Abbreviations: BLA = biologics license application EU = European Union FDA = Food and Drug Administration FD&C = Food, Drug, and Cosmetic HCPCS = Healthcare Common Procedure Coding System INN = internatinal nonproprietary name NDA = new drug application PHS = Public Health Service

We thank Giugliano et al. (1) for their comments on our article (2) bringing to light two important issues. First, while we highlighted the importance of problematic medication adherence in diabetes care in our article and briefly examined several of the key contributors, we …

Summary Insulin production by the pancreas follows a basic pattern where basal levels of insulin are secreted during fasting periods, with prandial increases in insulin associated with food ingestion. The aim of insulin therapy in patients with diabetes is to match the endogenous pattern of insulin secretion as closely as possible without causing hypoglycaemia. There are several optimal pharmacokinetic and pharmacodynamic properties of long-acting basal insulins that can help to achieve this aim, namely, as follows: activity that is flat and as free of peaks as possible, a duration of action of ≥24-h, and as little day-to-day variation as possible. The long-acting basal insulins are a fundamental therapy for patients with type 1 and type 2 diabetes, and those that are currently available have many benefits; however, the development of even longer-acting insulins and improved insulin delivery techniques may lead to better glycemic control for patients in the future. Established long-acting basal insulins available in the United States and Europe include insulin glargine 100 units/mL and insulin detemir, both of which exhibit similar glycemic control to that of the intermediate-acting neutral protamine Hagedorn insulin, but with a reduction in hypoglycaemia. Newer insulin products available include new insulin glargine 300 units/mL (United States and Europe) and the ultra-long-acting insulin degludec (Europe) with basal insulin peglispro currently in development. These new insulins demonstrate different pharmacokinetic/pharmacodynamic profiles and longer durations of action (>24 h) compared with insulin glargine 100 units/mL, which may lead to potential benefits. The introduction of biosimilar insulins may also broaden access to insulins by reducing treatment costs. Copyright © 2015 John Wiley & Sons, Ltd.

Aims To identify the hypoglycemic concerns of adults with type 2 diabetes (T2D) and examine how these concerns are associated with key patient characteristics. Methods Qualitative interviews with 16 T2D adults and 11 diabetes care providers were conducted. Survey items were then developed and submitted to exploratory factor analyses (EFAs). Construct validity was assessed by correlations with diabetes distress, anxiety and depressive symptoms, well-being, hypoglycemic fear, hypoglycemia history and glycemic control (A1C). Results An EFA with 226 insulin users and 198 non-insulin users yielded 3 factors (14 items): Hypoglycemia Anxiety, Avoidance and Confidence. For both T2D groups, higher Anxiety and Avoidance were significantly associated with more hypoglycemia, lower well-being, and greater diabetes distress, depressive symptoms and hypoglycemic fear. Similar associations, in the converse direction, were found for Confidence. Among insulin users only, Anxiety was independently associated with greater emotional distress and more hypoglycemia, while Confidence was independently linked to less emotional distress and lower A1C. Avoidance was independently associated with greater emotional distress in both groups. Conclusions Using the new 14-item Hypoglycemic Attitudes and Behavior Scale (HABS), we found that hypoglycemic concerns are significant in T2D adults, are linked to emotional distress and A1C, and merit attention in clinical practice.

Although many different types of insulin delivery devices are currently available, there is no well-accepted, validated method to assess patient satisfaction with these devices and their impact on quality of life and other patient-reported outcomes. To address this problem, we developed the Insulin Device Satisfaction Survey (IDSS) and herein describe its construction and validation. We then examine how key patient factors are associated with device satisfaction.Items were developed from interviews with adults with type 1 diabetes (T1D) (n=10) and type 2 diabetes (T2D) using insulin (n=10), as well as eight healthcare professionals, leading to an initial pool of 32 items. Separate exploratory factor analyses (EFAs) were conducted with T1D subjects (n=279) and insulin-using T2D subjects (n=209). Construct validity was established with overall well-being (World Health Organization-5), diabetes distress (Diabetes Distress Scale), diabetes self-efficacy (Self-Efficacy for Diabetes Management Scale), and subscales from the Insulin Delivery System Rating Questionnaire. Regression analyses examined associations between total scale satisfaction and demographics, insulin adherence, clinical indicators, and device type (pump vs. nonpump users).The two EFAs resulted in a 14-item scale for T1D subjects and a 12-item scale for T2D subjects, with eight items common across both samples. The EFAs yielded three coherent, meaningful factors in each sample, accounting for 55.6% (T1D sample) and 64.1% (T2D sample) of the variance. Validity was established by significant correlations with all criterion variables. For both samples, higher IDSS scores were significantly associated with better glycemic control and greater insulin adherence and pump use. For T2D subjects only, IDDS scores were significantly linked to fewer long-term complications, fewer low blood glucose readings, and older age.The IDSS is a reliable, valid measure of insulin device satisfaction in both its T1D form and T2 form. It provides a comprehensive profile of sources of device satisfaction for use in clinical care and research.

AIMS To investigate physicians' recalled experiences of their conversations with patients at diagnosis of Type 2 diabetes, because physician-patient communication at that time may influence the patient's subsequent self-care and outcomes. METHODS As part of a large cross-national study of physician-patient communication during early treatment of Type 2 diabetes (IntroDia® ), we conducted a cross-sectional survey of physicians treating people with Type 2 diabetes in 26 countries across Africa, Asia, Europe, Latin America, the Middle East, North America and Oceania. The survey battery was designed to evaluate physician experiences during diagnosis conversations as well as physician empathy (measured using the Jefferson Scale of Physician Empathy). RESULTS A total of 6753 of 9247 eligible physicians completed the IntroDia® survey (response rate 73.0%). Most respondents (87.5%) agreed that the conversation at diagnosis of Type 2 diabetes impacts the patient's acceptance of the condition and self-care. However, almost all physicians (98.9%) reported challenges during this conversation. Exploratory factor analysis revealed two related yet distinct types of challenges (r = 0.64, P < 0.0001) associated with either patients (eight challenges, α = 0.87) or the situation itself at diagnosis (four challenges, α = 0.72). There was a significant inverse association between physician empathy and overall challenge burden, as well as between empathy and each of the two types of challenges (all P < 0.0001). Study limitations include reliance on accurate physician recall and inability to assign causality to observed associations. CONCLUSIONS Globally, most physicians indicated that conversations with patients at diagnosis of Type 2 diabetes strongly influence patient self-care. Higher physician empathy was associated with fewer challenges during the diagnosis conversation.

In 2012 U.S. diabetes costs were estimated to be $245 billion, with $176 billion related to direct diabetes treatment and associated complications. Although a few studies have reported positive glycemic and economic benefits for diabetes patients treated under primary care physician (PCP)-pharmacist collaborative practice models, no studies have evaluated the cost-effectiveness of an endocrinologist-pharmacist collaborative practice model treating complex diabetes patients versus usual PCP care for similar patients.To estimate the cost-effectiveness and cost benefit of a collaborative endocrinologist-pharmacist Diabetes Intense Medical Management (DIMM) "Tune-Up" clinic for complex diabetes patients versus usual PCP care from 3 perspectives (clinic, health system, payer) and time frames.Data from a retrospective cohort study of adult patients with type 2 diabetes mellitus (T2DM) and glycosylated hemoglobin A1c (A1c) ≥ 8% who were referred to the DIMM clinic at the Veterans Affairs San Diego Health System were used for cost analyses against a comparator group of PCP patients meeting the same criteria. The DIMM clinic took more time with patients, compared with usual PCP visits. It provided personalized care in three 60-minute visits over 6 months, combining medication therapy management with patient-specific diabetes education, to achieve A1c treatment goals before discharge back to the PCP. Data for DIMM versus PCP patients were used to evaluate cost-effectiveness and cost benefit. Analyses included incremental cost-effectiveness ratios (ICERs) at 6 months, 3-year estimated total medical costs avoided and return on investment (ROI), absolute risk reduction of complications, resultant medical costs, and quality-adjusted life-years (QALYs) over 10 years.Base case ICER results indicated that from the clinic perspective, the DIMM clinic costs $21 per additional percentage point of A1c improvement and $115-$164 per additional patient at target A1c goal level compared with the PCP group. From the health system perspective, medical cost avoidance due to improved A1c was $8,793 per DIMM patient versus $3,506 per PCP patient (P = 0.009), resulting in an ROI of $9.01 per dollar spent. From the payer perspective, DIMM patients had estimated lower total medical costs, a greater number of QALYs gained, and appreciable risk reductions for diabetes-related complications over 2-, 5- and 10-year time frames, indicating that the DIMM clinic was dominant. Sensitivity analyses indicated results were robust, and overall conclusions did not change appreciably when key parameters (including DIMM clinic effectiveness and cost) were varied within plausible ranges.The DIMM clinic endocrinologist-pharmacist collaborative practice model, in which the pharmacist spent more time providing personalized care, improved glycemic control at a minimal cost per additional A1c benefit gained and produced greater cost avoidance, appreciable ROI, reduction in long-term complication risk, and lower cost for a greater gain in QALYs. Overall, the DIMM clinic represents an advanced pharmacy practice model with proven clinical and economic benefits from multiple perspectives for patients with T2DM and high medication and comorbidity complexity.No outside funding supported this study. The authors declare no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Preliminary versions of the study data were presented in abstract form at the American Pharmacists Association Annual MeetingExposition; March 27, 2015; San Diego, California, and the Academy of Managed Care Pharmacy Annual Meeting; April 21, 2016; San Francisco, California. Study concept and design were contributed by Hirsch, Bounthavong, and Edelman, along with Morello and Morreale. Arjmand, Ourth, Ha, Cadiz, and Zimmerman collected the data. Data interpretation was performed by Ha, Morreale, and Morello, along with Cadiz, Ourth, and Hirsch. The manuscript was written primarily by Hirsch and Zimmerman, along with Arjamand, Ourth, and Morello, and was revised by Hirsch and Cadiz, along with Bounthavong, Ha, Morreale, and Morello.

The clinical benefits of real time continuous glucose monitoring (rtCGM) use have been well demonstrated in both CSII- and MDI-treated individuals in large clinical trials. However, recommendations for patient use of rtCGM in everyday life situations are lacking. This article provides guidance to clinicians and patients with type 1 diabetes (T1D) in effective use of rtCGM data, including glucose rate of change (ROC) arrows, for insulin dosing adjustments and other treatment decisions. The recommendations presented here are based on our own clinical experiences as endocrinologists, our personal experiences living with T1D using rtCGM, and findings from a recent survey of T1D patients who have successfully used rtCGM in their self-management. It is important that both clinicians and people with diabetes understand the utility and limitations of rtCGM. Maintaining a collaborative clinician-user relationship remains an important factor in safe, successful rtCGM use.

Despite advances in treatment for type 2 diabetes in recent decades, many patients are failing to achieve adequate glycemic control. Poor glycemic control has been shown to have a detrimental effect on patients' health and well-being, and to have significant negative financial implications for both patients and healthcare systems. Insulin therapy has been proven to significantly reduce glycated hemoglobin levels; however, both patients and physicians can be reluctant to initiate insulin therapy. Research shows that both patient and provider factors contribute to a delay in initiation of insulin therapy. This review discusses the most common barriers contributing to this delay with potential solutions to overcome them.

Purpose Despite many advances in diabetes care over the last century, some elements of insulin therapy remain inadequate for optimal care of the patient with diabetes. There is a need for improved pharmacokinetics and pharmacodynamics of rapid-acting insulin analogues to mimic physiologic insulin secretion. In addition, a major barrier to successful insulin therapy has been patient resistance. Alternative routes of insulin administration, including inhaled insulin, have been under investigation for several years. This review discusses the rationale for pulmonary delivery of insulin, compares previous inhaled insulin products, reviews the literature on the safety and efficacy of a current inhaled insulin formulation under investigation, and compares this product with other prandial insulin products. Methods English-language studies and reviews of inhaled insulin were searched in MEDLINE, the ClinicalTrials.gov registry (through May 2014), and the US Food and Drug Administration Website. Findings Inhaled insulin has several favorable characteristics due to pulmonary anatomy/physiology and the lack of injections. Pharmacokinetic and pharmacodynamic studies have shown a time–action profile suitable for prandial insulin use. Inhaled insulin seems to be safe and effective compared with other prandial insulin products and may be preferable to subcutaneous rapid-acting insulin analogues in terms of time–action profiles and rates of hypoglycemia. Small decreases in forced expiratory volume in 1 second (FEV1) have been shown with inhaled insulin, although this finding is not progressive over time and reverses with cessation of the medication. Implications Although several inhaled insulin products have been under investigation, only one (Exubera ® [Nektar Therapeutics, San Carlos, California/Pfizer Inc, New York, New York]) was approved by the US Food and Drug Administration, and it was pulled from the market after only a short period of time. Technosphere ® insulin (MannKind Corporation, Valencia, California) is currently the only inhaled insulin that remains under investigation. A review of the past and present literature on inhaled insulin is pertinent in understanding the current status of inhaled insulin and its risks and benefits. The current literature suggests that inhaled insulin could be a valuable option for prandial insulin administration, with a favorable risk to benefit ratio in some patients.