Although randomized controlled trials have demonstrated the efficacy of real-time continuous glucose monitoring (rtCGM), evidence from routine clinical practice remains limited, particularly in Asian populations. This study aimed to evaluate the effectiveness and safety of rtCGM initiation in individuals with diabetes. This multicenter, single-arm, retrospective, observational study was conducted at 34 sites across Japan (Clinical trial registration: UMIN000054275). Adults ≥18 years of age with diabetes who began using the Dexcom G6 rtCGM system, had a baseline glycated hemoglobin (HbA1c) level ≥7.5%, and continued rtCGM for at least 26 weeks were included. Factors associated with changes in HbA1c levels were examined using multivariate linear regression models. Among 192 participants, the mean HbA1c levels at 26 weeks were significantly lower (8.62 ± 1.14% vs. 7.88 ± 1.16%, p < 0.001) than those at baseline, with a difference of -0.73 ± 1.03%. In the multivariate analysis, greater HbA1c reduction was independently associated with higher baseline HbA1c (β = -0.40; p < 0.001), longer CGM active time (β = -0.008; p = 0.043), and older age (β = -0.010; p = 0.012), whereas prior isCGM use was associated with smaller reductions (β = +0.28; p = 0.045). Sex was also independently associated with changes in HbA1c levels (p = 0.028). During the 26-week follow-up period, one patient (0.5%) experienced diabetic ketoacidosis and four individuals (2.1%) experienced severe hypoglycemia. rtCGM initiation was associated with significantly lower HbA1c levels after 26 weeks of rtCGM use. These findings support the efficacy and safety of the Dexcom G6 in routine clinical practice.
ABSTRACT Aims/Introduction Sarcopenic obesity, defined by reduced muscle mass and strength with excess adiposity, is poorly characterized in Japanese individuals with type 2 diabetes (T2D). This post hoc analysis assessed its prevalence and associations with physical quality of life (QOL), walking ability, and falls. Materials and Methods This post hoc cross‐sectional analysis used sub‐cohort data from the Impact of Diabetes Mellitus on Dynapenia (iDIAMOND) study, conducted across seven medical centers. The study included 930 individuals aged 40–75 years (527 with T2D and 403 without diabetes [non‐D]). Sarcopenia was diagnosed using the Asian Working Group for Sarcopenia criteria, defined as low grip strength and/or slow gait speed with low skeletal muscle mass index. Sarcopenic obesity was diagnosed using the Japanese Working Group on Sarcopenic Obesity criteria, defined as high body mass index (BMI) or waist circumference combined with low grip strength, low skeletal muscle mass relative to BMI, and high body fat percentage. Participants meeting neither criterion were classified as robust. Results Among participants aged 40–75 years, sarcopenic obesity was observed in 4.9% of those with T2D and 0.5% of non‐D individuals (P < 0.001). In the T2D group, sarcopenic obesity was associated with lower physical QOL, reduced physical activity, slow gait speed, and a high incidence of falls compared with the robust group. Multivariate logistic regression identified advanced age, high BMI, and reduced physical activity as independent correlates of sarcopenic obesity. Conclusions Sarcopenic obesity is more prevalent in individuals with T2D and is associated with impaired physical QOL, reduced walking ability, and increased falls.
Background/Objectives: Visit-to-visit glycated hemoglobin A1c (HbA1c) variability is associated with cardiovascular diseases (CVDs) and all-cause mortality, independent of mean HbA1c levels. Metabolic dysfunction-associated steatotic liver disease (MASLD) is associated with CVDs and mortality. We aimed to clarify the association between annual HbA1c variability and MASLD development in individuals with type 2 diabetes (T2D). Methods: A retrospective cohort study was conducted in 402 Japanese patients (219 men, 183 women) with T2D. The participants' HbA1c levels were measured every 2 months, and their HbA1c coefficient of variation (HbA1c-CV) was calculated from the HbA1c in the past year. We statistically evaluated the association between HbA1c-CV and noninvasive clinical indices of MASLD, including the hepatic steatosis index (HSI), fibrosis-4 (FIB-4) index, aspartate aminotransferase-to-platelet ratio index (APRI), and non-alcoholic fatty liver disease fibrosis score (NFS). Results: Multiple regression analysis of clinical variables and each MASLD index showed that all liver fibrosis indices, including the FIB-4 index (p < 0.001), APRI (p = 0.005), and NFS (p < 0.001), were positively correlated with HbA1c-CV, whereas the HSI was not (p = 0.148). These associations remained even after adjusting for the medications used in the participants. Conclusions: The development of liver fibrosis, estimated using noninvasive blood biochemical indices, is independently and positively associated with annual HbA1c-CV in individuals with T2D. This result suggests that a comprehensive approach, including early MASLD risk stratification, may be beneficial for optimal diabetes management.
BACKGROUND:The ISCHIA study demonstrated that intermittently scanned continuous glucose monitoring (isCGM) combined with structured education effectively reduced the time below range (TBR) in individuals with type 1 diabetes. Given that the influence of sex on CGM metrics has remained unclear, we performed a post hoc analysis of the ISCHIA study to evaluate the impact of isCGM together with structured education on TBR and other parameters in men and women separately. METHODS:Data for 93 individuals who completed the ISCHIA study were analyzed. Baseline characteristics and intervention outcomes, including CGM indices and quality of life (QOL) scores, were stratified by sex for comparative analysis. RESULTS:Age, body mass index, disease duration, and insulin dosage at baseline did not differ significantly between men and women. Intervention outcomes including TBR (9.9±6.2% vs 10.3±7.6% for men vs women, respectively), time in range (61.5±11.2% vs 59.7±10.9%), and time above range (28.6±12.7% vs 30.0±13.4%) as well as QOL scores also did not show any significant sex differences. CONCLUSION:The use of isCGM together with structured education was suggested to be effective in reducing TBR among individuals with type 1 diabetes regardless of sex. J. Med. Invest. 73 : 74-79, February, 2026.
ABSTRACTAims/IntroductionThis study examined the effects of high‐intensity interval walking training (IWT) compared to moderate‐intensity continuous walking training (CWT) on muscle strength, walking ability, and health‐related quality of life (QOL) in people with diabetes accompanied by lower extremity weakness.Materials and MethodsPeople with diabetes accompanied by low isometric knee extensor strength using a simple manual dynamometer (n = 50) were screened and randomly divided into 2 groups: CWT (n = 25) and IWT (n = 25). Both groups were instructed by a physical therapist to perform walking training with the goal of 120 min/week over a 5‐month period. The primary outcome, mean change of isometric knee extensor strength, and secondary outcomes, such as gait speed and health‐related QOL, were measured at baseline and the end of the intervention.ResultsAt the end of the intervention, there was no significant difference in the degree of change in isometric knee extension strength between the two groups. However, there was a significant increase in changes in gait speed and physical QOL in the IWT group (gait speed, P < 0.01; physical QOL, P < 0.05).ConclusionsThe present study showed that IWT for people with diabetes accompanied by lower extremity weakness did not improve knee extension muscle strength compared to CWT but did improve walking ability and physical QOL.
Oxidative stress and inflammation contribute to diabetes-related organ damage beyond hyperglycemia. Imeglimin and sodium-glucose cotransporter 2 inhibitors may modulate redox balance through distinct mitochondrial pathways, but their comparative effects on organ-level stress remain unclear. To compare the effects of imeglimin and empagliflozin on oxidative stress, inflammation, and subclinical organ stress markers in type 2 diabetes mellitus (T2DM). In this 24-week, prospective, randomized, open-label study, people with T2DM received imeglimin (n = 34) or empagliflozin (n = 42). Changes in urinary 8-hydroxy-2′-deoxyguanosine (u8-OHdG) and liver-type fatty acid-binding protein (L-FABP) were assessed as co-primary endpoints. Secondary endpoints included serum diacron-reactive oxygen metabolites (d-ROM), biological antioxidant potential (BAP), serum 8-OHdG (s8-OHdG), tumor necrosis factor receptors 1/2 (TNFR1/2), and organ stress markers: N-terminal pro-brain natriuretic peptide (NT-proBNP), Fibrosis-4 index (FIB-4), and cardio-ankle vascular index (CAVI). u8-OHdG levels increased significantly, while L-FABP levels were not significantly changed at 24 weeks, suggesting a systemic rather than renal oxidative response. Only empagliflozin improved FIB-4, NT-proBNP, and CAVI values. Both treatments reduced TNFR1/2 values and increased BAP values. In the empagliflozin group, univariate analysis showed that ΔFIB-4 was positively correlated with ΔTNFR1 and ΔTNFR2, while ΔNT-proBNP and ΔCAVI showed inverse trends with ΔBAP. Multivariate analysis identified changes in hemoglobin A1c and Δd-ROM as independent predictors of FIB-4 improvement, and empagliflozin use as an independent predictor of ΔCAVI. Both agents induced antioxidant and anti-inflammatory responses. In addition, empagliflozin improved cardiac, hepatic, and vascular stress markers, possibly through its antioxidant and anti-inflammatory effects. Japan Registry of Clinical Trials (registration number jRCT1061230069, date of registration October 24, 2023).
AIMS/INTRODUCTION:Red blood cell distribution width (RDW) is a parameter of erythrocyte volume heterogeneity that has been traditionally used as an indicator of anemia and other hematopoietic abnormalities. Although the RDW-coefficient of variation (RDW-CV) increases in individuals with diabetes, its clinical significance in diabetic kidney disease (DKD), including glomerular and tubular injury, is unclear. Therefore, we aimed to clarify the relationship between RDW-CV and DKD indices in individuals with type 2 diabetes. MATERIALS AND METHODS:This was a multicenter, retrospective, cross-sectional study. In 490 Japanese individuals with type 2 diabetes (309 men and 181 women), multiple regression analysis was performed to examine the degree of association between DKD indices (estimated glomerular filtration rate (eGFR), urinary albumin-to-creatinine ratio (uACR), log-transformed uACR (Log-uACR), urinary liver-type fatty acid-binding protein (uL-FABP)-to-creatinine ratio (uL-FABPCR), and log-transformed uL-FABPCR (Log-uL-FABPCR)) and clinical confounding factors, including RDW-CV. RESULTS:No significant associations were identified between RDW-CV and eGFR, uACR, or Log-uACR in either the simple or multiple linear regression analyses. However, significant and independent positive associations between RDW-CV and both uL-FABPCR and Log-uL-FABPCR were identified in multiple regression analyses (P = 0.002 and P = 0.034, respectively). Additionally, logistic regression analysis showed that RDW-CV was an aggravating factor for the incidence of advanced tubular injury [odds ratio, 1.241 (95% confidence interval: 1.010-1.520), P = 0.037]. CONCLUSIONS:RDW-CV was independently and positively correlated with urinary excretion of L-FABP. Therefore, RDW-CV may be a simple and useful biomarker for detecting renal tubular injury in individuals with type 2 diabetes.
Diabetic foot ulcers are a leading cause of lower extremity amputations, significantly affecting the quality of life. Excessive plantar surface pressure and shear stress are key factors in ulcer development and aggravation. This study aimed to determine the association of these forces with the progression of diabetic peripheral neuropathy to help in foot-ulcer treatment and prevention. Participants were categorized into four groups: individuals with no diabetes (NS), people with diabetes without peripheral neuropathy or foot-ulcer history (DM), those with diabetes with peripheral neuropathy but no foot-ulcer history (DPN), and people with diabetes with active or past foot ulcers (DFU). Plantar pressure and shear stress were measured during walking. The study included 47 participants. The DFU group demonstrated significantly higher pressure peak value and plantar pressure time integral value at the fifth metatarsal head compared to the DPN and DM groups. The DPN group exhibited significantly higher shear-stress time integral and shear stress time compared to the NS group. In the DPN group, an increase in shear stress was observed. In the DFU group, an increase in plantar pressure and a tendency for an increase in shear stress were noted. Further research is needed to understand how these changes trigger the onset of foot ulcers.
Prevention of diabetic retinopathy is important to keep vision and quality of life. To examine the effects of an intensive multifactorial intervention and hypoglycemia on retinopathy in people with type 2 diabetes. J-DOIT3 (Japan Diabetes Optimal Integrated Treatment Study for 3 Major Risk Factors of Cardiovascular Diseases) is a multicenter, open-label, parallel-group randomized clinical trial that examined the efficacy of an intensified multifactorial intervention on cardiovascular outcomes and mortality in people with type 2 diabetes aged 45 to 69 years with hypertension and/or dyslipidemia. The study was conducted at 81 sites in Japan from June 2006 to March 2009, and data analysis was performed from September 2018 to August 2025. Participants were randomly assigned to intensive therapy for glucose, blood pressure, and lipids or conventional therapy and were followed up for a median duration of 8.5 years. This study is a secondary analysis of retinopathy events of the secondary outcomes, composed of onset of retinopathy, progression of retinopathy, and loss of vision likely due to retinopathy. Among 2540 total participants (5080 eyes) randomly assigned to intensive therapy or conventional therapy, mean (SD) age was 59.0 (6.3) years, and 965 participants (38.0%) were female. Intensive therapy was associated with a risk reduction in onset of retinopathy (hazard ratio [HR], 0.83; 95% CI, 0.70-0.98; P = .03) but not with progression of retinopathy (HR, 1.02; 95% CI, 0.70-1.49; P = .93). Hemoglobin A 1 c (HbA 1 c ) at 1 year after randomization was associated with onset (HR, 1.31; 95% CI, 1.13-1.51; P < .001), even after adjustment for baseline risk factors (ie, lower body mass index, longer duration of diabetes, higher fasting plasma glucose, higher blood pressure, and comorbid nephropathy), with no clear HbA 1 c threshold observed. Moreover, compared with those without a hypoglycemic episode during the intervention, the risk of onset was higher in those with 0.5 hypoglycemic episodes per year or fewer (HR, 1.25; 95% CI, 1.02-1.53) and even higher in those with more than 1 hypoglycemic episode per year (HR, 1.85; 95% CI, 1.39-2.47). This secondary analysis of the J-DOIT3 randomized clinical trial shows that in a randomized clinical trial setting, higher HbA 1 c and nonsevere hypoglycemia are associated with higher risk of onset of retinopathy in people with type 2 diabetes, even when good glycemic management, with a very low incidence of severe hypoglycemia, is achieved, suggesting the importance of strict glycemic management without any hypoglycemia. ClinicalTrials.gov Identifier: NCT00300976
AIMS/INTRODUCTION:Obesity triggers various health disorders, but information on these disorders in real-world settings remains limited. To address this knowledge gap, we developed a database directly linked to electronic medical records (EMRs). We here present the baseline data for this database, designated Japan Obesity Research Based on electronIc healTh Records (J-ORBIT). MATERIALS AND METHODS:Individuals with obesity disease diagnosed according to the criteria of the Japan Society for the Study of Obesity were registered in J-ORBIT from seven medical centers in Japan. We analyzed the relationship between body mass index (BMI), clinical characteristics, and the prevalence of obesity-related health disorders in this cohort. RESULTS:Data were obtained from 1,169 individuals, with a mean (±SD) age of 56.9 ± 15.3 years and a BMI of 31.4 ± 6.1 kg/m2. The prevalence of health disorders varied substantially across BMI categories, with a higher BMI being associated with an increased prevalence of hyperuricemia or gout, obstructive sleep apnea syndrome or obesity hypoventilation syndrome, musculoskeletal disorders, and obesity-related kidney disease, as well as with a higher frequency of both a family history of obesity and of a history of childhood obesity. Among individuals with a BMI of ≥25 kg/m2, the prevalence of hypertension and dyslipidemia did not increase with BMI, whereas that of glucose intolerance decreased with increasing BMI. CONCLUSIONS:The J-ORBIT system, which collects clinical data in real time directly from EMRs, has the potential to provide insight into obesity and its associated health conditions, thereby contributing to improved care of affected individuals.
Background: The relationship between the percent coefficient of variation (%CV) and the risk of severe hypoglycemia (SH) or non-severe hypoglycemia (NSH) in patients with type 1 diabetes (T1D) remains to be elucidated. Materials and Methods: The Effect of Intermittent-Scanning Continuous Glucose Monitoring to Glycemic Control Including Hypoglycemia and Quality of Life of Patients with Type 1 Diabetes Mellitus (ISCHIA) study was a crossover, randomized, controlled trial for hypoglycemia prevention in patients with T1D using multiple daily injections (MDIs). Blinded continuous glucose monitoring (CGM) data of 93 patients obtained during the Control period (84 days) were used for the post hoc analysis. The receiver operating characteristics (ROC) curves were analyzed to determine the discrimination thresholds of %CV corresponding to the low blood glucose index (LBGI) > 5 and LBGI ≥ 2.5, and the occurrence of SH. Results: The %CV corresponding to LBGI > 5 and LBGI ≥ 2.5 was 42.2% and 37.0%, respectively. The episodes of SH were observed in three patients, and the %CV corresponding to the occurrence of SH was 40.7%. Conclusions: The identification of the discrimination threshold of %CV associated with the risk of SH or NSH in patients with T1D is needed.
Background: Metabolic dysfunction-associated steatotic liver disease (MASLD) causes progressive liver fibrosis. Although erythrocyte mean corpuscular volume (MCV) has been shown to have a positive correlation with all-cause mortality, the association between MCV and the development of MASLD has not been fully elucidated. Here, we examined the clinical significance of the association between MCV and MASLD. Methods: A cross-sectional study was carried out in 1009 Japanese individuals (including 186 individuals aged < 60 years and 823 individuals aged ≥ 60 years) with metabolic disorders. The relationships between MCV and noninvasive clinical markers of liver fibrosis, including fibrosis-4 (FIB-4) index, aspartate aminotransferase-to-platelet ratio index (APRI), and non-alcoholic fatty liver disease (NAFLD) fibrosis score (NFS), were statistically evaluated. Results: Using multiple and logistic regression analyses in overall subjects, it was found that MCV was positively and independently associated with the values of FIB-4 index, APRI, NFS, and the prevalence of liver fibrosis defined by each index. However, the associations between the MCV value and MASLD indices were found to be positive in subjects aged ≥ 60 years but not in those aged < 60 years. Conclusions: MCV might be a simple and useful biomarker for the development of MASLD in the elderly.
Background : FreeStyle Libre uses the algorithm to calculate the sensor glucose (SG) levels. The manufacturer announced that they had changed the algorithm from the first generation (Gen. 1) to the third gener- ation (Gen. 3). To assess the difference, we conducted an observational study to analyze the characteristics of the measurements by these two algorithms compared to the capillary blood glucose (BG) levels. Methods : Participants with type 1 diabetes wore two FreeStyle Libre sensors, one on the left arm used with Gen. 3 algo- rithm, and another on the right arm used in combination with the FreeStyle Libre Reader with Gen. 1 algorithm. Results : Data were collected from 11 participants. The Bland-Altman analysis of the measurements by Gen. 3 algorithm showed bias of 7.4 mg / dl and no proportional bias was observed (r = 0.130). In contrast, the Bland-Altman analysis of the measurements by Gen. 1 algorithm showed bias of 4.4 mg / dl and proportional bias was observed (r = 0.424). The MARD of Gen. 3 algorithm and Gen. 1 algorithm was 11.9 +/- 9.0% and 9.7 +/- 8.3%, respectively (P = 0.053). Conclusion : No proportional bias in the measurements by Gen. 3 algorithm was observed, but in those by Gen. 1 algorithm. J. Med. Invest. 71 : 225-231, August, 2024
Background: Rebound hyperglycemia may occur following glucagon treatment for severe hypoglycemia. We assessed rebound hyperglycemia occurrence after nasal glucagon (NG) or injectable glucagon (IG) administration in patients with type 1 diabetes (T1D) and type 2 diabetes (T2D). Methods: This was a pooled analysis of 3 multicenter, randomized, open-label studies (NCT03339453, NCT03421379, NCT01994746) in patients >= 18 years with T1D or T2D with induced hypoglycemia. Proportions of patients achieving treatment success [blood glucose (BG) increase to >= 70 mg/dL or increase of >= 20 mg/dL from nadir within 15 and 30 minutes]; BG >= 70 mg/dL within 15 minutes; in-range BG (70-180 mg/dL) 1 to 2 and 1 to 4 hours postdose; and BG >180 mg/dL 1 to 2 and 1 to 4 hours postdose were compared. Incremental area under curve (iAUC) of BG >180 mg/dL and area under curve (AUC) of observed BG values postdose were analyzed. Safety was assessed in all studies. Results Higher proportions of patients had in-range BG with NG vs IG (1-2 hours: P = .0047; 1-4 hours: P = .0034). Lower proportions of patients had at least 1 BG value >180 mg/dL with NG vs IG (1-2 hours: P = .0034; 1-4 hours: P = .0068). iAUC and AUC were lower with NG vs IG (P = .025 and P < .0001). As expected, similar proportions of patients receiving NG or IG achieved treatment success at 15 and 30 minutes (97-100%). Most patients had BG >= 70 mg/dL within 15 minutes (93-96%). The safety profile was consistent with previous studies. Conclusion: This study demonstrated lower rebound hyperglycemia risk after NG treatment compared with IG.
Although patients with hyperuricemia and gout often have dyslipidemia, the effects of febuxostat, a xanthine oxidase inhibitor, on their lipid profiles are unclear. Thus, we performed a sub-analysis of the randomized PRIZE study in which the effects of febuxostat on carotid atherosclerosis were investigated in patients with hyperuricemia. The participants were randomized to the febuxostat or control group. The primary endpoint of this sub-analysis was changes in the patients’ non-high-density lipoprotein cholesterol (HDL-C) levels from baseline to 6-month follow-up. Correlations between the changes in lipid profiles and cardiometabolic parameters were also evaluated. In total, 456 patients were included. From baseline to 6 months, non-HDL-C levels were significantly reduced in the febuxostat group (−5.9 mg/dL, 95% confidence interval [CI]: −9.1 to −2.8 mg/dL, p < 0.001), but not in the control group (−1.3 mg/dL, 95% CI: −4.4 to 1.8, p = 0.348). The reduction in non-HDL-C levels was more pronounced in women and correlated with changes in serum uric acid and estimated glomerular filtration rate levels only in the febuxostat group. In patients with hyperuricemia, febuxostat treatment was associated with reduced non-HDL-C levels from baseline to the 6-month follow-up compared to the control treatment, suggesting that the lipid-lowering effect of febuxostat should be considered when targeting dyslipidemia.
The real-world SPARTA Japan study confirmed the effectiveness and safety of the fixed-ratio combination of insulin glargine 100 U/mL plus lixisenatide (iGlarLixi) once daily over 6 months in Japanese people with type 2 diabetes (T2D). This post hoc analysis examined the impact of participant characteristics on the achievement of age-defined glycaemic targets with iGlarLixi therapy. The retrospective, observational SPARTA Japan study included adults with T2D who initiated iGlarLixi. In this analysis, data from insulin-naïve and insulin-experienced participants were separately assessed to compare glycated haemoglobin (HbA1c), body weight and safety outcomes between those who achieved (‘achieved’ group) and those who did not achieve (‘not-achieved’ group) age-defined glycaemic targets after 6 months of iGlarLixi. The not-achieved group was further stratified by whether or not their iGlarLixi dose was increased during treatment. In total, 418 participants were included in this analysis (138 insulin naïve and 280 insulin experienced). Among both insulin-naïve and insulin-experienced participants, those in the achieved group were older and had lower baseline HbA1c than those in the not-achieved group. Compared with the not-achieved group, the achieved group showed significantly greater HbA1c reductions from baseline (in both insulin-naïve and insulin-experienced participants) and significantly greater body weight reductions (in insulin-naïve participants), despite some participants in the not-achieved group receiving significantly higher insulin glargine doses than those in the achieved group. In both insulin-naïve and insulin-experienced participants, the incidence of hypoglycaemia and gastrointestinal-related adverse events was similar in the achieved and not-achieved groups. In a multivariate analysis, glycaemic target achievement was significantly more likely in older individuals and those who lost weight during iGlarLixi treatment. Achievement of age-defined glycaemic targets with iGlarLixi treatment for 6 months was significantly affected by increased age and body weight loss, regardless of prior insulin exposure. UMIN-CTR Trials Registry, UMIN000044126; registered 10 May 2021. iGlarLixi is an injectable product used to treat type 2 diabetes that contains a fixed combination of two drugs, insulin glargine (at a concentration of 100 U/mL) and lixisenatide. The SPARTA Japan study investigated the effectiveness of controlling blood glucose levels and the safety of iGlarLixi in Japanese people when taken once daily for over 6 months as part of their routine medical care. The analysis reported in this article looked back at data from SPARTA Japan to assess whether certain characteristics of the people who took part in the study affected how well blood glucose targets were met. People who had previously taken insulin and those who had not were identified, and their results were assessed separately. The people were divided into those who had met their blood glucose level target (with the target defined as the glycated haemoglobin level for each person based on their age) and those who had not met their target. It was found that people who achieved their blood glucose target while receiving iGlarLixi were more likely to be older, to have had a lower glycated haemoglobin level before starting iGlarLixi, and to have lost weight during treatment than those who did not achieve their target, whether or not they had previously been treated with insulin. Side effects of excessively low blood glucose levels or gastrointestinal upset with iGlarLixi treatment occurred in a similar number of people who achieved or did not achieve their blood glucose target.
This study examined the non-inferior efficacy of telenutrition education compared with face-to-face nutrition education in managing glycemic control in people with type 2 diabetes mellitus (T2DM). Participants had T2DM and a glycated hemoglobin (HbA1c) ranged 6.5–9.5%. Thirty participants were randomly assigned to either the telenutrition or face-to-face nutrition education group. During the 32-week intervention period, the participants received four sessions on nutrition education from a registered dietitian at the hospital. The telenutrition group received remote education via a videoconferencing platform. Face-to-face nutrition education was conducted using paper-based instructions. The main outcome measure was the non-inferiority of HbA1c levels in the telenutrition group compared to the face-to-face nutrition group. The non-inferiority of telenutrition education was considered valid if the intergroup difference in the mean values of the change in HbA1c had a bilateral 95% confidence interval (CI) upper limit below 0.40%. The intergroup difference in the mean HbA1c change from baseline to the fourth nutrition education session was −0.11 (95% CI −0.54–0.32) for both groups. The upper limit of the bilateral 95% CI was 0.32%, which was below the 0.40% non-inferiority margin (non-inferiority test; p = 0.011). Telenutrition education was not inferior to face-to-face nutrition education for glycemic management in people with T2DM.
ObjectiveThis study aimed to identify the amount of weight loss needed in patients with obesity to improve metabolic syndrome (MetS), a risk factor for cardiovascular disease (CVD), over a long period of time.MethodsA total of 576 patients with obesity were enrolled in this study. Effects of continuous physician-supervised weight loss on the cumulative MetS components excluding abdominal circumference (defined as obesity-related CVD risk score) were investigated during a 5-year follow-up period. The extent of weight loss required to reduce the obesity-related CVD risk components was assessed using receiver operating characteristic (ROC) curve analyses.ResultsOf the 576 participants, 266 completed 5-year follow-up, with 39.1% and 24.1% of them achieving ≥5.0% and ≥7.5% weight loss at the 5-year follow-up, respectively. The area under the ROC curve for reducing the obesity-related CVD risk components was 0.719 [0.662–0.777] at 1 year and 0.694 [0.613–0.775] at 5 years. The optimal cut-off value for weight loss was 5.0% (0.66 sensitivity and 0.69 specificity) and the value with 0.80 specificity was 7.5% (0.45 sensitivity) at 5 years. Greater reductions in weight were associated with greater improvements in the obesity-related CVD risk score at all follow-up periods (P-trend <0.001). Obesity-related CVD risk score was significantly improved by 5.0–7.5% and ≥7.5% weight loss at 1 year (P = 0.029 and P < 0.001, respectively) and ≥7.5% weight loss at 5 years (P = 0.034).ConclusionsA weight loss of ≥5.0% at 1 year and ≥7.5% at 5 years could reduce the number of obesity-related CVD risk components in patients with obesity.