Treatment Satisfaction Questionnaire Status Version Research Articles

1586. Phase 3/3b Experience with Long-Acting Cabotegravir and Rilpivirine: Efficacy and Safety Outcomes Through Week 96 by Race

Abstract Background Long-acting cabotegravir + rilpivirine (CAB + RPV LA) administered monthly or every 2 months is the first and only complete LA regimen recommended by treatment guidelines for the maintenance of HIV-1 virologic suppression. This post hoc analysis summarizes pooled outcomes for participants in the FLAIR and ATLAS-2M global Phase 3/3b studies through Week (W) 96 by race. Methods Data from participants randomized to receive CAB + RPV LA every 4 weeks (Q4W) or 8 weeks (Q8W) in the FLAIR and ATLAS-2M studies were pooled and stratified by race (Black or African American, White, Asian, Other race). Key efficacy endpoints were the proportion of participants with plasma HIV-1 RNA ≥50 copies/mL and HIV-1 RNA < 50 copies/mL at W96 (FDA Snapshot). Incidence of confirmed virologic failure (CVF; two consecutive HIV-1 RNA measurements of ≥200 copies/mL), safety, and treatment satisfaction (HIV Treatment Satisfaction Questionnaire status version [HIVTSQs]) were also assessed. Results 937 participants received CAB + RPV LA (Q8W, n=327; Q4W, n=610). Overall, 76% (n=711) of participants were White, 16% (n=149) were Black or African American, 4% (n=41) were Asian, and 4% (n=36) were Other race. The median age (range) was 39 years (19–83), and 23% (n=211) were female (sex at birth) (Table 1). At W96, rates of virologic non-response (HIV-1 RNA ≥50 copies/mL) and suppression (HIV-1 RNA < 50 copies/mL) with CAB + RPV LA ranged 0–3% and 83–94%, respectively, across races (Table 2). Rates of CVF ranged 0–2% across races. Excluding injection site reactions (ISRs), drug-related Grade ≥3 adverse events (AEs) occurred in 2% (n=17/937) of participants, ranging 0–3% across races. Drug-related serious AEs occurred in 5 (< 1%) participants (White, < 1% [n=4]; Other race, 3% [n=1]). Overall, 99% (n=8357/8453) of ISR events were Grade 1 or 2; 2% (n=20) of participants withdrew for injection-related reasons. Mean changes in HIVTSQs total scores increased from baseline to W96 across all races, ranging 0.9–3.0. Conclusion CAB + RPV LA demonstrated high efficacy and was well tolerated, with increases in participant satisfaction reported from baseline, irrespective of race. These data support CAB + RPV LA as a complete regimen for the maintenance of virologic suppression in individuals with HIV-1. Disclosures Parul Patel, MSW, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare Ltd: Employee Emilie Elliot, MD, ViiV Healthcare Ltd: Employee Ronald D’Amico, D.O., MSc, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare Ltd: Employee Louise Garside, PhD, GlaxoSmithKline: Stocks/Bonds Jeremy Roberts, MSc, GlaxoSmithKline: Employee|GlaxoSmithKline: Stocks/Bonds Joseph W. Polli, PhD, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare Ltd: Employee Moti Ramgopal, MD, FACP, FIDSA, AbbVie: Grant/Research Support|Gilead Sciences Inc.: Advisor/Consultant|Gilead Sciences Inc.: Grant/Research Support|Gilead Sciences Inc.: Honoraria|Gilead Sciences Inc.: Stocks/Bonds|GlaxoSmithKline: Advisor/Consultant|GlaxoSmithKline: Grant/Research Support|GlaxoSmithKline: Honoraria|GlaxoSmithKline: Stocks/Bonds|Janssen Research & Development LLC: Advisor/Consultant|Janssen Research & Development LLC: Grant/Research Support|Janssen Research & Development LLC: Honoraria|Janssen Research & Development LLC: Stocks/Bonds|Merck: Advisor/Consultant|Merck: Grant/Research Support|Merck: Honoraria|Merck: Stocks/Bonds|Shionogi: Grant/Research Support|ViiV: Advisor/Consultant|ViiV: Grant/Research Support Princy N. Kumar, MD, American Gene Technologies: Grant/Research Support|BioHaven: Grant/Research Support|Eli Lilly: Grant/Research Support|Gilead: Advisor/Consultant|Gilead: Grant/Research Support|Gilead: Stocks/Bonds|GSK: Grant/Research Support|GSK: Stocks/Bonds|Johnson&Johnson: Advisor/Consultant|Johnson&Johnson: Stocks/Bonds|Merck: Advisor/Consultant|Merck: Grant/Research Support|Merck: Stocks/Bonds|Moderna: Stocks/Bonds|Pfizer: Stocks/Bonds|Regeneron: Grant/Research Support|TheraTechnologies: Advisor/Consultant|ViiV: Advisor/Consultant Olayemi Osiyemi, MD, Gilead: Advisor/Consultant|gsk: Advisor/Consultant|viiv: Advisor/Consultant Bryan Baugh, MD, Janssen Research & Development LLC: Employee|Janssen Research & Development LLC: Stocks/Bonds Jean A. van Wyk, MB,ChB; MFPM, ViiV Healthcare Limited: I am an employee of ViiV Healthcare|ViiV Healthcare Limited: Stocks/Bonds.

ODP608 Quality of Life and Treatment Satisfaction in Patients with Type 1 Diabetes Experiencing Different Models of Care in Saudi Arabia

Abstract Background Little is known about the model of care affecting quality of life(QoL)and treatment satisfaction among people with type 1 diabetes(PWT1D). Objectives To compare QoL, treatment satisfaction and cardiometabolic indices among PWT1D receiving different care models in Saudi Arabia. Methods QoL was measure using Audit of Diabetes Dependent Quality of Life(ADDQoL) and treatment satisfaction was measure using Diabetes Treatment Satisfaction Questionnaire status version(DTSQs). Out of 177 respondents to internet validated Arabic versions of ADDQoL and DTSQs,105 are receiving care at specialized diabetes clinics(SDC), whereas 72 are receiving traditional care at general endocrine clinics(GEC). In SDC,where care is delivered jointly by an interdisciplinary team,PWT1D are evaluated from their first visit simultaneously and thereafter as recommended by 6 care providers: diabetes specialist,educator,podiatrist,nutritionist,optometrist, and mental health specialist, while in GEC, PWT1D will be followed every 6-12months and referred to other services as needed where referrals require a long waiting period. ADDQoL and DTSQs scores,sociodemographic characteristics, and cardiometabolic indices were compared between the two groups. The association between patients’ characteristics and their ADDQoL and DTSQs scores were examined. Results Among the respondents,109(61.6%)females,132(74.6%)never married,136(76.8%) belongs to age group(18-30)years old, with a mean duration of diabetes(11.4±7.5years). Both groups are comparable across nearly all sociodemographic characteristics except for half of the SDC attendees reported higher income categories(≥10000 Saudi Riyals)(51.4%vs. 23.6%,p<0. 001). Compared to participants in GEC, larger proportion of participants in SDC use insulin pump(29% vs. 0%, p<0. 0001),continuous glucose monitoring(CGM)(73.3%vs. 13.9%, p<0. 0001),have higher body mass index(26.3±6.4 kg/m2vs. 24.1±5.1 kg/m2,p=0. 016),and lower HbA1c(8.3±1.6%vs. 9.3±2.4%, p=0. 004). Receiving care in SDC is associated with higher DTSQs score(30.5±5.1vs. 26.2±7.9, p<0. 0001),lower level of negative impact of diabetes on ADDQoL score(-2.2±1.9vs. -3.5±2.4, p<0. 0001). Irrespective of clinic type, using insulin pump and CGM is associated with both higher DTSQs score(insulin pump(32±3.9)vs. MDI(28.5±7), p=0. 029), CGM(30.5±5.5)vs. glucometer(27.9±7.1), or not monitoring (22. 0±9.2), p<0. 0001), and lower negative impact of diabetes on ADDQoL score(insulin pump(-1.3±1.1)vs. MDI(-2.9±2.3), p=0. 002),(CGM (-2.3±2.1)vs. glucometer(-3.1±2.4),or not monitoring(-3.5±2.2), p=0. 036). Another factor associated with a higher DTSQs score is: (being never married (29.3±6.5), or married(28.7±7)vs. divorced/widow(20.6±4.7), p=0. 018), whereas other factors associated with lower level of negative impact of diabetes on ADDQoL score are: (younger age(18-30years(-2.5±2.2),or 31-40years(-3.1±2. 0)vs. >40years(-4.4±2.8), p=0. 013)),(being never married(-2.5±2.1)vs. married(-3.4±2.3),or divorced/window(-4.7±3.3), p=0. 010),(having bachelor degree or more (-2.4±1.9) vs. less than bachelor degrees (secondary school(-3.2±2.7),primary school(-3.9± 4.8),intermediate school(-5. 0±2.4), p=0. 005),and(being student(-2.2±1.9)vs. employed(-3.2±2.4), or unemployed(-3.2±2.5), p=0. 010). Conclusion QoL, treatment satisfaction and glycemic control among PWT1D can be enhanced by providing structured care and using devices(insulin pump and CGM). This necessitates a call for healthcare policymakers to utilize the existing health resources to optimize care for PWT1D. Presentation: No date and time listed

Quality of life and other patient-reported outcomes in adult Lebanese patients with type 2 diabetes during COVID-19 pandemic.

IntroductionSeveral studies have shown that COVID-19 pandemic has a negative impact on type 2 diabetic mellitus (T2DM) patients’ quality of life (QoL). However, very few studies were performed in Middle Eastern countries.AimThe aim of the current study was to assess, the QoL and diabetes-specific QoL, treatment satisfaction and psychological distress of Lebanese patients with T2DMs using: the Audit of Diabetes-Dependent Quality of Life (ADDQoL), Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) and Kessler 10 (K10) questionnaires and to compare results to those obtained during the pre-COVID-19 period.Results461 patients with T2DM participated in the study; 52.6% men, 47.4% women; median age 59 years old. The respective median ADDQoL and DTSQs scores were − 2.2 (interval interquartile range (IQR) − 3.9, − 0.8) (range from − 9 maximum negative impact to + 3 maximum positive impact) and 30(IQR22-36) (range from 0 maximum dissatisfaction to 36 maximum satisfaction). K10 median score was 26(IQR18-35) (range from minimum score of 10 indicating no distress to maximum score of 50 indicating severe distress). Rural dwelling, lack of exercise, current smoking, diabetic complications, injectable diabetes treatment, and previous COVID-19 infection were all associated with significantly worse ADDQoL, DTSQs, and K10 score indicating greater distress. A significant worsening of ADDQoL scores followed onset of the pandemic with no significant change in DTSQs scores.ConclusionDuring the COVID-19 pandemic, T2DM Lebanese patients experienced more negative impact of diabetes on QoL and mental health. Those infected with COVID-19 also reported worse QoL, treatment satisfaction and mental health. This highlights the need for community and individual support.

Hypoglycemia frequency and treatment satisfaction in patients receiving insulin analogues for treatment of type 1 diabetes mellitus.

The aim of this study was to evaluate the frequency of hypoglycemia and the treatment satisfaction in patients with type 1 diabetes (T1D) using insulin analogues. This observational retrospective study included 516 adult patients with T1D from 38 cities in Southern Brazil. Demographics and clinical data were collected using a self-report questionnaire. Hypoglycemia was defined as an event based on either symptoms or self-monitored blood glucose < 70 mg/dL. Treatment satisfaction was evaluated using the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) and with a specific question with scores ranging from 0-10. Common mental disorders were assessed using the General Health Questionnaire (GHQ-12). Overall, the mean age was 38 ± 14 years and 52% of the participants were women. The median diabetes duration was 18 years. The scores for insulin analogue treatment satisfaction were higher than those for previous treatments. DTSQ scores had a median value of 32 (interquartile range 29-35) and remained unchanged over time. The percentage of patients with hypoglycemia (including severe and nocturnal) was comparable across groups divided according to duration of use of insulin analogues. Most patients (n=395, 77%) screened positive for common mental disorders. Patient satisfaction with insulin analogue treatment was high and remained unchanged with time. Episodes of hypoglycemia also remained unchanged over time among patients using insulin analogues.

1035. Patient-Reported Outcomes on Long-Acting Cabotegravir + Rilpivirine as Maintenance Therapy: FLAIR 96-Week Results

BackgroundIn the phase 3 FLAIR study, switching to monthly injectable long-acting (LA) cabotegravir (CAB) + rilpivirine (RPV) was noninferior to continued daily oral dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) for the maintenance of virologic suppression over 96 weeks in adults with HIV-1. Key patient-reported outcomes (PROs) through Week 96 are presented.MethodsIn FLAIR, ART-naive adult participants received induction therapy with oral DTG/ABC/3TC for 20 weeks. Those with HIV-1 RNA < 50 c/mL at 16 weeks were randomized (1:1) to continue DTG/ABC/3TC or receive monthly CAB + RPV LA injections after a 4-week lead-in with daily oral CAB + RPV through Week 96. Treatment satisfaction (HIV Treatment Satisfaction Questionnaire status version [HIVTSQs]) and acceptability of injections (Perception of Injection [PIN] Questionnaire) up to Week 96 were secondary endpoints.ResultsA total of 566 participants were randomized (median age, 34 years; 22% female); baseline characteristics were similar between treatment groups. At Week 96, significantly greater improvement from baseline in total treatment satisfaction score was observed in the CAB + RPV LA vs DTG/ABC/3TC treatment group (adjusted mean difference, 2.3 [95% CI, 1.1-3.5]; P< 0.001), further increasing from Weeks 24 (2.1 [0.9-3.3]) and 44 (0.7 [−0.4, 1.9]). Key drivers for the difference in HIVTSQs between treatment groups were items assessing convenience, flexibility, and satisfaction to continue with LA therapy. In participants receiving CAB + RPV LA, mean score for the “Acceptability of ISRs” dimension of PIN (scale, 1-5) significantly decreased (improved) from Week 5 to Weeks 41, 48, and 96 (2.08 to 1.71, 1.66, and 1.71, respectively; P< 0.001 for all). In addition, 82% and 85% of LA participants, respectively, rated pain and local reactions due to injections as “totally” or “very acceptable” at Week 96.ConclusionAt Week 96, FLAIR participants receiving LA therapy reported greater improvement in treatment satisfaction compared with participants continuing on daily oral medication as well as overall good acceptability of injections with improvement over time. Overall, these results support monthly CAB + RPV LA as an alternative to daily oral regimens for adults with HIV-1.DisclosuresVasiliki Chounta, MSc, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Sharon Walmsley, FRCPC, MD, MSC, GSK (Grant/Research Support)ViiV Healthcare (Grant/Research Support) David Dorey, MMATH, GlaxoSmithKline Inc. (Employee, Shareholder) William Spreen, PharmD, ViiV Healthcare (Employee, Shareholder) Sandy Griffith, PharmD, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) David Margolis, MD, MPH, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee)

Improvement in Patient-Reported Outcomes in Adults with Type 1 Diabetes Treated with Sotagliflozin plus Insulin Versus Insulin Alone

Background: Diabetes-related distress is common among persons affected by diabetes and is associated with suboptimal glycemic control and complications, thus constituting a relevant patient-report outcome (PRO). Improving glycemic control may reduce diabetes distress and improve treatment satisfaction. This post hoc analysis evaluated PRO data for a pooled cohort of adults with type 1 diabetes (T1D) receiving sotagliflozin as adjunct to optimized insulin in the inTandem1 and inTandem2 studies. Methods: Clinically meaningful changes in the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) and the two-item Diabetes Distress Scale (DDS2) total and individual scores were examined in the pooled data from the first 24 weeks of the studies. Results: In the cohort of patients with a baseline DTSQs total score ≤32 (∼76% of entire cohort), nearly twice as many patients treated with sotagliflozin 200 (45.9%) or 400 mg (42.3%) experienced a >3-point improvement from baseline versus those treated with placebo (24%). Treatment with sotagliflozin led to statistically significant (P < 0.05) improvements across all DTSQs items. Approximately 42% of all patients were considered to have a high risk of diabetes distress (total DDS2 score ≥6) at baseline following insulin optimization. More patients shifted from high to low risk with sotagliflozin compared with placebo (∼40% vs. 23%; P ≤ 0.0002). The baseline-adjusted difference in DDS2 from placebo was significantly (P < 0.001) reduced by -0.5 and -0.6 for sotagliflozin 200 and 400 mg, respectively. Conclusions: Patients with T1D treated with sotagliflozin in addition to optimized insulin therapy reported meaningful improvements in treatment satisfaction and diabetes distress. NCT02384941 and NCT02421510.

Patient-Reported Outcomes with Insulin Glargine 300U/mL in People with Type2 Diabetes: The MAGE Multicenter Observational Study.

IntroductionMAGE was a Multicenter, single-Arm, observational 6-month (plus 6-month extension) study that aimed to assess treatment satisfaction, efficacy, and safety of insulin Glargine 300 U/mL (Gla-300) in people with type 2 diabetes (T2DM) receiving basal-bolus insulin in a rEal-world setting.Materials and methodsParticipants were at least 18 years old, with T2DM for more than 1 year, HbA1c 7.0–10.0%. The primary endpoint was change in Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) total score (baseline to month 6). Secondary endpoints included reasons for starting Gla-300, changes in the DTSQ change version (DTSQc) total score, Hypoglycemia Fear Survey-II (HFS-II) total behavior and worry scores at months 6 and 12, HbA1c changes at months 3, 6, 9, and 12, and safety.ResultsMAGE included 87 adults (mean T2DM duration 17 years). The primary endpoint of DTSQs mean (standard deviation) total score improvement at month 6 was achieved (2.80 [5.46] points; p < 0.0001). The main reasons for Gla-300 initiation were to decrease HbA1c (89.7% of participants) and reduce the number of hypoglycemic events (35.6% of participants). Significant improvements were observed in the DTSQc total score and perceived hyperglycemia/hypoglycemia (baseline to month 6, p < 0.05). Significant changes in HFS-II behavior, worry, and total scores at 6 and 12 months were also observed (p < 0.05). There were no statistically significant changes in HbA1c. Safety outcomes, including hypoglycemia, were comparable to previously reported trials.ConclusionsThe MAGE study indicates that Gla-300, as part of a basal-bolus regimen, results in improved treatment satisfaction and reduced hypoglycemia fear in people with advanced T2DM.Electronic supplementary materialThe online version of this article (10.1007/s13300-020-00866-2) contains supplementary material, which is available to authorized users.

2192-PUB: Treatment Satisfaction in People with Type 2 Diabetes (T2D) Receiving Basal Insulin (BI): Results from Real-World Studies and Randomized Controlled Trials (RCTs) with Insulin Glargine 300 U/mL (Gla-300)

BI analogs can help optimize glycemic control in people with T2D, but the patients’ satisfaction is key for acceptance and treatment adherence. ACHIEVE, REACH, and REGAIN were open-label real-world studies comparing Gla-300 with standard of care BI (ACHIEVE: insulin glargine 100 U/mL [Gla-100] or insulin detemir [IDet]; REACH and REGAIN: Gla-100, IDet, insulin degludec [IDeg] or neutral protamine Hagedorn). EDITION 1-3 and BRIGHT were open-label RCTs comparing Gla-300 with Gla-100 and IDeg, respectively. All studies were in people with uncontrolled T2D and used the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs; Table). In RCTs and real-world studies, initiating BI in insulin-naïve participants was associated with improved treatment satisfaction after 6 months (ACHIEVE, 12 months) and a reduction in the perceived frequency of hyperglycemia. Perceived hypoglycemia increased slightly from low baseline values. Similar findings were found in patients switching BI, with improved patient satisfaction and reduced perceived frequency of hyperglycemia after 6 months of treatment, and no change in perceived hypoglycemia. Initiating or switching BI in people with uncontrolled T2D can improve patient satisfaction, irrespective of baseline diabetes treatment. Disclosure S.B. Harris: Advisory Panel; Self; Abbott, AstraZeneca, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck &amp; Co., Inc., Novo Nordisk Inc., Sanofi. Consultant; Self; Abbott, AstraZeneca, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck &amp; Co., Inc., Novo Nordisk Inc., Sanofi. Research Support; Self; AstraZeneca, Canadian Institutes of Health Research, Eli Lilly and Company, Health Canada/First Nations and Inuit Health Branch, Janssen Pharmaceuticals, Inc., JDRF, Lawson Foundation, Novo Nordisk Inc., Sanofi. Other Relationship; Self; AstraZeneca, Eli Lilly and Company, Novo Nordisk Inc., Sanofi. F.J. Snoek: Advisory Panel; Self; Abbott, Lilly Diabetes, Novo Nordisk A/S, Roche Diabetes Care. Research Support; Self; Sanofi. L. Meneghini: Advisory Panel; Self; Novo Nordisk Inc., Sanofi US. Consultant; Self; Applied Therapeutics, Sanofi US. F. Lauand: Employee; Self; Sanofi. J. Westerbacka: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. A. Roborel de Climens: Employee; Self; Sanofi. K. Khunti: Advisory Panel; Self; Amgen, AstraZeneca, Bayer AG, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Menarini Group, Merck Sharp &amp; Dohme Corp., Napp Pharmaceuticals, Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi-Aventis, Servier. Board Member; Self; AstraZeneca, Eli Lilly and Company, Merck Sharp &amp; Dohme Corp., Novo Nordisk A/S, Sanofi-Aventis. Consultant; Self; Amgen, AstraZeneca, Bayer AG, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Menarini Group, Merck Sharp &amp; Dohme Corp., Napp Pharmaceuticals, Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi-Aventis, Servier. Research Support; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp &amp; Dohme Corp., Novartis AG, Novo Nordisk A/S, Pfizer Inc., Sanofi-Aventis, Servier. Speaker’s Bureau; Self; Amgen, AstraZeneca, Bayer AG, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Menarini Group, Merck Sharp &amp; Dohme Corp., Napp Pharmaceuticals, Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi-Aventis, Servier. Funding Sanofi

Impact of Switching from Twice-Daily Basal Insulin to Once-Daily Insulin Glargine 300U/mL in People with Type1 Diabetes on Basal-Bolus Insulin: Phase4 OPTIMIZE Study.

IntroductionOPTIMIZE evaluated the efficacy, safety and treatment satisfaction of insulin glargine 300 U/mL once daily (Gla-300 OD) in people with type 1 diabetes mellitus (T1DM) previously uncontrolled on basal insulin twice daily (BID) as part of basal–bolus therapy.MethodsOPTIMIZE was a 28-week, prospective, interventional, single-arm phase 4 trial in adults with T1DM. At baseline, basal insulin BID treatment was switched to Gla-300 OD titrated to a fasting self-monitored blood glucose target of 4.4–7.2 mmol/L (80–130 mg/dL). The primary endpoint was the mean glycated haemoglobin (HbA1c) change from baseline to week 24. Secondary endpoints included self-monitored blood glucose, fasting-plasma glucose, hypoglycaemia and patient-reported outcomes including the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs).ResultsSwitching to Gla-300 OD significantly improved mean HbA1c (8.54% at baseline and 8.27% at week 24 [last observation carried forward, N = 94, p < 0.0001]; mean difference 0.27% [95% CI 0.15, 0.40]). There was a statistically significant decrease in fasting self-monitored blood glucose during the study (analysis of variance for repeated measures, p = 0.014; N = 72). Eight-point self-monitored blood glucose was significantly improved between baseline and week 24 for post-breakfast (p = 0.009), post-dinner (p = 0.009) and bedtime (p = 0.049) values. The study did not allow for any significant effects on confirmed and/or severe hypoglycaemia at the ≤ 3.9 mmol/L [≤ 70 mg/dL] or < 3.0 mmol/L [< 54 mg/dL] blood glucose cut-offs to be observed. Statistically significant improvements were observed in DTSQs total scores from baseline (24.1) to week 24 (29.4, p < 0.0001).ConclusionsA basal–bolus regimen including Gla-300 OD was associated with improvements in HbA1c and treatment satisfaction in people with uncontrolled T1DM previously receiving basal–bolus insulin including a basal insulin BID analogue.Trial RegistrationEudraCT number: 2015-001186-46.Electronic supplementary materialThe online version of this article (10.1007/s13300-019-00749-1) contains supplementary material, which is available to authorized users.

Cross-cultural validation of the Retinopathy Treatment Satisfaction Questionnaire status version (RetTSQs) in Serbian community: a cross-sectional study

ObjectiveCross-cultural translation and validation of the Serbian version of the Retinopathy Treatment Satisfaction Questionnaire status version (RetTSQs).DesignCross-sectional study.SettingsThe study was conducted between June 2017 and June 2018 at tertiary care...

Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in a Rapid-Initiation Model of Care for Human Immunodeficiency Virus Type 1 Infection: Primary Analysis of the DIAMOND Study.

BackgroundMost guidelines recommend rapid treatment initiation for patients with newly diagnosed human immunodeficiency virus type 1 (HIV-1) infection, but prospective US data are limited. The DIAMOND (NCT03227861) study using darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg is a phase 3 prospective study evaluating efficacy/safety of a single-tablet regimen in a rapid-initiation model of care.MethodsAdults aged ≥18 years began D/C/F/TAF ≤14 days from diagnosis without screening/baseline results; as results became available, participants not meeting predefined safety/resistance stopping rules continued. Primary endpoint was virologic response (HIV-1 RNA <50 copies/mL; intent-to-treat; US Food and Drug Administration [FDA] snapshot) at week 48; participant satisfaction was measured via the HIV Treatment Satisfaction Questionnaire status version (HIVTSQs).ResultsOf 109 participants, 87% were male, 32% black/African American, median (range) age was 28 (range, 19–66) years, 25% of participants had HIV-1 RNA ≥100 000 copies/mL, 21% had CD4+ cell count <200 cells/µL, and 31% enrolled ≤48 hours from diagnosis. At week 48, 97 (89%) participants completed the study and 92 (84%) achieved HIV-1 RNA <50 copies/mL (FDA snapshot). There were no protocol-defined virologic failures; incidences of adverse events (AEs) and adverse drug reactions (33%) were low, no serious AEs were study drug related, and 1 (<1%) participant discontinued due to study drug related AE(s). The overall HIVTSQs score at week 48 was 58 (maximum: 60).ConclusionsAt week 48, a high proportion of participants starting D/C/F/TAF achieved HIV-1 RNA <50 copies/mL and very few discontinued therapy. D/C/F/TAF was well tolerated, no participants discontinued due to baseline resistance stopping criteria, and high treatment satisfaction among participants was recorded.Clinical Trials RegistrationNCT03227861.

2327-PUB: Real-World Patient-Reported Outcomes (PROs) with Insulin Glargine 300 U/ml (Gla-300) in Basal Bolus-Treated People with Type 2 Diabetes (T2DM): The MAGE Study

Fear of hypoglycemia and treatment satisfaction both influence therapy adherence. MAGE was a 6-month multicenter, prospective, single-arm, observational study with a 6-month extension conducted in Belgium, mainly assessing patient satisfaction with Gla-300 in people ≥18 years, with T2DM for ≥1 year, HbA1c 7.0-10.0%, receiving a basal-bolus insulin regimen for ≥6 months ± oral antidiabetic therapy, and naïve to Gla-300. Primary objective: change of ≥2 points in Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) total score (TS) from baseline (BL) to month 6. Secondary objectives included change in: HbA1c, other DTSQs scores, and hypoglycemia fear scale II (HFS-II). The intent-to-treat population comprised 87 patients (Table). Primary endpoint was achieved; DTSQs TS increased by 2.80 (SD: 5.46; p&amp;lt;0.0001; Table). Significant decreases were seen in total HFS-II scores and worry/behavior subscales (all p&amp;lt;0.05). There was no change from BL in HbA1c (p&amp;gt;0.05); however, more patients reached HbA1c &amp;lt;7% at month 12 versus BL (11.5% vs. 0%). Hypoglycemia occurred at a mean (SD) 34.97 (48.28) events per patient-year. Treatment satisfaction and fear of hypoglycemia significantly improved after switching to Gla-300 in people with T2DM on basal-bolus insulin therapy in a real-life setting. Disclosure A.A. Verhaegen: Advisory Panel; Self; Amgen Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Lilly Diabetes, Merck &amp; Co., Inc., Sanofi. Speaker's Bureau; Self; Mylan, Novo Nordisk Inc. A. Scheen: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck Sharp &amp; Dohme, Novartis, Novo Nordisk, Sanofi, Servier. Research Support; Self; AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck Sharp &amp; Dohme, Novartis, Novo Nordisk, Sanofi, Servier. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck Sharp &amp; Dohme, Novartis, Novo Nordisk, Sanofi, Servier. K.C. Alexandre: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. J. Bruhwyler: Other Relationship; Self; Sanofi. I.M. Colin: None. Funding Sanofi

1020-P: Semaglutide-Induced Weight Loss Is Associated with Improved Health-Related Quality of Life and Treatment Satisfaction

Semaglutide, a glucagon-like peptide-1 analog for the once-weekly treatment of type 2 diabetes, provided superior glycemic control and weight loss (WL) vs. comparators in the SUSTAIN clinical trial program. This post hoc analysis assessed if WL was associated with patient-reported health-related quality of life (HRQoL) and treatment satisfaction improvements in SUSTAIN 2-5 and 7. Data for both semaglutide doses (0.5 and 1.0 mg) were pooled across trials (N=2,808). Change in HRQoL (Short Form-36 Health Survey version 2® [SF-36v2®] Physical Component Summary [PCS] and Mental Component Summary) and treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire status version) scores were evaluated in subjects who achieved ≥5% and ≥10% WL vs. those who did not at end of treatment (30, 40 or 56 weeks). Overall, 51.0% and 17.4% of subjects achieved ≥5% and ≥10% WL with semaglutide. Significantly greater improvements in the overall PCS score and most of its components were reported in subjects achieving ≥5% and ≥10% WL vs. those not achieving these responses (Table). WL responses also correlated with overall treatment satisfaction and perception of hyperglycemia (Table). In conclusion, semaglutide-induced WL was associated with improvements in PCS domains of the SF-36v2®, overall treatment satisfaction and perception of hyperglycemia across the SUSTAIN 2-5 and 7 trials. Disclosure K.T. Uusinarkaus: Advisory Panel; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Novo Nordisk Inc. Speaker's Bureau; Self; Amarin Corporation, Amgen Inc., Regeneron Pharmaceuticals, Sanofi US. Stock/Shareholder; Self; Abbott, AbbVie Inc., Amarin Corporation, Pfizer Inc. H.W. Rodbard: Advisory Panel; Self; Bayer US, Janssen Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., Merck &amp; Co., Inc., Novo Nordisk Inc., Sanofi. Consultant; Spouse/Partner; Eli Lilly and Company. Consultant; Self; Gan &amp; Lee Pharmaceuticals. Research Support; Self; Lexicon Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. Speaker's Bureau; Self; Merck &amp; Co., Inc., Novo Nordisk Inc. L. Van Gaal: Advisory Panel; Self; Janssen Pharmaceuticals, Inc., Johnson &amp; Johnson. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp &amp; Dohme Corp., Novo Nordisk A/S, Sanofi, Servier. J.P. Wilding: Consultant; Self; Astellas Pharma Europe Ltd., AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, NAPP Pharmaceuticals Limited, Novo Nordisk A/S, Sanofi. Research Support; Self; AstraZeneca, Novo Nordisk A/S. Speaker's Bureau; Self; Eli Lilly and Company, WebMD. T. Hansen: None. A. Sandberg: Employee; Self; Novo Nordisk A/S. S. Tadayon: Employee; Self; Novo Nordisk A/S. M.J. Davies: Advisory Panel; Self; Eli Lilly and Company, Janssen Global Services, LLC., Novo Nordisk A/S, Sanofi-Aventis, Servier. Research Support; Self; Boehringer Ingelheim International GmbH, Novo Nordisk Foundation. Speaker's Bureau; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk A/S, Sanofi-Aventis, Takeda Pharmaceutical Company Limited. Funding Novo Nordisk A/S

Improved treatment satisfaction in patients with type 1 diabetes treated with insulin glargine 100 U/mL versus neutral protamine Hagedorn insulin: An exploration of key predictors from two randomized controlled trials

AimInvestigate contributors to treatment satisfaction in type 1 diabetes (T1D). MethodsPost-hoc analysis using the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) in 771 T1D patients from two 28-week trials comparing once-daily insulin glargine 100U/mL (Gla-100) with once- or twice-daily NPH neutral protamine Hagedorn (NPH) insulin. ResultsGla-100 was associated with a significant improvement in treatment satisfaction versus NPH (overall population adjusted mean [standard error] DTSQs change from baseline: +1.13 [0.30] versus −0.04 [0.31]; p=0.006). In the overall population, treatment satisfaction improvement with all insulin regimens was related to less frequent severe hypoglycemia (coefficient−0.077; p=0.040) and HbA1c reduction (−0.066; p=0.082). By treatment regimen, relationships between treatment satisfaction and these outcomes approached or attained statistical significance for NPH insulin, but not Gla-100. In the overall population, predictors of treatment satisfaction improvement included: Gla-100 treatment (estimate 1.17, p=0.006), lower baseline DTSQs (−0.57, p<0.001), study (−1.01, p=0.019), lower severe hypoglycemia rate (0.17, p=0.012), and higher baseline HbA1c (0.44, p=0.014). By treatment regimen, these predictors remained significant for NPH insulin. ConclusionsGla-100 resulted in a significant improvement in treatment satisfaction versus NPH insulin, independent of baseline disease characteristics and clinical outcomes.

Effectiveness and Persistence with Liraglutide Among Patients with Type 2 Diabetes in Routine Clinical Practice—EVIDENCE: A Prospective, 2-Year Follow-Up, Observational, Post-Marketing Study

IntroductionThe aim of this study was to investigate whether the efficacy of liraglutide observed in randomized controlled trials translates into therapeutic benefits in the French population during routine clinical practice.MethodsThis observational, prospective, multicenter study included 3152 adults with type 2 diabetes who had recently started or were about to start liraglutide treatment. During 2 years of follow-up, an evaluation of the reasons for prescribing liraglutide, maintenance dose of liraglutide, changes in combined antidiabetic treatments, level of glycemic control, change in body weight and body mass index (BMI), patient satisfaction with diabetes treatment and safety of liraglutide were investigated. The primary study endpoint was the proportion of patients still receiving liraglutide and presenting with HbA1c <7.0% after 2 years of follow-up.ResultsAt the end of the study, 29.5% of patients maintained liraglutide treatment and reached the HbA1c target. Mean (±SD) HbA1c, fasting plasma glucose concentration, body weight and BMI were significantly reduced from baseline [8.46% (±1.46) to 7.44% (±1.20); 180 (±60) to 146 (±44) mg/dL; 95.2 (±20.0) to 91.1 (±19.6) kg; 34.0 (±7.2) to 32.5 (±6.9) kg/m2; respectively, all P < 0.0001]. Patient treatment satisfaction increased, with the mean diabetes treatment satisfaction questionnaire status version score increasing from 22.17 (±7.64) to 28.55 (±5.79), P < 0.0001. The main adverse event type was gastrointestinal, with a frequency of 10.9%, and the percentage of patients suffering ≥1 hypoglycemic episode decreased from 6.9% to 4.4%.ConclusionThe results of the EVIDENCE study suggest that the effectiveness of liraglutide in real-world clinical practice is similar to that observed in randomized controlled trials.FundingNovo Nordisk A/S.Trial RegistrationClinicalTrials.gov identifier, NCT01226966.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-015-0245-x) contains supplementary material, which is available to authorized users.

Treatment satisfaction in people with type 2 diabetes mellitus treated with once-weekly dulaglutide: data from the AWARD-1 and AWARD-3 clinical trials.

To compare treatment satisfaction among people with type 2 diabetes receiving dulaglutide 1.5 mg and dulaglutide 0.75 mg (a once-weekly, long-acting, glucagon-like peptide-1 receptor agonist) with those receiving either exenatide or placebo (AWARD-1 study) or metformin (AWARD-3 study) over 52 weeks. The Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) and change version (DTSQc) were used to evaluate total treatment satisfaction and perceived frequency of hyperglycaemia and hypoglycaemia. In the AWARD-1 study, significant improvements from baseline were observed in total DTSQs score for both dulaglutide doses (26 and 52 weeks) and exenatide (26 weeks). The improvement was significantly greater with both dulaglutide doses compared with placebo (26 weeks) and exenatide (26 and 52 weeks). The perceived frequency of hyperglycaemia was lower for all groups at 26 and 52 weeks compared with baseline. The improvement was greater with both dulaglutide doses and exenatide compared with placebo at 26 weeks, and was also greater with both dulaglutide doses compared with exenatide at 26 and 52 weeks. The exenatide group had an increase in perceived frequency of hypoglycaemia at 26 and 52 weeks. In the AWARD-3 study, significant improvements from baseline were observed for total DTSQs scores in all groups at 26 and 52 weeks. Perceived frequency of hyperglycaemia was lower for all groups at 26 and 52 weeks compared with baseline, and this improvement was greater with both dulaglutide doses compared with metformin at 52 weeks. Dulaglutide was associated with improvements in treatment satisfaction and a decrease in perceived frequency of hyperglycaemia.

Improved Treatment Satisfaction and Self-reported Health Status after Introduction of Basal-Supported Oral Therapy Using Insulin Glargine in Patients with Type 2 Diabetes: Sub-Analysis of ALOHA2 Study.

IntroductionThis study aimed to assess treatment satisfaction and self-reported health status in insulin-naïve patients with type 2 diabetes mellitus (T2DM) who started insulin glargine basal-supported oral therapy (BOT) with glycated hemoglobin (HbA1c) value of ≥6.5%, using data from Add-on Lantus® to Oral Hypoglycemic Agents 2 (ALOHA2) study, a 24-week single-arm, observational study of Japanese patients with T2DM, conducted as drug use surveillance in Japan.MethodsTreatment satisfaction was measured using the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) and change version (DTSQc) and self-reported health status using EuroQol 5 Dimension (EQ-5D). The results were compared between the groups stratified by HbA1c level at the final evaluation point: target-achieved (<7.0%) and target-not-achieved groups (≥7.0%).ResultsIn 1251 patients (336 in the target-achieved group), scores of DTSQs, DTSQc, and EQ-5D indicated significant improvement from baseline to the final evaluation point (both P < 0.01). The mean change in DTSQs scale score, DTSQs item score, and EQ-5D index score, and mean DTSQc scale score were significantly improved in the target-achieved group compared with the target-not-achieved group (P < 0.05 for all). DTSQs scale score and HbA1c level showed the same pattern of chronological change. Data analysis in patients stratified by DTSQs score showed better glycemic control in the high satisfaction group.ConclusionFollowing insulin glargine BOT introduction, treatment satisfaction and health status were improved from patients’ perspectives despite the need for daily injections. Based on the possible association between HbA1c 7.0% level achievement, treatment satisfaction, and health status, better glycemic control may be a key to successful treatment.Electronic supplementary materialThe online version of this article (doi:10.1007/s13300-015-0111-5) contains supplementary material, which is available to authorized users.

Self-care behaviour, treatment satisfaction and quality of life in people on intensive insulin treatment

The aim of this cross-sectional study was to identify self-care behaviours and their relationships with treatment satisfaction and quality of life in people attending a structured educational programme for patients on intensive insulin therapy. A sample of 104 people with diabetes (62 with type-1; 42 with type 2) was recruited from the National Institute of Endocrinology and Diabetology in Ľubochňa over six months. The majority of respondents were women (62.5%); had multiple daily injections of insulin (73%); diabetic late complications (68%) and had not previously participated in the structured educational programmes in the specialized diabetes centre (64.4%). Self-management behaviour data were collected by means of structured interviews with patients as well as during clinic visits. For measuring quality of life, the Audit Diabetes Dependent Quality of Life questionnaire and for measuring satisfaction with their treatment regimen, the Diabetes Treatment Satisfaction Questionnaire status version was used. General satisfaction with the treatment was significantly higher in people with diabetes, who implemented regular self-monitoring of the concentration of glucose in plasma (SMPG). We also demonstrated low adherence in the frequency of SMPG. 17% of respondents in our study performed daily SMPG. However, 52% respondents reported adaptation of insulin dosage in relation to factors such as carbohydrate intake, glycaemia values or degree of physical activity. Differences in quality of life due to performing the regular self-monitoring of glycaemia, adjustments of insulin doses in specific situations as well as carbohydrate counting were not significant. Performing the regular self-monitoring of glycaemia was associated only with higher treatment satisfaction. No significant improvement in quality of life was seen in people performing the regular self-monitoring of glycaemia, adjustments of insulin doses in specific situations or carbohydrate counting.

Quality of life and treatment satisfaction in the context of diabetes self‐management education

The aim of this study is to identify and compare factors affecting quality of life and treatment satisfaction in people attending the structured educational programme for patients with intensified insulin therapy. A sample of 104 patients was recruited from diabetes specialized centre between November 2006 and March 2007. For measure patient's quality of life, the Audit Diabetes Dependent Quality of Life questionnaire and for measure patient's satisfaction with their treatment regimen, the Diabetes Treatment Satisfaction Questionnaire status version was used. Treatment satisfaction has different variables or predictors from quality of life. Quality of life was affected by the number of reported diabetic late complications, type of insulin regimen, age and diabetes duration. Type of insulin regimen, the frequency of blood glucose self-monitoring and perceived frequency of hyperglycaemia demonstrated the significant association with treatment satisfaction. Our findings might help health-care professionals have a deeper understanding of the factors affecting quality of life and treatment satisfaction and thereby aid in the design of strategies to maintain or improve quality of life and treatment satisfaction.

Validation of the Revised 10-Item HIV Treatment Satisfaction Questionnaire Status Version and New Change Version

Objectives Previous validation of the HIV Treatment Satisfaction Questionnaire status version (HIVTSQs) found that nine of the 10 items performed well, but the demands item needed revision. This study investigated the psychometric properties of the revised HIVTSQs and new change version (HIVTSQc). Methods English-speaking Americans completed the HIVTSQs at baseline and Week 48 of a clinical trial of HIV treatments, and the HIVTSQc at Week 48. Demographic and viral load information was collected. Psychometric validation used item frequency distributions, Confirmatory Factor Analysis (CFA), item-total correlations, Cronbach's alpha, Spearman's rank correlation, Kruskal–Wallis and Mann–Whitney tests. Results At baseline, 126 of the 152 patients completed the HIVTSQs fully (100 of 106 at Week 48). The negatively skewed distribution of the revised demands item resembled that of the other nine, with comparable missing data. CFA (baseline and Week 48) supported the general satisfaction/clinical subscale (alpha 0.83; 0.85), lifestyle/ease subscale including demands (alpha 0.82; 0.85), and 10-item treatment satisfaction scale (alpha 0.89; 0.91). Subscale and scale scores differed significantly between ethnic groups. Viral load was not significantly related to subscale or scale scores. At Week 48, 97 of 106 patients completed the HIVTSQc fully. All items had negatively skewed distributions. CFA supported two subscales ( general satisfaction/clinical change alpha 0.85; lifestyle/ease change alpha 0.88) and 10-item treatment satisfaction change scale (alpha 0.92). Viral load change between baseline and Week 48 correlated significantly with patients' perceptions of change in HIV control ( control( c) item), but not with scale or subscale scores. Conclusion The excellent psychometric properties of the HIVTSQs and HIVTSQc support their use in clinical trials.