Initiation of iGlarLixi Versus Basal-Bolus Insulin in Adults With Type 2 Diabetes Advancing From Basal Insulin Therapy: The SoliComplex Real-World Study.

Background: When type 2 diabetes is suboptimally controlled with basal insulin, prandial insulin injections are commonly added (i.e., a basal-bolus insulin regimen), which can increase treatment burden and hypoglycemia risk. The once-daily injectable iGlarLixi is an alternative treatment. Methods: This retrospective analysis of the U.S. Optum Clinformatics database compared outcomes in adults (≥18 years of age) with type 2 diabetes who previously received basal insulin and were newly initiated on iGlarLixi or basal-bolus insulin therapy. Cohorts were propensity score-matched in a 1:1 ratio on baseline characteristics, and imbalances were adjusted in multivariate analyses. Subgroup analyses were performed for people ≥65 years of age and those with a baseline A1C ≥9%. The primary end point was persistence with therapy at 12 months in the overall population. Secondary end points were treatment adherence, health care resource utilization (HCRU), costs, any hypoglycemia, and A1C change at 12 months. Results: Cohorts each comprised 1,070 participants. Treatment persistence at 12 months was statistically significantly higher for iGlarLixi versus basal-bolus insulin therapy (43.7 vs. 22.3%, hazard ratio 0.51, 95% CI 0.46-0.57, adjusted P <0.001). Adherence was numerically higher for iGlarLixi, and hypoglycemia events, HCRU, and costs were numerically lower for iGlarLixi. A1C reduction from baseline was slightly greater for basal-bolus insulin. Results for both subgroups (≥65 years of age and baseline A1C ≥9%) were similar to those of the overall population. Conclusion: In this observational study, initiation of once-daily iGlarLixi versus basal-bolus insulin was associated with higher persistence, lower hypoglycemia, and similar A1C reduction without increasing HCRU or costs regardless of age or A1C. iGlarLixi could be an alternative to basal-bolus insulin, particularly for older adults with type 2 diabetes who require treatment simplification with lower hypoglycemia risk.

iGlarLixi versus premixed insulin initiation in adults with type 2 diabetes advancing from basal insulin therapy: The SoliComplex real-world study.

AIM: To compare outcomes in adults with type 2 diabetes (T2D) suboptimally controlled with basal insulin who initiated treatment with iGlarLixi or premixed insulin. METHODS: This retrospective real-world analysis was conducted using data from adults (age ≥ 18 years) with T2D in the US Optum Clinformatics database who had previously received basal insulin and newly initiated iGlarLixi or premixed insulin. Cohorts were propensity-score matched on baseline characteristics using a greedy nearest neighbour-matching algorithm, and outcomes were assessed at 12 months. Subgroup analyses were performed for those aged 65 years or older and those with a baseline HbA1c of 9% or higher. The primary endpoint was treatment persistence in the overall population. Secondary endpoints were treatment adherence, healthcare resource utilization (HRU), costs, hypoglycaemia events and change in HbA1c from baseline. RESULTS: Each cohort comprised 834 participants. In the overall population, treatment persistence at 12 months was statistically significantly higher for iGlarLixi versus premixed insulin: 42.5% versus 39.1%; hazard ratio 0.88; 95% confidence interval 0.778-0.998; P = .0465. Adherence and HbA1c reduction were similar between groups, whereas hypoglycaemia events, HRU and costs were numerically lower for iGlarLixi. Outcomes in both the age 65 years or older subgroup and in those with an HbA1c of 9% or higher were consistent with those for the overall population. CONCLUSIONS: In this observational study in people with T2D suboptimally controlled on basal insulin, once-daily iGlarLixi was an effective treatment alternative to premixed insulin with significantly higher treatment persistence, similar adherence and HbA1c reduction, and numerically lower hypoglycaemia events, HRU and costs, regardless of age or baseline HbA1c.

American Association of Clinical Endocrinology Clinical Practice Guideline: The Use of Advanced Technology in the Management of Persons With Diabetes Mellitus.

OBJECTIVE: To provide evidence-based recommendations regarding the use of advanced technology in the management of persons with diabetes mellitus to clinicians, diabetes-care teams, health care professionals, and other stakeholders. METHODS: The American Association of Clinical Endocrinology (AACE) conducted literature searches for relevant articles published from 2012 to 2021. A task force of medical experts developed evidence-based guideline recommendations based on a review of clinical evidence, expertise, and informal consensus, according to established AACE protocol for guideline development. MAIN OUTCOME MEASURES: Primary outcomes of interest included hemoglobin A1C, rates and severity of hypoglycemia, time in range, time above range, and time below range. RESULTS: This guideline includes 37 evidence-based clinical practice recommendations for advanced diabetes technology and contains 357 citations that inform the evidence base. RECOMMENDATIONS: Evidence-based recommendations were developed regarding the efficacy and safety of devices for the management of persons with diabetes mellitus, metrics used to aide with the assessment of advanced diabetes technology, and standards for the implementation of this technology. CONCLUSIONS: Advanced diabetes technology can assist persons with diabetes to safely and effectively achieve glycemic targets, improve quality of life, add greater convenience, potentially reduce burden of care, and offer a personalized approach to self-management. Furthermore, diabetes technology can improve the efficiency and effectiveness of clinical decision-making. Successful integration of these technologies into care requires knowledge about the functionality of devices in this rapidly changing field. This information will allow health care professionals to provide necessary education and training to persons accessing these treatments and have the required expertise to interpret data and make appropriate treatment adjustments.

Sotagliflozin added to optimized insulin therapy leads to HbA1c reduction without weight gain in adults with type 1 diabetes: A pooled analysis of inTandem1 and inTandem2.

AIM: To evaluate whether the addition of sotagliflozin to optimized insulin significantly increases the proportion of adults with type 1 diabetes who achieve HbA1c goals without weight gain. MATERIALS AND METHODS: In a patient-level pooled analysis (n = 1575) of data from two phase 3, 52-week clinical trials (inTandem1 and inTandem2), the change from baseline in HbA1c and weight as well as the proportion of participants achieving an HbA1c of less than 7% without weight gain were compared between groups treated with placebo, sotagliflozin 200 mg and sotagliflozin 400 mg. RESULTS: From a mean baseline HbA1c of 7.7%, mean HbA1c changes at week 24 were -0.36% (95% CI -0.44% to -0.29%) and -0.38% (-0.45% to -0.31%) with sotagliflozin 200 and 400 mg versus placebo (P = .001 for both), respectively, with sustained effects through week 52. Weight significantly decreased at weeks 24 and 52 in both sotagliflozin groups compared with placebo. At week 52, the proportion of patients who achieved an HbA1c of less than 7% without weight gain was 21.8% with sotagliflozin 200 mg, 26.1% with sotagliflozin 400 mg and 9.1% with placebo (P < .001). Other HbA1c, weight and safety composite variables showed similar significant trends. CONCLUSION: When added to optimized insulin therapy, sotagliflozin improved glycaemic control and body weight and enabled more adults with type 1 diabetes to achieve HbA1c goals without weight gain over 52 weeks, although there was more diabetic ketoacidosis relative to placebo.

Combination therapy with SGLT-2 inhibitors and GLP-1 receptor agonists as complementary agents that address multi-organ defects in type 2 diabetes.

Type 2 diabetes (T2D) has a complex pathophysiology composed of multiple underlying defects that lead to impaired glucose homeostasis and the development of macrovascular and microvascular complications. Of the currently available glucose-lowering therapies, sodium-glucose cotransporter-2 inhibitors (SGLT-2is) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) both provide effective glycemic control and have been shown to reduce cardiovascular (CV) events in patients with T2D and a high CV risk or established CV disease. Because these agents have complementary mechanisms of action, they are able to act on multiple defects of T2D when used in combination. This review discusses the rationale for and potential benefits of SGLT-2i plus GLP-1RA combination therapy in patients with T2D. A search of the PubMed database was conducted for studies and reviews describing the combined use of SGLT-2is and GLP-1RAs, with a specific focus on identifying clinical studies of combination therapy in patients with T2D. In clinical studies, glycated hemoglobin (A1c) was significantly reduced over 28-52 weeks with SGLT-2i plus GLP-1RA therapy versus the individual agents or baseline. Several CV risk factors, including body weight, blood pressure, and lipid parameters, were also improved. SGLT-2i plus GLP-1RA therapy was generally well tolerated, with a low risk of hypoglycemia and no unexpected findings. Taken together with results from large CV outcomes trials of SGLT-2is and GLP-1RAs, combination therapy with these agents potentially provides effective durable glycemic control and CV benefits due to their complementary actions on the defects of T2D.

The MARLINA-T2D trial: putting the results into clinical perspective.

Chronic kidney disease (CKD) and type 2 diabetes mellitus (T2D) frequently coexist and are associated with poor clinical outcomes. Dipeptidyl peptidase-4 (DPP-4) inhibitors can be used for patients with T2D and CKD, and preclinical evidence suggests these agents may slow the progression of kidney disease in T2D. Although clinical evidence of the renal effects of DPP-4 inhibitors is limited, the recent publication of the MARLINA-T2D study provided important new data. In MARLINA-T2D, linagliptin was associated with significant improvements in glycemic control with a non-significant reduction in albuminuria and no evidence of renal adverse effects in a high-risk population of patients with T2D and early diabetic kidney disease. Although there was no conclusive evidence of renoprotective effects, previous research suggests that clinically apparent renal benefits might develop with longer term treatment. The results of ongoing trials with primary renal endpoints are awaited with interest.

The role of the new basal insulin analogs in addressing unmet clinical needs in people with type 1 and type 2 diabetes.

BACKGROUND: Despite improvements in anti-hyperglycemic therapies, there are many unmet clinical needs that hinder successful glycemic control in people being treated with current basal insulin analogs. OBJECTIVE: This paper reviews the unmet needs associated with current basal insulin therapy and describes the most recent basal insulins for the treatment of diabetes. METHODS: PubMed was searched for articles on basal insulin analogs published between 2000 and April 2016. RESULTS: Although long-acting insulin analogs, such as insulin glargine 100 units/mL and insulin detemir, have come towards approximating physiologic basal insulin levels, limitations such as hypoglycemia and intra- and inter-individual variability are associated with their use resulting in glycemic fluctuations. Some basal insulins lack 24 hour coverage, requiring some patients to split their dose, increasing the number of injections required to maintain glycemic control. Fear of hypoglycemia and the need for additional injections often leads to poor compliance and suboptimal glycemic control. Long-acting insulin analogs, such as insulin glargine 300 units/mL and insulin degludec, have improved upon the shortcomings of the current basal insulin analogs. Improved pharmacodynamic/pharmacokinetic profiles afford lower intra-patient variability and an extended duration of action, providing full and stable 24 hour basal insulin coverage with once daily dosing, and comparable efficacy to insulin glargine with lower rates of hypoglycemia. CONCLUSION: The improved pharmacodynamic/pharmacokinetic profiles of new long-acting insulin formulations provide greater glycemic control with once daily dosing. With the growing number of therapeutic choices available, physicians have more scope to individualize patient options for basal insulin therapy.

The Clinical and Economic Impact of the V-Go® Disposable Insulin Delivery Device for Insulin Delivery in Patients with Poorly Controlled Diabetes at High Risk.

BACKGROUND: Diabetes is a chronic condition and when poorly controlled can lead to complications and death. Patients with glycated hemoglobin (A1C) measures >9 % are at significant risk for diabetes-related complications impacting the patient's quality of life and imposing higher costs on the healthcare system. A1C reductions of 1 % or greater in this population have demonstrated substantial health and economic benefits. Reducing the percent of patients at risk is an essential component of quality-care measures established for patients with diabetes. OBJECTIVE: To evaluate if switching patients prescribed subcutaneous insulin injections to V-Go for insulin delivery would impact clinical and economic parameters in patients with poorly controlled diabetes (A1C > 9 %). METHODS: The study was a retrospective analysis using data extracted from the electronic medical records database of a multicenter diabetes system. Outcome measures included mean change in A1C from baseline, the percent of patients achieving a reduction in A1C ≥1 % while on V-Go therapy, and the impact to quality measures. In addition, economic analyses were conducted to assess the pharmacy budget impact and projected implication to total healthcare cost. RESULTS: Ninety-seven patients were evaluated after a mean duration of 13.6 ± 6.9 weeks of insulin delivery with V-Go. Switching to V-Go resulted in an overall mean change (95 % CI) in A1C of -2.0 % (-1.7 to -2.3; p < 0.001) from a baseline of 10.5 %. Seventy-three percent of patients achieved an A1C reduction ≥1 %. Cost analysis supported a direct pharmacy savings of $119.30 (18.80-219.60, p = 0.020) per patient per month compared with baseline. CONCLUSION: Switching to V-Go for insulin delivery resulted in significant glycemic improvement and proved cost effective. This real-world assessment could be applied more broadly at the health system and plan level.

CLINICAL AND COST-EFFECTIVENESS OF INSULIN DELIVERY WITH V-GO(®) DISPOSABLE INSULIN DELIVERY DEVICE VERSUS MULTIPLE DAILY INJECTIONS IN PATIENTS WITH TYPE 2 DIABETES INADEQUATELY CONTROLLED ON BASAL INSULIN.

OBJECTIVE: To compare two methods of delivering intensified insulin therapy (IIT) in patients with type 2 diabetes inadequately controlled on basal insulin ± concomitant antihyperglycemic agents in a real-world clinical setting. METHODS: Data for this retrospective study were obtained using electronic medical records from a large multicenter diabetes system. Records were queried to identify patients transitioned to V-Go(®) disposable insulin delivery device (V-Go) or multiple daily injections (MDI) using an insulin pen to add prandial insulin when A1C was >7% on basal insulin therapy. The primary endpoint was the difference in A1C change using follow-up A1C results. RESULTS: A total of 116 patients were evaluated (56 V-Go, 60 MDI). Both groups experienced significant glycemic improvement from similar mean baselines. By 27 weeks, A1C least squares mean change from baseline was -1.98% (-21.6 mmol/mol) with V-Go and -1.34% (-14.6 mmol/mol) with MDI, for a treatment difference of -0.64% (-7.0 mmol/mol; P = .020). Patients using V-Go administered less mean ± SD insulin compared to patients using MDI, 56 ± 17 units/day versus 78 ± 40 units/day (P<.001), respectively. Diabetes-related direct pharmacy costs were lower with V-Go, and the cost inferential from baseline per 1% reduction in A1C was significantly less with V-Go ($118.84 ± $158.55 per patient/month compared to $217.16 ± $251.66 per patient/month with MDI; P = .013). CONCLUSION: Progression to IIT resulted in significant glycemic improvement. Insulin delivery with V-Go was associated with a greater reduction in A1C, required less insulin, and proved more cost-effective than administering IIT with MDI. ABBREVIATIONS: A1C = glycated hemoglobin ANCOVA = analysis of covariance CI = confidence interval CSII = continuous subcutaneous insulin infusion FPG = fasting plasma glucose IIT = intensified insulin therapy LSM = least squares mean MDI = multiple daily injections T2DM = type 2 diabetes mellitus TDD = total daily dose.

Use of V-Go® Insulin Delivery Device in Patients with Sub-optimally Controlled Diabetes Mellitus: A Retrospective Analysis from a Large Specialized Diabetes System.

INTRODUCTION: Tight glycemic control and timely treatment can improve outcomes in patients with diabetes yet many remain sub-optimally controlled. The objective of the current study was to evaluate the effect of switching patients with sub-optimally controlled diabetes to the V-Go® (Valeritas Inc., Bridgewater, NJ, USA) Disposable Insulin Delivery device. METHODS: A retrospective analysis of electronic medical records was conducted to assess patients with sub-optimal glycemic control defined as a glycated hemoglobin (HbA1c) >7%, switched to V-Go. Blood glucose control defined as change from baseline in HbA1c, prescribed insulin doses, body weight, concomitant anti-hyperglycemic agents, and reported hypoglycemia were collected prior to switching to V-Go and during V-Go use. RESULTS: Two-hundred and four patients were evaluated during the study period. Overall, there was a significant decrease in HbA1c after switching to V-Go at the 14- and 27-week follow-up visits. The least-squares mean (LSM) change in HbA1c (95% confidence interval) from baseline to 14 weeks was -1.53% (-1.69% to -1.37%; P < 0.001), and from baseline to 27 weeks was -1.79% (-1.97% to -1.61%; P < 0.001). Significant reductions in mean HbA1c were achieved at both visits in all patient subsets: Patients with type 2 and type 1/latent autoimmune diabetes in adults (LADA); patients using insulin at baseline and patients naïve to insulin at baseline. Patients administering insulin at baseline required significantly less insulin on V-Go (86-99 LSM units/day at baseline to 58 LSM units/day at 27 weeks; P < 0.001). Across all patients, reported hypoglycemic events were no more frequent on V-Go than on previous therapy. CONCLUSION: V-Go is safe and effective in patients with sub-optimally controlled diabetes requiring insulin therapy. Glycemic control improved significantly, less insulin was required, and hypoglycemic events were similar after patients switched to insulin delivery by V-Go. FUNDING: Valeritas, Inc.

Efficacy and safety of linagliptin in Hispanic/Latino patients with type 2 diabetes mellitus: a pooled analysis from six randomized placebo-controlled phase 3 trials.

OBJECTIVE: The number of individuals diagnosed with type 2 diabetes mellitus is expected to rise disproportionately in Hispanic/Latino populations. We therefore aimed to assess the efficacy and safety of the dipeptidyl peptidase-4 inhibitor linagliptin specifically in Hispanic/Latino patients with type 2 diabetes mellitus. RESEARCH DESIGN AND METHODS: Data from 745 patients who self-identified their ethnicity as Hispanic or Latino were pooled from six randomized, placebo-controlled phase 3 trials. Participants received linagliptin (5 mg/day) or placebo as monotherapy, or in combination with other oral antidiabetes drugs for 18 or 24 weeks. RESULTS: The placebo-adjusted mean change (95% CI) in glycated hemoglobin from baseline (mean 8.2%) was -0.63% (-0.77 to -0.48; p<0.0001) at week 18, and -0.58% (-0.74 to -0.42; p<0.0001) at week 24. The placebo-adjusted mean change (95% CI) in fasting plasma glucose from baseline was -11.7 mg/dL (-19.3 to -4.0; p=0.0028) at week 18 and -14.1 mg/dL (-22.0 to -6.3; p=0.0004) at week 24. Hypoglycemia incidence was 17.4% with linagliptin and 21% with placebo. In patients not receiving concomitant sulfonylurea, the hypoglycemia incidence was 10.1% with linagliptin and 19.4% with placebo. The overall incidence of adverse events (AEs), drug-related AEs, and serious AEs with linagliptin was similar to placebo (AEs 67.6% vs 68.9%; drug-related AEs 15.1% vs 18.7%; serious AEs 3.6% vs 3.0%). The mean body weight remained unchanged in both groups. CONCLUSIONS: In Hispanic/Latino patients with inadequately controlled type 2 diabetes mellitus, linagliptin provided clinically meaningful improvements in glycemic control without weight gain or increased risk of hypoglycemia.

The potential role of sodium glucose co-transporter 2 inhibitors in combination therapy for type 2 diabetes mellitus.

INTRODUCTION: Sodium glucose co-transporter 2 (SGLT2) inhibitors are a new class of glucose-lowering agents developed for the treatment of type 2 diabetes mellitus (T2DM). These agents have a mechanism of action that is independent of pancreatic ß-cell function or the degree of insulin resistance; consequently, SGLT2 inhibitors have the potential to be used not only as monotherapy but also in combination with any of the existing classes of glucose-lowering agents, including insulin. As part of the extensive clinical development programs for modern T2DM therapies, SGLT2 inhibitors have been studied in combination with the most commonly used classes of glucose-lowering medications. AREAS COVERED: This report summarizes the key clinical trials data for combination therapies using SGLT2 inhibitors currently approved in the United States and/or the European Union, namely, dapagliflozin, canagliflozin, and empagliflozin. EXPERT OPINION: When given as add-on combination therapy with other glucose-lowering agents, or as monotherapy, SGLT2 inhibitors produced modest but clinically meaningful reductions in glycated hemoglobin, body weight, and systolic blood pressure. These changes have been sustained over long-term follow-up. SGLT2 inhibitors have a generally favorable safety profile similar to that of placebo, and are well tolerated. The risk of hypoglycemia appears to depend on coadministered glucose-lowering agents: when used as monotherapy, the frequency is comparable to that of placebo, but an increased risk is associated with concomitant use of sulfonylureas or insulin. In addition, an increased risk of genitourinary infections has been reported with SGLT2 inhibitors. However, these infections are usually mild, nonrecurrent, and respond to standard treatment.

Efficacy and safety of linagliptin in subjects with long-standing type 2 diabetes mellitus (>10 years): evidence from pooled data of randomized, double-blind, placebo-controlled, phase III trials.

PURPOSE: Long duration of type 2 diabetes mellitus (T2DM) is associated with progressive ß-cell loss and may pose a challenge to maintenance of good glycemic control. This study aimed to assess the efficacy and safety of the dipeptidyl peptidase-4 inhibitor linagliptin in an understudied population of patients with long-standing T2DM. METHODS: Data from 202 individuals with T2DM for >10 years were pooled from 2 randomized, placebo-controlled, Phase III trials. Participants received either linagliptin 5 mg once daily (n = 122) or placebo (n = 80) for 24 weeks as an add-on to their current glucose-lowering therapy. FINDINGS: Long-standing T2DM was associated with older age (mean [SD], 69.1 [10.0] years) and a high prevalence of diabetes-related complications (78% with diabetic kidney disease and 83% with macrovascular disease). The mean baseline glycosylated hemoglobin (HbA1c) level was 8.22% (1.08%), and mean baseline fasting plasma glucose level was 161.8 (49.2) mg/dL. Linagliptin significantly improved glycemic control after 24 weeks, with a placebo-adjusted mean change in HbA1c from baseline of -0.66% (95% CI, -0.95 to -0.38; P < 0.0001). This change was accompanied by a significant reduction in fasting plasma glucose, with a placebo-adjusted mean change from baseline of -15.5 mg/dL (95% CI, -29.6 to -1.3; P = 0.0323) at week 24. Overall, linagliptin was well tolerated, with drug-related adverse events in 21.3% and 16.3% of the linagliptin and placebo groups, respectively. Investigator-reported hypoglycemia occurred more often with linagliptin (25.4%) compared with placebo (12.5%). However, no severe hypoglycemic events were reported with linagliptin. Moreover, in patients not receiving concomitant sulfonylureas, the incidence of hypoglycemia with linagliptin (12.5%) was similar to that with placebo (12.2%). Patients' mean weight remained unchanged in both groups. IMPLICATIONS: This pooled analysis found that linagliptin was well tolerated and significantly improved hyperglycemia in a clinically challenging population of patients with long-standing T2DM (>10 years). Although T2DM is commonly associated with diminished ß-cell function, the extent of glucose lowering was similar to that in linagliptin trials, which largely included patients in earlier stages of the disease. Thus, this observation supports the hypothesis that regulation of glucagon release from pancreatic α cells may be of particular relevance for improving hyperglycemia in patients with long-term T2DM (NCT01194830 and NCT01084005).

Use of the dipeptidyl peptidase-4 inhibitor linagliptin in combination therapy for type 2 diabetes.

INTRODUCTION: Most patients with type 2 diabetes mellitus (T2DM) are prescribed multiple medications - typically more than one for glycemic control alone, and others for the management of lipids and hypertension. Within a few years following diagnosis, many patients progress beyond an initial starting regimen of metformin and/or sulfonylurea in order to maintain glycemic control. With the broad selection of antidiabetes medications available today, the choice of which agents to add when progressing from monotherapy to combination therapy has led to much discussion on how to best tailor a treatment regimen to the individual patient's needs. AREAS COVERED: The aim of this paper is to review the literature describing the use of linagliptin as a component of combination therapy for the treatment of T2DM. Literature searches were conducted to retrieve articles reporting on linagliptin clinical trial data. For comparison of safety and efficacy, studies of linagliptin as monotherapy were included. EXPERT OPINION: Dipeptidyl peptidase-4 inhibitors are used across all stages of treatment, from monotherapy to dual or triple therapy regimens for glycemic control. Linagliptin has been studied in combination with the most commonly used classes of antihyperglycemic medications, with demonstrated efficacy and a safety profile comparable to placebo.

Healthcare professional and patient perceptions of a new prefilled insulin pen versus vial and syringe.

OBJECTIVE: Usability of a new prefilled insulin pen, FlexTouch® (FT; Novo Nordisk A/S, Bagsvaerd, Denmark), with no push-button extension and low injection force, was compared with vial and syringe (V&S). RESEARCH DESIGN AND METHODS: People with diabetes, and healthcare professionals with diabetes management experience conducted test injections and answered questions on preference, ease of use, confidence, ease of learning and teaching. RESULTS: The study involved 30 needle-naïve patients (naïve to any diabetes injection therapy), 30 V&S-experienced patients, 30 physicians and 30 nurses. In the total population, FT was preferred to V&S for teaching or learning to use (both p < 0.001). Nurses (100 vs. 0%) and physicians (87 vs. 7%) preferred FT to V&S for ease of teaching. V&S-experienced (73 vs. 7%) and needle-naïve patients (83 vs. 7%) preferred FT to V&S for ease of learning. The remainder chose "equally easy/difficult." More participants in each group rated FT "very/fairly easy" for ease of depressing the push-button/plunger (FT vs. V&S: physicians, 93 vs. 80%; nurses, 97 vs. 80%; V&S-experienced patients, 93 vs. 90%; needle-naïve patients, 100 vs. 77%), and injecting three doses. More participants were "very/rather confident" in managing daily injections using FT (FT vs. V&S: physicians, 100 vs. 60%; nurses, 100 vs. 70%; V&S-experienced patients, 93 vs. 90%; needle-naïve patients, 90 vs. 40%). CONCLUSIONS: FT was rated easier to use, learn to use or teach to use than V&S by patients with or without experience of insulin injection with V&S, and by physicians and nurses with diabetes management experience.

Usability and preference assessment of a new prefilled insulin pen versus vial and syringe in people with diabetes, physicians and nurses.

OBJECTIVE: This multicenter, crossover study assessed the preference and usability of a new prefilled insulin pen, FlexTouch® (FT) versus vial and syringe (V&S). RESEARCH DESIGN AND METHODS: People with type 1 or type 2 diabetes (n = 60), and physicians (n = 30) and nurses (n = 30) with experience of diabetes management performed test injections with FT and V&S, and then answered written questions on ease of use and preference. MAIN OUTCOME MEASURES: The primary end point was preference for FT versus V&S. Secondary end points included perceptions of device handling. RESULTS: Significantly more respondents preferred using FT (88%) to V&S (5%; p < 0.001; the remainder chose 'no preference'), found FT (91%) easier to use than V&S (6%; p < 0.001; the remainder chose 'no preference') and would recommend FT (91%) over V&S (3%; p < 0.001; the remainder chose 'no preference'). FT received better ratings than V&S for ease of use, holding the device stable when injecting, depressing the push-button/plunger and reading the dose scale (all p < 0.001). Ratings for confidence in correct insulin delivery and controlling blood sugar were also significantly better with FT (both p < 0.001). CONCLUSIONS: FT was preferred to V&S for insulin delivery in this comparative analysis. The features of FT may improve the experience of insulin injection compared with V&S for a wide range of people with diabetes.