Diabetes Therapy-Related Quality Of Life Research Articles

Association between variation in hemoglobin A1c levels and diabetes therapy-related quality of life in patients with diabetes.

We aimed to investigate the association between glycemic variability and quality of life (QOL) in patients with diabetes, which has not been studied previously. Patients who were undergoing treatment at the Kyoto Prefectural University of Medicine Hospital and Kameoka City Hospital participated in the KAMOGAWA-DM study, and completed the diabetes therapy-related (DTR)-QOL questionnaire from January 2016 to July 2020 were included in this study. We used linear regression analyses to compare the association between DTR-QOL scores and glycemic variability. We included a total of 635 patients in this analysis. The hemoglobin A1c (HbA1c) levels of these patients were measured at least four times during the 9-month period, before and after answering the questionnaire. Results showed that HbA1c variability, HbA1c mean and duration of diabetes were negatively associated with the total DTR-QOL score. Conversely, the body mass index and total DTR-QOL score were positively associated with HbA1c variability. A small variation in HbA1c level was associated with higher total DTR-QOL scores and the scores for each factor. Reducing blood glucose variability is significant when we treat diabetes.

920-P: Effects of Hybrid Closed-Loop System on Glycemic Control and Psychological Aspects in Persons with Type 1 Diabetes Treated with Sensor-Augmented Pump—A Prospective Single-Center Observational Study

Introduction Since the Medtronic 770G hybrid closed-loop (HCL) system was approved in Japan in 2022, we evaluated the effects of the HCL system on glycemic control and psychological aspects in persons with type 1 diabetes mellitus (T1DM) treated with the Medtronic 640G predictive low glucose suspend (PLGS) system. Materials and Methods In a 3-month prospective observational study, 21 people with T1DM (mean age: 48.7 years; male: 5 people) treated with PLGS system were enrolled. The participants switched to the 770G system, where the algorithm maintains glucose levels at 120 mg/dl, and in 3 months the percentage of time in blood glucose range (TIR) 70-180 mg/dl and glycated hemoglobin level (HbA1c) were evaluated. Self-reported questionnaires were administered at baseline and in 3 months to assess their satisfaction, emotional distress, and quality of life (QoL), using Diabetes treatment satisfaction questionnaire status (DTSQs), Problem area in diabetes scale (PAID), and Diabetes therapy-related QoL (DTR-QoL), respectively. Results In 3 months, TIR increased from 63.2 ± 13.7% to 72.7 ± 11.1% (mean ± standard deviation) (P < 0.0005), whereas time above blood glucose range (TAR) 181-250 mg/dl decreased from 26.9 ± 9.1% to 19.7 ± 7.2 % (P < 0.0005). TAR > 250 mg/dl, time below blood glucose range (TBR) 54-69 mg/dl and TBR < 54 mg/dl did not differ significantly. HbA1c decreased from 7.7 ± 1.0% to 7.2 ± 0.8% (P = 0.0013). There were no significant changes in DTSQs, PAID, and DTR-QOL in 3 months (DTSQs 26.7 ± 6.0 compared with baseline 26.9 ± 4.0, P = 0.87, PAID 52.3 ± 17.9 compared with baseline 54.0 ± 16.3, P = 0.48, DTR-QoL 50.1 ± 19.0 compared with baseline 47.0 ± 16.9, P = 0.38). Conclusion HCL system could increase TIR, compared with PLGS system, without worsening treatment satisfaction, emotional distress, and QoL. This study suggested HCL system is useful for Japanese people with T1DM. Disclosure T. Akiyama: None. K. Orime: None. T. Yamakawa: None.

A cross-sectional study of the relationship between quality of life and sleep quality in Japanese patients with type 1 diabetes mellitus.

This study aimed to reveal the relationship between quality of life (QOL) and sleep quality in patients with type 1 diabetes mellitus (T1DM). Overall, 202 patients with T1DM were registered in our study, and 192 were eligible for analysis. Baseline characteristics and laboratory values were determined. Patients completed the Japanese versions of the Pittsburgh Sleep Quality Index (PSQI) and Diabetes Therapy-Related QOL (DTR-QOL) questionnaires. We investigated the relationship between the global PSQI and DTR-QOL total scores by using linear regression analysis. In univariate regression analysis, DTR-QOL total scores were associated with body mass index, alcohol consumption, hypertension, hemoglobin A1c (HbA1c), and global PSQI score (all p-value <0.05) but not with sleep duration. When the association between PSQI subscales and DTR-QOL total scores was examined, DTR-QOL total scores were significantly related to subjective sleep quality and daytime dysfunction. In a multivariate regression analysis, the global PSQI score was negatively related to DTR-QOL total scores. Patients with an HbA1c concentration ≥8.0% had significantly lower DTR-QOL total scores. We revealed a relationship between QOL and sleep quality in T1DM patients and showed that the relationship between QOL and PSQI subscales in T1DM patients may be different from that in patients with type 2 diabetes mellitus. Assessing and managing sleep quality may be necessary for patients with diabetes to improve QOL.

The Influence of Tofogliflozin on Treatment-Related Quality of Life in Patients with Type2 Diabetes Mellitus.

IntroductionTreatment-related quality of life (QOL) is an important aspect of diabetes management. We evaluated the influence of a sodium-glucose cotransporter 2 (SGLT2) inhibitor, tofogliflozin, on treatment-related QOL in Japanese patients with type 2 diabetes mellitus (T2DM).MethodsThis is the prespecified subanalysis study of the “Using TOfogliflozin for Possible better Intervention against Atherosclerosis for type 2 diabetes patients (UTOPIA)” trial. Treatment-related QOL was evaluated at baseline, week 26, week 52, and week 104 after the initiation of the study using the Diabetes Therapy-Related QOL questionnaire (DTR-QOL). Among the 340 patients in the original UTOPIA study, a total of 252 patients (127, tofogliflozin group; 125, conventional treatment group) who completed the DTR-QOL questionnaire at baseline were the study subjects of the current subanalysis.ResultsThe tofogliflozin and conventional treatment groups exhibited almost comparable baseline clinical characteristics, while the use of antihypertensive drugs and lipid-lowering agents was significantly lower in the tofogliflozin treatment group than in the conventional treatment group. Tofogliflozin treatment increased the total score of DTR-QOL7 from baseline (P < 0.001), while conventional treatment did not change it. There were statistically significant differences in delta change in the total DTR-QOL7 score and DTR-QOL7 Q4, Q5, Q6, and Q7 scores from the baseline to week 104 between the treatment groups. Delta changes in HbA1c (Spearman’s correlation coefficient, ρ = − 0.30, P < 0.001), fasting blood glucose (ρ = − 0.16, P = 0.031), BMI (ρ = − 0.19, P = 0.008), and waist circumference (ρ = − 0.17, P = 0.024) at week 104 were negatively associated with delta change in the total QOL7 score.ConclusionsOur data indicated that tofogliflozin treatment improved treatment-related QOL compared to conventional treatment in Japanese patients with T2DM, in accordance with the improvement of major cardiovascular risk factors.Trial registration: UMIN000017607Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-021-01125-8.

A Real-World, Prospective, Non-interventional Study of Adults with T2D Switching to IDegAsp from Glargine U100 or U300 in Japan.

IntroductionThis real-world study investigated glycaemic control and quality of life (QoL) in insulin-experienced Japanese patients with type 2 diabetes (T2D) who switched to insulin degludec/insulin aspart (IDegAsp).MethodsThis was a prospective, non-interventional, open-label, single-arm study. Eligible patients were adults (aged ≥ 20 years) with T2D, previously treated with insulin glargine 100 or 300 units/mL (glargine U100/U300) with or without prandial insulin, who switched to IDegAsp as part of routine practice. Change from baseline to end of study (EOS; 26 weeks after initiation or IDegAsp discontinuation) in the following endpoints was assessed by adjusted mixed models for repeated measures: glycated haemoglobin (HbA1c; primary endpoint), fasting plasma glucose (FPG), insulin dose and total Diabetes Therapy-Related Quality of Life (DTR-QoL) score. Non-severe hypoglycaemia was assessed in the 4-week period prior to initiating IDegAsp and in the 4-week period before EOS or discontinuation using negative binomial regression.ResultsThe full analysis set included 236 patients from 29 centres in Japan with mean (± SD) age 63.2 years (± 12.3), HbA1c 7.7% (± 1.0) and diabetes duration 14.9 (± 9.3) years. After 26 weeks with IDegAsp, HbA1c (estimated change − 0.1% [− 0.2; 0.0]95% confidence interval (CI), p = 0.3036) and FPG (− 7.5 mg/dL [− 23.5; 8.5]95% CI, p = 0.3477) were maintained; there were significant reductions in basal and total insulin dose: estimated change of − 3.4 units/day [− 3.8; − 3.0]95% CI and − 1.0 units/day [− 1.9; − 0.1]95% CI, respectively (both p < 0.05). Non-severe hypoglycaemia rates were similar in the periods before and after initiating IDegAsp, while there was a significant improvement in total DTR-QoL score after 26 weeks with IDegAsp (p = 0.0012).ConclusionThese real-world data suggest that switching to IDegAsp from glargine U100 or U300 was well tolerated in a Japanese population with T2D, with no new safety or tolerability signals, and associated with maintenance of glycaemic control and improved QoL.Trial registrationThis study is registered at ClinicalTrials.gov: NCT03745157.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-021-01117-8.

Effect of Orally Administered Semaglutide Versus Dulaglutide on Diabetes-Related Quality of Life in Japanese Patients with Type2 Diabetes: The PIONEER10 Randomized, Active-Controlled Trial.

IntroductionIn the randomized Peptide InnOvatioN for Early diabEtes tReatment (PIONEER) 10 trial, once-daily orally administered semaglutide—the first oral glucagon-like peptide 1 receptor agonist (GLP-1RA)—was similarly tolerated with comparable (at 7 mg) or better (at 14 mg) efficacy versus the injectable GLP-1RA dulaglutide 0.75 mg. Health-related quality of life (HRQoL) in PIONEER 10 was assessed using the Japanese-specific Diabetes Therapy-Related Quality of Life (DTR-QoL) questionnaire.MethodsThe DTR-QoL comprises 29 questions, providing four domain and total scores. Answers were converted to a score between 0 and 100, with higher scores indicating greater HRQoL. Two estimands were prespecified: treatment policy (regardless of treatment discontinuation or rescue medication use) and trial product (assuming on treatment without rescue medication) in all randomized patients. Outcomes were assessed at weeks 26 and 52.ResultsMean baseline DTR-QoL domain scores were similar between treatment arms and were generally lower (giving more scope for improvement) for “anxiety and dissatisfaction with treatment” (62.1–65.3) and “satisfaction with treatment” (53.9–57.9) than “burden on social activities and daily activities” (76.5–77.7) and “hypoglycemia” (83.5–88.2). Using the treatment policy estimand, orally administered semaglutide 7 and 14 mg improved HRQoL versus dulaglutide 0.75 mg for the total score (estimated mean change from baseline [CfB] 7.3 and 8.1 vs 3.3; estimated treatment difference [ETD] 3.9 and 4.8) and the “anxiety and dissatisfaction with treatment” domain (CfB 9.7 and 10.9 vs 3.7; ETD 6.0 and 7.2) at week 52. Orally administered semaglutide 14 mg improved the “satisfaction with treatment” domain versus dulaglutide 0.75 mg (CFB 13.8 vs 5.7; ETD 8.1). DTR-QoL scores for orally administered semaglutide tended to be more durable (sustained over time) than for dulaglutide. Outcomes for the trial product estimand were similar.ConclusionOrally administered semaglutide 7 and 14 mg improved the patients’ HRQoL measured by the Japanese-specific DTR-QoL instrument versus dulaglutide 0.75 mg at week 52.Trial registrationClinicalTrials.gov NCT03015220.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-020-00985-w.

Patient Satisfaction and Clinical Efficacy of Flash Glucose Monitoring in Patients with Type 1 Diabetes: A Prospective, Single-Center, Single-Arm Study.

IntroductionFrequent self-monitoring of blood glucose (SMBG) is usually required in patients with type 1 diabetes (T1D). However, the fear of self-testing, hygiene, and social obstacles may deter some patients from SMBG. Flash glucose monitoring (FGM), a less-invasive glucose monitoring method, was launched in Japan in September 2017. The aim of this study was to evaluate patient satisfaction and the clinical efficacy of FGM in Japanese patients with T1D.MethodsPatient satisfaction with FGM was assessed using the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and Diabetes Therapy-Related Quality of Life (DTR-QOL) questionnaire before (baseline) and 4 and 12 weeks after initiating FGM use in 20 Japanese patients with T1D. Clinical parameters related to glucose metabolism, such as glycated hemoglobin (HbA1c) levels, were assessed, and glucose fluctuations were evaluated using the FGM data. Values at 4 and 12 weeks after initiating FGM were compared with baseline data using the Wilcoxon signed-rank test. The mean absolute relative difference (MARD) between glucose values detected using the FGM device and by SMBG was also calculated.ResultsThe DTSQ scores significantly improved 12 weeks after initiating FGM (P < 0.001). The DTR-QOL scores related to “burden in social activities” and “treatment satisfaction” also significantly improved 12 weeks after initiating FGM (P = 0.024 and 0.007, respectively). The HbA1c values and the percentage of time within the target glucose range (3.9–7.8 mmol/L) at the 12-week time point also improved, from 58 ± 5 (baseline) to 54 ± 4 mmol/mol (P = 0.002) and from 36% (interquartile range [IQR] 25–44.5%) (baseline) to 43% (IQR 39–50%) (P = 0.016), respectively. The MARD between glucose values detected using FGM and those detected using SMBG was 12.2% throughout the study period.ConclusionsFlash glucose monitoring contributed to improved patient satisfaction and the adjustment of blood glucose levels in patients with T1D.Trial RegistrationUniversity Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR): UMIN000029673Electronic Supplementary MaterialThe online version of this article (10.1007/s13300-020-00859-1) contains supplementary material, which is available to authorized users.

Randomized Multicenter Evaluation of Quality of Life and Treatment Satisfaction in Type 2 Diabetes Patients Receiving Once-Weekly Trelagliptin Versus a Daily Dipeptidyl Peptidase-4 Inhibitor

IntroductionDipeptidyl peptidase-4 (DPP-4) inhibitors are an established treatment in type 2 diabetes mellitus (T2DM). The objective of this study was to investigate differences in quality of life (QOL) and treatment satisfaction among treatment-naïve T2DM patients receiving once-weekly trelagliptin or a daily DPP-4 inhibitor.MethodsIn this multicenter, randomized, open-label, parallel-group, phase IV study conducted in Japan, 218 patients were randomized to trelagliptin 100 mg once weekly or a once- or twice-daily DPP-4 inhibitor for 12 weeks (NCT03014479; JapicCTI-173482). QOL and treatment satisfaction were assessed using the Diabetes Therapy-Related QOL (DTR-QOL) Questionnaire and Diabetes Treatment Satisfaction Questionnaire (DTSQ), respectively. The primary endpoint was change from baseline in DTR-QOL total score at week 12. Secondary endpoints included further analysis of the DTR-QOL and DTSQ components. Other endpoints included glycemic control, treatment adherence, and safety.ResultsThe between-group difference in the change from baseline to week 12 in DTR-QOL total score was 2.418 (95% confidence interval − 1.546, 6.382; P = 0.2305). Analysis of the DTR-QOL and DTSQ results by subscales and stratification generally showed a numerical improvement with trelagliptin over daily DPP-4 inhibitors. QOL and treatment satisfaction improved with a reduction in frequency of concurrent and study drug dosing. Treatment adherence was > 97% for both groups. The effect of trelagliptin on glycemic control was similar to that seen with daily DPP-4 inhibitors. Trelagliptin and daily DPP-4 inhibitors were well-tolerated and demonstrated similar safety profiles.ConclusionsOnce-weekly trelagliptin 100 mg administered for 12 weeks resulted in a numerically, but not statistically, greater improvement in QOL and treatment satisfaction versus daily DPP-4 inhibitors. The decision to administer once-weekly or daily DPP-4 inhibitor treatment is likely to depend on patient preferences and the treatment policies of physicians.Trial RegistrationClinicalTrials.gov (NCT03014479) and JAPIC (JapicCTI-173482).FundingTakeda Pharmaceutical Company Ltd.Electronic Supplementary MaterialThe online version of this article (10.1007/s13300-019-0643-1) contains supplementary material, which is available to authorized users.

The Effect of Linagliptin versus Metformin Treatment-Related Quality of Life in Patients with Type 2 Diabetes Mellitus.

IntroductionThere have been no studies directly comparing the effect of dipeptidyl peptidase-4 inhibitors with that of metformin on treatment-related quality of life (QOL) when used as first-line therapy in patients with type 2 diabetes mellitus (T2DM).MethodsThis study is a prospective, randomized, open-label, multicenter, parallel-group, comparative study. Forty-four participants who failed to achieve target glycemic control with diet and exercise therapy were randomly allocated to receive linagliptin or metformin therapy. We compared treatment-related QOL among the two groups using the Oral Hypoglycemic Agent Questionnaire, version 2 (OHA-Q version 2) and the self-administered Diabetes Therapy-Related QOL (DTR-QOL) questionnaire.ResultsAfter randomization, 21 patients in the linagliptin group and 22 patients in the metformin treatment group were included in the full analysis set. Biochemical parameters, incidence of adverse effects, and rate of adherence to medication were comparable between the two groups. Over the 24-week treatment period, no significant differences in overall OHA-Q scores between the groups were observed, although the subscale 1 (treatment convenience) score was significantly higher in the linagliptin group than in the metformin group. The overall DTR-QOL score did not differ between the two groups; however, the DTR-QOL scores significantly improved after 24 weeks of linagliptin treatment, but not after metformin treatment.ConclusionWe did not find significantly better treatment-related QOL with linagliptin among Japanese patients with T2DM. In terms of treatment convenience, our data showed that linagliptin was superior to metformin.FundingThis study was financially supported by Nippon Boehringer Ingelheim Co., Ltd. and Eli Lilly and Company. The journal’s article processing fees were covered by a research fund from Juntendo University.Clinical Trial RegistrationUMIN000022953.Electronic Supplementary MaterialThe online version of this article (10.1007/s13300-018-0539-5) contains supplementary material, which is available to authorized users.

Effect of the Combination Therapy of Liraglutide, a GLP-1 Receptor Analog, and IDegAsp in Patients with Type 2 Diabetes

Background: Diabetes care management aims to not only achieve good glycemic control but also maintain the quality of life (QoL). Basal insulin-treated patients frequently receive bolus insulin as a strengthening therapy; however, concerns exist about QoL due to the increasing number of injections. We examined the glycemic effect and QoL in patients treated with liraglutide (Lira) and insulin degludec/insulin aspart (IDegAsp). Methods: Patients with type 2 diabetes treated with basal-supported oral therapy (BOT) and DPP-4 inhibitor were enrolled in this observational study. Basal insulin was switched to IDegAsp at the same dose and DPP-4 inhibitor to Lira simultaneously; no titration protocol was used. We estimated the clinical and laboratory parameters and assessed the change in QoL within 12 weeks using the diabetes therapy-related QoL (DTR-QoL) questionnaire. The timing of dose up in regard to IDegAsp and Lira was also determined. Results: Fourteen patients were enrolled (male/female: 9/5, age (years): 63.6). The IDegAsp dose ranged from 9.1 to 13.7 U; all patients received 0.9 mg/day of Lira. The combination therapy significantly decreased HbA1c levels (8.7% vs. 7.1%, P=0.02), pre-breakfast glucose level (138.2 mg/dL vs. 108.9 mg/dL, P=0.044), bodyweight (62.9 kg vs. 60.3 kg, P=0.003), and BMI (24.6 vs. 23.5, P=0.004). The total DTR-QoL score at baseline was 61.6 and significantly improved to 73.2 (P=0.004). Significant improvement was also seen in D3 score (hypoglycemia; 63.6 vs. 81.4, P=0.036). D4 score (satisfaction with treatment) showed an increasing trend (59.0 vs. 78.2) and was negatively correlated with HbA1c levels (P=0.049). Conclusion: The change from BOT to the combination therapy of Lira and IDegAsp significantly improved glycemic control and reduced the bodyweight without deteriorating QoL in type 2 diabetes, although the treatment modality changed from one-injection to two-injection therapy. Disclosure M. Harada: None. M. Shinoda: None. R. Sakamoto: None. J. Suzuki: None. K. Takahashi: None. T. Yamakawa: None.

Study Protocol for the Initial Choice of DPP-4 Inhibitor in Japanese Patients with Type 2 diabetes Mellitus: Effect of Linagliptin on QOL (INTEL-QOL) Trial.

IntroductionConsideration of treatment-related quality of life (QOL) is important in diabetes management. However, no studies have compared the influence of dipeptidyl peptidase-4 inhibitors versus metformin on treatment-related QOL when used as first-line therapy in patients with type 2 diabetes mellitus.MethodsThis study is a prospective, randomized, open-label, multicenter, parallel-group, comparative study. Between June 2016 and December 2017, 44 participants who failed to achieve glycemic control despite diet and exercise therapy were recruited at 14 clinics and randomly allocated to linagliptin or metformin therapy. Treatment-related QOL was assessed with the Oral Hypoglycemic Agent Questionnaire, version 2 (OHA-Q ver. 2) and the self-administered Diabetes Therapy-Related QOL (DTR-QOL) questionnaire. The primary study outcome is the difference in total OHA-Q ver. 2 score between the two treatment groups at the end of the study. The secondary outcomes include differences in the scores for each OHA-Q ver. 2 subscale between the two treatment groups at the end of the study, change in total DTR-QOL score and for each domain from baseline to the end of treatment, changes in glycemic control, and adverse events.Planned outcomeThe present study is designed to assess the effects of linagliptin on the treatment-related QOL. Results will be available in the near future. Study findings are expected to provide useful information on how to maintain or improve QOL in patients with type 2 diabetes mellitus treated with insulin.FundingNippon Boehringer Ingelheim Co., Ltd. and Eli Lilly and Company.Clinical trial registrationUMIN000022953.

New Medications for the Treatment of Diabetes.

New Medications for the Treatment of Diabetes.

Effects of linagliptin versus voglibose on treatment-related quality of life in patients with type 2 diabetes: sub-analysis of the L-STEP study.

Treatment-related quality of life (QOL) is an important aspect of diabetes management. However, no studies have compared the influence of dipeptidyl peptidase-4 inhibitors versus alpha-glucosidase inhibitors on treatment-related QOL. This prespecified sub-analysis of the Linagliptin Study of Effects on Postprandial blood glucose (L-STEP) compared the effects of linagliptin (5 mg once daily) and voglibose (0.2 mg/meal thrice daily) on treatment-related QOL in Japanese patients with type 2 diabetes (T2DM) inadequately controlled with diet and exercise therapy. Among 366 subjects in the original study, 182 in the linagliptin group and 173 in the voglibose group were included in this analysis. The outcome of this study was change in QOL as assessed by the Diabetes Therapy-Related Quality of Life 17 (DTR-QOL17) questionnaire from baseline to week 12. Compared with baseline data, total DTR-QOL17 scores were significantly higher after 12 weeks of linagliptin and voglibose treatment. The change in the total DTR-QOL17 score and the score of one domain, burden on social activities and daily activities, was significantly greater in the linagliptin group than in the voglibose group. In addition, only linagliptin treatment was identified as a factor associated with an increased total DTR-QOL17 score. Linagliptin is superior to voglibose in terms of improving treatment-related QOL in Japanese patients with T2DM.

Association of diabetes therapy-related quality of life and physical activity levels in patients with type 2 diabetes receiving medication therapy: the Diabetes Distress and Care Registry at Tenri (DDCRT 17).

To examine the association between diabetes therapy-related quality of life (DTR-QOL) and physical activity levels, and identify factors associated with high diabetes therapy-related quality of life. Cross-sectional data from 2970 patients with type 2 diabetes in a Japanese diabetes registry were assessed for independent correlations between DTR-QOL (domains 1-4) and high physical activity levels. Data collected by the International Physical Activity Questionnaire were analyzed by logistic regression and adjusted for potential confounders. The mean patient age, BMI and HbA1c level were 65.8years, 24.7kg/m2 and 7.6% (58.7mmol/mol), respectively. Univariate analysis showed that DTR-QOL domain 1, 2 and 4 scores were significantly associated with physical activity levels (p=0.0046, p=0.0004 and p<0.001, respectively, but domain 3 score was not (p=0.5073). In a multivariable-adjusted logistic regression model, odds ratios (ORs) of DTR-QOL domains 1, 3 and 4 were independently associated with high physical activity (ORs for 2nd to 4th quartile and p for trend; [domain 1] 1.16, 1.56, 1.22, p=0.032; [domain 3] 1.45, 1.55, 1.38, p=0.049; [domain 4] 1.09, 1.30, 1.51, p=0.001, respectively), but domain 2 was not (ORs for 2nd to 4th quartile and p for trend; 1.19, 1.26, 1.23, p=0.096). High diabetes therapy-related QOL scores were associated with high levels of physical activity in patients with type 2 diabetes. Because this is a cross-sectional study, further study is needed to evaluate the causal association between therapy-related QOL and physical activity.

The effects of non-surgical periodontal treatment on glycemic control, oxidative stress balance and quality of life in patients with type 2 diabetes: A randomized clinical trial.

AimThe purpose of this study was to investigate the effects of non-surgical periodontal treatment on hemoglobinA1c (HbA1c) levels, oxidative stress balance and quality of life (QOL) in patients with type 2 diabetes mellitus (T2DM) compared to no periodontal treatment (simple oral hygiene instructions only).MethodsThe design was a 6-month, single-masked, single center, randomized clinical trial. Patients had both T2DM and chronic periodontitis. Forty participants were enrolled between April 2014 and March 2016 at the Nephrology, Diabetology and Endocrinology Department of Okayama University Hospital. The periodontal treatment group (n = 20) received non-surgical periodontal therapy, including scaling and root planing plus oral hygiene instructions, and consecutive supportive periodontal therapy at 3 and 6 months. The control group (n = 17) received only oral hygiene instructions without treatment during the experimental period. The primary study outcome was the change in HbA1c levels from baseline to 3 months. Secondary outcomes included changes in oxidative stress balance (Oxidative-INDEX), the Diabetes Therapy-Related QOL and clinical periodontal parameters from baseline to 3 months and baseline to 6 months.ResultsChanges in HbA1c in the periodontal treatment group were not significantly different with those in the control group at 3 and 6 months. Systemic oxidative stress balance and QOL significantly improved in the periodontal treatment group compared to the control group at 3 months. In the subgroup analysis (moderately poor control of diabetes), the decrease in HbA1c levels in the periodontal treatment group was greater than that in the control group at 3 months but not significant.ConclusionsIn T2DM patients, non-surgical periodontal treatment improved systemic oxidative stress balance and QOL, but did not decrease HbA1c levels at 3 months follow-up.Trial registrationCurrent Controlled Trials UMIN-ICDR UMIN 000013278 (Registered April 1, 2014).

Satisfaction and efficacy of switching from daily dipeptidyl peptidase-4 inhibitors to weekly trelagliptin in patients with type 2 diabetes-Randomized controlled study.

We compared treatment satisfaction between daily dipeptidyl peptidase-4 (DPP-4) inhibitors and a weekly DPP-4 inhibitor in patients with type 2 diabetes. The study was a 12-week, open-label, randomized, multicenter, controlled trial. Participants were Japanese patients with type 2 diabetes who had received daily DPP-4 inhibitors for more than 3 months. Patients were randomly assigned to a treatment cohort: (1) a group that continued taking daily DPP-4 inhibitors (daily group); or (2) a group that switched from daily DPP-4 inhibitors to a weekly DPP-4 inhibitor, trelagliptin (weekly group). The primary outcome was the change in treatment satisfaction levels from baseline to 12 weeks between the two groups, according to Diabetes Treatment Satisfaction Questionnaire (DTSQ) and Diabetes Therapy-Related Quality of Life (DTR-QOL) questionnaire scores. The changes in glycemic control and body weight were also assessed. Of 49 patients initially enrolled in the study, 47 completed the study. The change in DTSQ scores in the weekly group was not significantly different from that in the daily group. However, the improvements in total score and subscale domains 1 and 2 in the DTR-QOL analysis, which relate to burden on social/daily activities and anxiety/dissatisfaction with treatment, were significantly greater in the weekly group than the daily group (p = 0.048, 0.013 and 0.045, respectively). Mean changes in glycated hemoglobin levels and body weight were comparable between the groups. Switching from daily DPP-4 inhibitors to a weekly DPP-4 inhibitor, trelagliptin, could partially improve treatment satisfaction levels in patients with type 2 diabetes without affecting glycemic control.

The Influence of Sitagliptin on Treatment-Related Quality of Life in Patients with Type 2 Diabetes Mellitus Receiving Insulin Treatment: A Prespecified Sub-Analysis

IntroductionTreatment-related quality of life (QOL) is an important aspect of diabetes management. Here, we investigated the influence of sitagliptin, a dipeptidyl peptidase-4 inhibitor, on treatment-related QOL in patients with type 2 diabetes mellitus treated with insulin.MethodsThis was a prespecified sub-analysis of the Sitagliptin Preventive Study of Intima-Media Thickness Evaluation (SPIKE). The study population consisted of 71 subjects in the sitagliptin group, and 62 subjects in the conventional group who were treated with insulin. Patients of the sitagliptin group were started on sitagliptin in addition to ongoing insulin therapy. In the conventional group, either increasing the dose of current insulin therapy or the addition of oral hypoglycemic agents other than dipeptidyl peptidase-4 inhibitors was allowed to achieve glycemic control. Treatment-related QOL was evaluated before and 104 weeks after the initiation of the study using the Diabetes Therapy-Related QOL Questionnaire 7 (DTR-QOL7).ResultsForty-five out of 71 subjects in the sitagliptin group and 41 out of 62 subjects in the conventional group filled out the QOL questionnaire at week 104. The DTR-QOL7 score at week 104 was significantly increased from baseline in the sitagliptin group, while that in the conventional group was not changed. However, the changes in score did not differ between the two groups. Change in HbA1c was negatively associated with change in score.ConclusionsOur data suggest that sitagliptin added to insulin treatment was comparable to other treatments in terms of its impact on treatment-related QOL.Clinical Trial RegistrationClinicalTrials.gov identifier: UMIN000007396.FundingMitsubishi Tanabe Pharma Co., Ono Pharmaceutical Co., and Novo Nordisk.

Efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes receiving conventional therapy: clinical implication of the importance of exercise habits during treatment with ipragliflozin.

To evaluate the efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes mellitus and inadequate glycemic control and investigate the impact of maintaining exercise habits during treatment. A total of 20 patients were enrolled. Patients aged 20-70years with type 2 diabetes mellitus were administered 50mg of ipragliflozin once daily for 12weeks. The primary endpoint was the change in glycated hemoglobin levels from baseline to week 12. Key secondary endpoints included changes in total body weight, body composition, serum lipid levels, and diabetes therapy-related quality of life from baseline to week 12. Adverse events were recorded throughout the study. The patients' glycated hemoglobin levels were 0.69% lower at week 12 versus baseline (adjusted mean difference from baseline; P<0.01, n=18). Mean total body weight, body composition, and serum lipid levels also improved significantly from baseline. Of note, stratification analysis by physical activity level revealed slight but significant reductions in skeletal muscle mass and muscle mass, but not body fat mass, in the minimal exercise group compared to the data for the moderate exercise group. One of the subdomain structures in diabetes therapy-related quality of life questionnaire, "Anxiety and dissatisfaction with treatment," was significantly improved. Although no major hypoglycemic episodes occurred, two adverse events were reported. Daily treatment with ipragliflozin was associated with marked improvements in glycemic control and body composition without major side effects, and this improvement was affected by exercise habits. This study was registered with UMIN CTR (no. UMIN000014388).

Improvement of quality of life through glycemic control by liraglutide, a GLP-1 analog, in insulin-naive patients with type 2 diabetes mellitus: the PAGE1 study

BackgroundIn addition to achieving good glycemic control, diabetes care management aims to improve the quality of life (QOL) in patients. Treatment-associated difficulties and side effects frequently cause deterioration in QOL. Liraglutide, a GLP-1 receptor agonist, is a novel injection drug that promotes insulin secretion. It is a user-friendly, once-daily injection with fewer hypoglycemic events. In this study, we aimed to examine the effect of liraglutide therapy on QOL in patients.MethodsIn total, 304 insulin- and liraglutide-naïve patients with type 2 diabetes were enrolled in this observational study; they received liraglutide therapy for 12 weeks. The main outcome measure was change in QOL from baseline, which was assessed using diabetes therapy-related QOL (DTR-QOL).ResultsAt week 12, liraglutide significantly decreased HbA1c levels (8.7 ± 1.5 vs. 7.5 ± 1.3, p < 0.001) and BMI (27.9 ± 5.3 vs. 27.3 ± 5.2, p < 0.001). According to the QOL scores, although the treatment modality had changed from non-injection to injection therapy, liraglutide improved patient satisfaction with treatment. Significant correlations were found between change in HbA1c level and satisfaction with treatment, as well as between change in body weight and burden on social and daily activities, anxiety and dissatisfaction with treatment, and hypoglycemia.ConclusionsLiraglutide significantly improved glycemic control and reduced the body weight without deteriorating QOL in obese patients with type 2 diabetes.Trial registration UMIN-CTR: UMIN000007159

Effect of switching basal insulin regimen to degludec on quality of life in Japanese patients with type 1 and type 2 diabetes mellitus.

BackgroundMaintainance of a stable basal insulin level is important for glycemic control in treatment of diabetes mellitus. Recently introduced insulin degludec has the longest duration of action among basal insulin formulations. The purpose of this study was to assess changes in quality of life (QOL) associated with switching the basal insulin regimen to degludec in patients with type 1 and type 2 diabetes mellitus.MethodsThis 24-week open-label intervention study included type 1 (n = 10) and type 2 (n = 20) diabetes mellitus patients, with adequately controlled hemoglobin A1c (HbA1c), who had received insulin glargine or detemir for at least 6 months. The primary outcome was change of QOL from baseline, as assessed by the Diabetes Therapy-Related QOL (DTR-QOL) application, after switching from glargine or detemir to degludec. HbA1c and other parameters were also assessed as secondary outcomes.ResultsQOL and HbA1c in patients with type 1 diabetes mellitus were unchanged during this study. In patients with type 2 diabetes mellitus, HbA1c did not change, but total DTR-QOL score was significantly improved from baseline after switching to degludec. The DTR-QOL Factor 2, “Anxiety and dissatisfaction with treatment”, was significantly improved in patients with type 2 diabetes mellitus and especially in the subgroup receiving basal supported oral therapy (BOT).ConclusionsSwitching of the basal insulin regimen from glargine or detemir to degludec significantly improved the QOL of patients with type 2 diabetes mellitus who were receiving BOT, by reducing mental stress or anxiety about their treatment.