Diabetes Treatment Satisfaction Research Articles

PIONEER REAL Italy: Real-World Usage of Once-Daily Oral Semaglutide in Adults with Type 2 Diabetes.

The PIONEER REAL Italy study examined the clinical outcomes associated with oral semaglutide in real-world settings. This was a multicenter, prospective, non-interventional, single-arm study in adults with type 2 diabetes (T2D) who were treatment-naive to injectable glucose-lowering medications. Participants initiated oral semaglutide at doses of 3, 7, or 14mg, and were followed for 34-44weeks. The primary endpoint was the change in glycated hemoglobin (HbA1c) from baseline to the end of study (EoS). Secondary endpoints were the change in body weight (BW), the percentage of participants attaining HbA1c < 7%, composite endpoints of HbA1c reduction ≥ 1%-point plus BW reduction (≥ 3%/ ≥ 5%), and treatment satisfaction measured using Diabetes Treatment Satisfaction Questionnaires (DTSQ) status. Safety was assessed in participants who received ≥ 1 dose of oral semaglutide. Of 445 eligible participants, 398 completed the study; 351 (78.9%) remained on oral semaglutide at EoS. The median time of treatment follow-up was 40weeks for each participant. At baseline, participants had a mean (standard deviation [SD]) age of 62.9 (10.2) years, HbA1c of 7.8% (1.3), T2D duration of 8.0 (6.9) years, and BW of 87.8 (19.0) kg. The estimated changes (95% confidence interval) from baseline to EoS in HbA1c and BW were -0.9%-points (-1.01 to -0.82; p < 0.0001) and -3.8kg (-4.45 to -3.24; p < 0.0001), respectively. At EoS, 65.1% achieved HbA1c < 7%; 25.5% and 19.1% reached HbA1c reduction ≥ 1%-point plus ≥ 3% and ≥ 5% reduction in BW, respectively. DTSQ status improved significantly at EoS (estimated change + 5.24; 95% CI, 5.24 to 6.61, p < 0.0001). Of participants who remained on oral semaglutide at EoS, 72.6% received a 7-mg dose. No new safety signals were observed. In Italy, the real-world clinical outcomes associated with oral semaglutide in adults with T2D complemented the findings from clinical trials. This reassures oral semaglutide usage in routine clinical practice. NCT05230615.

Improved glycaemic control in people with type 2 diabetes initiating or switching to IDegAsp in a real-world setting in China.

To investigate glycaemic control in Chinese adults with type 2 diabetes (T2D) initiating, or switching to insulin degludec/insulin aspart (IDegAsp), a co-formulation of basal, and bolus insulin, in a real-world setting. A 20-week, prospective, single-arm, open-label, non-interventional study was conducted in Chinese adults with T2D initiating, or switching to IDegAsp after anti-hyperglycaemic treatment with oral antidiabetic drugs (OADs), other insulins, or glucagon-like peptide-1 receptor agonists. The primary endpoint was a change in HbA1c from baseline to end of the study; the secondary endpoints included a change in fasting plasma glucose and Diabetes Treatment Satisfaction Questionnaire (DTSQ) score. Significant reductions were observed in mean HbA1c and fasting plasma glucose, among both the overall population (N = 878; -1.27%-points [95% CI: -1.36; -1.19]; p < 0.0001, and -1.61 mmol/L [95% CI: -1.81; -1.41]; p < 0.0001, respectively), and in subgroups switching from OADs only, or basal, or premix insulins ± OADs. The mean total DTSQ score increased from 26.4 (baseline) to 31.6 (end-of-study). No significant, or unexpected tolerability, or safety issues were observed. Significant reductions were observed in incidence rates of non-severe (rate ratio 0.37 [95% CI: 0.24; 0.59]; p < 0.0001) and nocturnal non-severe (rate ratio 0.45 [95% CI: 0.21; 0.94]; p = 0.0326) hypoglycaemic episodes. In a broad, real-world Chinese population of adults with T2D, initiating or switching to IDegAsp was associated with improved glycaemic control and lower rates of hypoglycaemia. The use of IDegAsp could be an effective treatment option for those with suboptimal glycaemic control or therapeutic inertia.

Disease Awareness in Patients With Type 2 Diabetes: Analysis of Baseline Data From the SMART-Finder Observational Study.

Chronic kidney disease (CKD) is a common comorbidity of type 2 diabetes mellitus (T2DM). Data on the determination of CKD-related biomarkers among patients with T2DM in a real-life setting within Germany are limited. We aimed to determine the prevalence of CKD and risk factors, availability of urine albumin-to-creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR) values, treatment satisfaction, and quality of life among patients with T2DM in Germany. SMART-Finder is a retrospective and prospective, observational, digital, patient-centered cohort study being performed as part of the routine use of an adherence-supporting app. This baseline analysis' observation period was from August to November 2023. Patients with T2DM in Germany who actively used the MyTherapy app; allowed push notifications; and documented use of diabetes medications, renin-angiotensin system inhibitors, finerenone, and/or blood glucose test strips were eligible for inclusion. Study materials (background information, electronic consent form, and laboratory and electronic questionnaires) were provided to eligible patients via app push notifications. Participants completed an electronic case report form that included questions on their blood pressure; their most recent UACR, eGFR, and glycated hemoglobin (HbA1c) values in the past 12 months; the EQ-5D-5L; and the Diabetes Treatment Satisfaction Questionnaire. The primary outcome was the proportion of patients with a UACR of ≥30 mg/g. Of 9527 invited eligible patients, 101 completed the electronic case report form (male: n=61; female: n=40; age: mean 54.2, SD 11.4 y). Of these, 1 female patient and 5 male patients reported their UACR values; 3 (all male) had a UACR of ≥30 mg/g. The remaining 95 patients reported that their health care professionals had not provided UACR measurements. Only 9 (8.9%) patients were aware of their latest eGFR values (3 patients: 15-44 mL/min/1.73 m2; 6 patients: 45-89 mL/min/1.73 m2), 90 provided HbA1c values (80 patients: ≥6.0%), 46 had a systolic blood pressure of ≥130 mm Hg, and 83 reported former or current nephrotoxic medication intake. The mean EQ-5D-5L index score was 0.7 (SD 0.3; range -0.1 to 1.0; 50 patients). The mean Diabetes Treatment Satisfaction Questionnaire score was 28.8 (SD 6.8; range 9.0-36.0; 49 patients). Patients with T2DM who were using an adherence-supporting app in Germany lacked awareness of CKD-related biomarkers but had high knowledge of self-manageable biomarkers (eg, blood pressure, serum fasting glucose, and HbA1c values). Our results suggest that treating physicians either do not test for UACRs and eGFRs or do not inform patients about the results. Nonadherence to diagnostic testing guidelines and a lack of physician-patient communication put patients at risk. Another reason for this health literacy imbalance may be the focus on HbA1c instead of kidney comorbidity in patient education material. Future goals for diabetes management must include guideline-compliant testing of CKD-related biomarkers and open physician-patient communication.

One-year real-world benefits of Tandem Control-IQ technology on glucose management and person-reported outcomes in adults with type 1 diabetes: a prospective observational cohort study.

This multicentre prospective observational cohort study aimed to evaluate real-world changes in glycaemic and person-reported outcomes after 1 year's use of Control-IQ technology in adults with type 1 diabetes. Adults who started with Control-IQ between December 2021 and December 2022 were consecutively recruited in 13 Belgian diabetes centres. Data were collected at start and after 4, 8 and 12 months. The primary endpoint was the evolution of time in range (TIR; glucose levels of 3.9-10.0 mmol/l). Data are reported as mean ± SD or least-squares mean (95% CI). A total of 473 adults were included, with a mean age of 38.5±13.1 years and of whom 57.3% were female. TIR increased from 58.8% (95% CI56.7, 60.9) at start to 70.9% (69.1, 72.8) at 12 months (p<0.001). HbA1c decreased from 57.3 mmol/mol (56.1, 58.5) (7.4% [7.3, 7.5]) to 49.5 mmol/mol (48.5, 50.6) (6.7% [6.6, 6.8]) and time <3.9 mmol/l from 4.2% (3.9, 4.6) to 1.9% (1.8, 2.1) (all p<0.001). Participants scored better on the Hypoglycaemia Fear Survey version 2 worry (22.5 [21.3, 23.7] vs 18.1 points [17.0, 19.3]), the Problem Areas in Diabetes - Short Form (7.2 [6.7, 7.8] vs 6.1 points [5.5, 6.7]), and the Diabetes Treatment Satisfaction Questionnaire status (25.5 [24.8, 26.2] vs 31.0 points [30.4, 31.6]) (all p<0.001). The number of self-reported severe hypoglycaemia events (37.5 [21.3, 65.9] vs 15.7 [9.7, 25.3] events per 100 person-years, p=0.002) and work absenteeism days (116.3 [42.8, 315.5] vs 69.3 [25.4, 189.2] days per 100 person-years, p=0.034) decreased. One-year use of Control-IQ was associated with better glucose management, improved diabetes-related quality of life, more treatment satisfaction, less severe hypoglycaemia and less work absenteeism in adults with type 1 diabetes. ClinicalTrials.gov NCT04414280.

Patient-Reported Outcome Measures in Patients with Diabetes Mellitus: Findings from the Diabetes Landeck Cohort.

Maintaining and optimizing quality of life (QoL) is a central issue and one of the most important goals in therapy for patients with chronic diseases, such as diabetes mellitus (DM). Despite its importance, there is little data on the QoL of patients with DM in Austria. The objective of this study was to extend an established population-based cohort, the Diabetes-Landeck cohort, by including patient-reported outcomes. We performed a survey on quality of life (QoL) and treatment satisfaction in patients from the Diabetes-Landeck cohort using the EQ-5D-5L, the problem areas in diabetes survey (PAID), and the diabetes treatment satisfaction questionnaire (DTSQ). Mean sum scores were calculated and compared between patient characteristic subgroups. In total 58 patients were recruited, with a mean age of 63 years and a mean hemoglobin A1c (HbA1c) of 7.1%. The mean sum score of EQ-5D-5L was 92 (SD=10.6), and that of DTSQ and PAID were 32.2 (SD=6.6) and 10.8 (SD=11.6), respectively. Patients with obesity (body mass index ≥ 30 kg/m2) showed a statistically significant decreased mean sum score of EQ-5D-5L and a statistically significant increased mean sum score of DTSQ. Patients with HbA1c ≥7.5% showed a statistically significant decreased mean sum score of DTSQ. We observed patient-reported outcomes significantly associated with obesity and HbA1c, which could be used for targeted patient monitoring. Limited by small sample size and questions in generalizability, we strongly suggest the rollout of a larger study.

Personality in Type 1 Diabetes and the Impact of Personality Traits on the Effects of Introducing Diabetes Technology.

How well new technology is applied to the daily management of type 1 diabetes (T1D) may be highly influenced by personality traits. The number of studies examining how personality traits influence diabetes self-management technologies such as continuous glucose monitoring and carbohydrate counting with automated insulin bolus calculation based on carbohydrate ratios and insulin sensitivity is scarce. Derived from a randomized controlled trial, we aimed to examine the association between personality traits and glycemic and patient-reported outcomes in adults with T1D on multiple daily insulin injections initiating flash glucose monitoring and carbohydrate counting with automated bolus calculation. Personality trait scores from The Five-Factor Inventory-3 were analyzed in 170 individuals. We assessed baseline (n = 168) and changes (n = 34) in HbA1c, and patient-reported outcomes (validated questionnaires on diabetes distress, diabetes treatment satisfaction, diabetes psychosocial self-efficacy, diabetes quality of life) in bivariate and partial correlation analyses with personality traits (neuroticism, extraversion, openness to experience, agreeableness, and conscientiousness). Adjusted for sex, age, and diabetes debut age, higher agreeableness correlated negatively with baseline HbA1c (partial correlation -0.20, p < 0.05) but positively with HbA1c change over time (0.36,p < 0.05). Higher neuroticism score was associated with higher baseline distress (0.39, p < 0.001) and lower baseline psychosocial self-efficacy (-0.43, p < 0.001), quality of life (-0.32, p < 0.001) and treatment satisfaction (-0.18, p < 0.05). This study confirms that personality traits are associated with glycemia and patient-reported outcomes in adults with T1D. Consequently, tailored diabetes management approaches are likely to enhance overall outcomes, especially when incorporating diabetes technology.

Quality of Life in Women With Gestational Diabetes Mellitus and Treatment Satisfaction Upon Intermittently Scanned Continuous Glucose Monitoring

Quality of Life in Women With Gestational Diabetes Mellitus and Treatment Satisfaction Upon Intermittently Scanned Continuous Glucose Monitoring

Level of Satisfaction Among Patients Using Insulin Administered by Pen vs Vial/Syringe. An Observational Prospective Study.

To determine the satisfaction of patients with diabetes mellitus who used subcutaneous insulin application devices in Colombia. An observational prospective study of patients with diabetes mellitus receiving insulin treatment in Colombia. Sociodemographic, comorbidity and pharmacological data were taken from a drug dispensing database. Through telephone calls, satisfaction with application devices was evaluated with Diabetes Treatment Satisfaction Questionnaire status version (DTSQ-s). Satisfaction was considered high at a score ≥30 points. The change in the type of insulin delivery device (ie, from pen to vial/syringe, and from vial/syringe to pen) was evaluated during a 1-year follow-up. A total of 382 patients from 75 cities were selected, with a median age of 66.0 years, and 56.3% were women, and 65.2% were treated with long-acting insulins. The mean DTSQ-s score was 26.6±5.3 points, and 38.7% presented high satisfaction, without statistically significant differences between pen and vial/syringe. A total of 18.8% changed the administration device, mainly those that came from Bogotá-Cundinamarca (OR:2.19; 95% CI:1.01-4.75), in concomitant treatment with other antidiabetic drugs (OR:2.28; 95% CI:1.00-5.22) and those who previously used insulin in vial/syringe (OR:33.90; 95% CI:11.88-96.74). The participants had low satisfaction with the insulin delivery device. No statistically significant differences were found in satisfaction between those who received pen vs vial/syringe insulin, and patients using the latter had a high probability of switching to insulin pen.

Six months of hybrid closed-loop therapy improves diabetes-specific positive well-being, and reduces diabetes distress and fear of hypoglycemia: secondary analysis of a randomized controlled trial

IntroductionThis analysis aimed to investigate diabetes-specific psychological outcomes among adults with type 1 diabetes (T1D) using hybrid closed-loop (HCL) versus standard therapy.Research design and methodsIn this multicenter, open-label, randomized, controlled,...

Psychometric evaluation of the Swedish version of the Diabetes Treatment Satisfaction Questionnaire - Parent version.

Psychometric evaluation of the Swedish version of the Diabetes Treatment Satisfaction Questionnaire - Parent version.

Flash glucose monitoring system help reduce the frequency of hypoglycemia and hypoglycemic fear behavior in type 1 diabetes patients.

Hypoglycemia represents a serious acute complication in individuals with type 1 diabetes mellitus (T1DM). In order to more effectively identify and discriminate the occurrence of hypoglycemic events in patients with T1DM, this study aims to evaluate the impact of two distinct glucose monitoring systems-Flash Glucose Monitoring (FGM) and Continuous Glucose Monitoring (CGM)-on the management of blood glucose levels and the emotional responses associated with hypoglycemic episodes in individuals with T1DM. In this study, a total of 113 patients with type 1 diabetes mellitus were enrolled and allocated to two groups for the implementation of Glucose Monitoring Systems (GMS). The groups consisted of the FreeStyle Libre group (FGM, n=56) and the ipro2 group (CGM, n=57). Participants in both groups utilized GMS at least biannually and completed a set of three questionnaires: the Diabetes Monitoring and Treatment Satisfaction Questionnaire (DMTSQ), the Diabetes Specific Quality of Life (DQOL), and the Chinese Version of the Hypoglycemia Fear Survey II (CFHSII). Clinical data, CGM metrics, and questionnaire scores were collected at the initial visit and after a one-year follow-up period. The glucose coefficient of variation (GCV) and the standard deviation of blood glucose (SDBG) were independently associated with Time Below Range (TBR). Specifically, GCV could predict TBR ≥12%, with a cut-off point of 40.55. This yielded a specificity of 88.10% and a sensitivity of 68.18% in the overall patient population. For the FreeStyle Libre group and the iPro2 group, the cut-off points were 38.69 and 40.55, respectively, with specificities of 0.74 and 0.92, and sensitivities of 0.73 and 0.86, respectively. In the FreeStyle Libre group, where the frequency of use was greater than or equal to five times per year, the hypoglycemic episodes (time/month) and CHFSII-B scores were significantly reduced at follow-up compared to baseline (7.80 ± 10.25 vs 13.95 ± 14.87; 27.37 ± 11.05 vs 38.90 ± 21.61, respectively, all P <0.05). The utilization of multiple Flash Glucose Monitoring (FGM) implementations proved to be valuable in discriminating the occurrence of hypoglycemia and mitigating the fear of hypoglycemic episodes in patients with type 1 diabetes. Within the parameters of Glucose Monitoring Systems (GMS), the glucose glycemic variability (GCV) was identified as a predictive factor for the risk of severe hypoglycemia (TBR > 12%). The optimal cut-off point for GCV was determined to be 40.55.

Curalin supplement as add-on therapy for type 2 diabetes Mellitus

Curalin supplement as add-on therapy for type 2 diabetes Mellitus

Psychometric Properties of the Automated Insulin Delivery: Benefits and Burdens Scale for Adults with Type 1 Diabetes.

Objective: To evaluate the psychometric properties of a patient-reported outcome measure, the Automated Insulin Delivery-Benefits and Burdens Scale (AID-BBS), which was designed to assess benefits and burdens of AID use in adults with type 1 diabetes (T1D). The measure was hypothesized to have validity, reliability, and clinical utility for predicting likelihood of continued use of an AID system. Research Design and Methods: A total of 217 adults with T1D (ages from 18 to 82 years) who were enrolled in an AID system research trial completed AID-BBS items at study midpoint (6 weeks) and at the end of the trial (13 weeks). Data were collected on pre-post glycemic outcomes. Participants completed other patient-reported psychosocial outcome measures (e.g., emotional well-being, diabetes distress, attitudes toward diabetes technology, diabetes treatment satisfaction) at Week 13. Likelihood of continued device use was assessed with three items at 13 weeks. Results: Exploratory factor analysis supported a one-factor structure for each subscale (15-item benefit and 9-item burden subscale) when evaluated separately. Convergent, discriminant, and predictive validity, internal consistency, and test-retest reliability were supported. Benefit and burden subscales at week 6 predicted usage intention above and beyond device impact on glycemic outcomes, also controlling for baseline glycemic outcomes. Conclusion: Findings support the AID-BBS as a psychometrically valid, reliable, and useful instrument for assessing burdens and benefits associated with AID system use in adults with T1D. The measure can be used to help health care providers set realistic expectations and proactively address modifiable burdens. Clinical Trial Registration Number: NCT04200313.

Digital Health Tools and Behavioral Strategies to Increase Engagement With Diabetes Self-Management Education and Support: Design and Feasibility of DM-BOOST.

The purpose of the study was to describe the development and feasibility of implementing the DM-BOOST program in support of an established diabetes self-management education and support (DSMES) program. A patient panel of 4 adults with type 2 diabetes (T2DM) codesigned DM-BOOST. DM-BOOST is a patient-focused program that includes peer-written text messages about diabetes self-management behaviors and digital health training to improve patient portal use and initiate goal setting prior to a scheduled DSMES appointment. Adults with T2DM and A1C ≥8.0% participated in a 6-month feasibility pilot. Participants were randomly assigned (1:1) to receive either DM-BOOST or usual care. Outcomes included DSMES engagement (scheduled and attended DSMES appointments) and changes in diabetes self-efficacy and treatment satisfaction. Pilot participants (n = 60) were 60.0% female with mean age 45.5 years (SD 8.3) and A1C 10.1% (SD 1.8%). All DM-BOOST participants (30/30, 100%) had DSMES appointments scheduled compared to 86.7% of usual care (26/30). DM-BOOST participants had fewer DSMES appointment no-shows/cancellations (3/30, 10%) compared to usual care (10/26, 35%). There was greater improvement in diabetes self-efficacy in the DM-BOOST group compared to usual care and no difference in treatment satisfaction. DM-BOOST, leveraging peer-written text messaging and digital health training, increased DSMES engagement. Implementation of DM-BOOST was determined to be feasible, with several system-level barriers identified, including obtaining provider referrals and scheduling appointments. An effectiveness trial of DM-BOOST is needed to evaluate the impact on clinical outcomes.

PIONEER REAL UK: A Multi-Centre, Prospective, Real-World Study of Once-Daily Oral Semaglutide Use in Adults with Type 2 Diabetes.

Oral semaglutide provides an alternative to injectable glucagon-like peptide-1 receptor agonists (GLP-1RAs) for treatment of type 2 diabetes (T2D). The PIONEER REAL studies evaluate clinical outcomes of oral semaglutide treatment of T2D in a real-world setting. PIONEER REAL UK focused on adults living with T2D in the UK. The multi-centre, prospective and non-interventional single-arm study enrolled 333 participants and followed them for 34-44 weeks. Participants were treated as part of routine clinical practice and had not been previously treated with injectable glucose-lowering medication. The primary endpoint was change in glycated haemoglobin (HbA1C) from baseline to end of study (EOS). Secondary endpoints included change in body weight, proportion of participants with HbA1C < 7% (53 mmol/mol) at EOS and proportion of participants with ≥ 1%-point HbA1C reduction and body weight reduction of ≥ 3% or ≥ 5% at EOS. Treatment satisfaction was assessed by Diabetes Treatment Satisfaction Questionnaire (DTSQ) status and change. Of 333 participants, 299 completed the study and 227 were on treatment at EOS. People treated with oral semaglutide experienced significantly reduced HbA1C by an estimated change of - 1.1%-points (95% CI - 1.27 to - 0.96; P < 0.0001) or - 12.2 mmol/mol (CI - 13.87 to - 10.47; P < 0.0001). Estimated change in body weight was - 4.8 kg (CI - 5.47 to - 4.12; P < 0.0001). At EOS, an HbA1C level < 7% (53 mmol/mol) was recorded in 46.3% of participants. A ≥ 1%-point reduction in HbA1C combined with a ≥ 3% reduction in body weight was observed in 36.4% of participants, and 27.1% had a ≥ 1%-point reduction in HbA1C and a ≥ 5% body weight reduction. Treatment satisfaction improved significantly during the study. No new safety concerns or cases of severe hypoglycaemia were reported. People living with T2D in the UK experienced a meaningful decrease in HbA1C and body weight after initiation of oral semaglutide treatment. No new safety issues were observed. ClinicalTrials.gov: NCT04862923. Graphical plain language summary available for this article.

Oral Semaglutide in Type 2 Diabetes: Clinical-Metabolic Outcomes and Quality of Life in Real-World Practice.

Background: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are a novel class of incretin mimetics for treating type 2 diabetes (T2D). This study evaluated the impact of semaglutide, the first oral GLP-1RA, on glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), and body composition and anthropometric parameters. Additionally, the effects on cardiovascular risk factors and quality of life (QoL) in T2D patients were assessed. Methods: A prospective observational study with a six-month follow-up was conducted. Clinical parameters, including HbA1c, FPG, anthropometric measurements, blood pressure, cardiovascular risk factors, Diabetes Treatment Satisfaction Questionnaire (DTSQ) responses, and Short Form (36) Health Survey (SF-36) responses, were collected at baseline (T0) and at six months (T1). Results: Sixty-one subjects were enrolled, with there being an average T2D duration of 4.67 ± 3.93 years. Significant decreases were observed in HbA1c (µ = -1.24; SD = 1.33; p < 0.05), FPG (µ = -31.01 mg/dL; SD = 41.71; p < 0.05), body composition and anthropometric parameters (p < 0.05), and cardiovascular risk factors (p < 0.05), with an increase in DTSQ scores (p < 0.05). Conclusions: The administration of 14 mg/day oral semaglutide improved several clinical parameters after six months of treatment. These findings suggest semaglutide is effective in improving glycemic control, weight management, and some cardiovascular risk factors in T2D patients.

Diabetes treatment satisfaction among a multi-ethnic Aotearoa New Zealand population with uncontrolled type 2 diabetes mellitus.

To assess whether diabetes treatment satisfaction differs by ethnicity among participants with insufficient glycaemic control of type 2 diabetes mellitus in a clinical trial involving additional oral diabetes medications. Patient satisfaction is used as an indicator of healthcare quality. However, data on patients' diabetes treatment satisfaction in the context of insufficient glycaemic control is limited. Individuals with type 2 diabetes and an HbA1c of 58-110mmol/mol (7.5-12.5%) were recruited across Aotearoa New Zealand to participate in an 8-month randomised crossover study of vildagliptin and pioglitazone as add-on therapy to metformin and/or sulfonylurea. Participants completed the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at baseline pre-randomisation. Treatment satisfaction scores were compared between ethnic groups and other characteristics using the analysis of variance and linear regression. Perceived hyper- and hypoglycaemia were summarised separately. Between February 2019 and March 2020, 346 participants (41% women, 32% Pacific peoples, 23% Māori, 26% European) completed the DTSQ. Mean (SD) age was 57.5 (10.9) years, diabetes duration was 9 (6.3) years and HbA1c was 75 (12)mmol/mol (9.0[3.2]%). At study entry, 40% were receiving monotherapy for diabetes. Treatment satisfaction was rated highly, with a score of 29(6) (interquartile range 25-33). Pacific peoples and older people reported greater treatment satisfaction than other groups (p<0.001). Diabetes treatment satisfaction was high, particularly among Pacific peoples, despite suboptimal glycaemic control and insufficient glucose-lowering therapy.

PIONEER REAL Sweden: A Multicentre, Prospective, Real-World Observational Study of Oral Semaglutide Use in Adults with Type2 Diabetes in Swedish Clinical Practice.

The study was designed to assess outcomes with once-daily oral semaglutide in adults with type2 diabetes (T2D) naïve to injectable glucose-lowering agents, in Swedish clinical practice. In this non-interventional, multicentre study, participants initiated oral semaglutide and were followed for 34-44weeks. The primary endpoint was glycated haemoglobin (HbA1c) change from baseline to end of study (EOS). Secondary endpoints included body weight (BW) change from baseline to EOS, proportion of participants achieving HbA1c < 7%, and proportion achieving both a HbA1c reduction ≥ 1% and BW reduction of ≥ 3% or ≥ 5%, at EOS. Participants completed Diabetes Treatment Satisfaction Questionnaires (DTSQ status/change) and a dosing conditions questionnaire. A total of 187 participants (mean age 62.5years) initiated oral semaglutide. Baseline mean HbA1c and BW were 7.8% (n = 177) and 96.9kg (n = 165), respectively. Estimated mean changes in HbA1c and BW were - 0.88%-points (95% confidence interval [CI] - 1.01 to - 0.75; P < 0.0001) and - 4.72% (95%CI - 5.58 to - 3.86; P < 0.0001), respectively. At EOS, 64.6% of participants had HbA1c < 7%, and 22.9% achieved HbA1c reduction of ≥ 1% and BW reduction of ≥ 5%. DTSQ status and change scores improved by 1.44 (P = 0.0260) and 12.3 points (P < 0.0001), respectively. Oral semaglutide was easy or very easy to consume for 86.4% of participants. Most common adverse events (AEs) were gastrointestinal disorders; nine participants (4.8%) had serious AEs; one (0.5%) experienced severe hypoglycaemia. In this real-world study population, we observed significant reductions in HbA1c and BW in people living with T2D when prescribed semaglutide tablets as part of routine clinical practice in Sweden, with improved treatment satisfaction among participants and no new safety concerns. NCT04601753.

Systematic Improvement of a Bolus Calculator That Is on the Market: A User-Centric Approach.

State-of-the-art diabetes self-management includes the usage of (software) tools, such as Bolus Calculators, to support patients with their therapeutic decisions. The development of such medical devices comes with strict obligations to ensure the safety and performance for the user; however, it is also necessary to continue to evaluate such aspects after the products are introduced into the market. In addition, such aspects cannot always be sufficiently validated by clinical trials; they need real-world evaluation to systematically improve such tools while they are on the market. The approach described here uses innovative ways of generating user-centric evidence to improve the bolus calculator, including (1) human factor engineering, (2) analysis of glycemic real-world data, (3) patient-reported outcomes, and (4) machine-generated behavioral measurements. The combination of the diverse techniques to optimize the bolus calculator triggered changes in the user experience: a significant reduction in hypoglycemic events, -0.52% (±0.05), P < .01, n=3480, an increased diabetes treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire [DTSQ] +9.90, P < .01, n=217), as well as an increased acceptance rate of bolus calculations, +15.73 (±0.89), P < .01, n=3436, were observed. Altogether, human factor engineering and different forms of real-world data support fast and direct adaptations and improvements in products used for diabetes therapy.

Factors influencing diabetes treatment satisfaction in the INtegrating DEPrEssioN and Diabetes treatmENT randomized clinical trial: A multilevel model analysis.

Patient satisfaction is associated with positive diabetes outcomes. However, there are no identified studies that evaluate both patient- and clinic-level predictors influencing diabetes care satisfaction longitudinally. Data from the INtegrating DEPrEssioN and Diabetes treatmENT trial was used to perform the analysis. We used fixed and random effects models to assess whether and how changes in patient-level predictors (treatment assignment, depression symptom severity, systolic blood pressure, body mass index, LDL cholesterol, and haemoglobin A1C) from 0 to 24 months and clinic-level predictors (visit frequency, visit cost, number of specialists, wait time, time spent with healthcare provider, and receiving verbal reminders) measured at 24 months influence diabetes care satisfaction from 0 to 24 months. Model 1 (patient-level predictors) accounted for 7% of the change in diabetes satisfaction and there was a significant negative relationship between change in depressive symptoms and care satisfaction (β = -0.23, SE = 0.12, p < 0.05). Within Model 1, 2% of the variance was explained by clinic-level predictors. Model 2 included both patient- and clinic-level predictors and accounted for 18% of the change in diabetes care satisfaction. Within Model 2, 9% of the variance was attributed to clinic-level predictors. There was also a cross-level interaction where the change in depression had less of an impact on the change in satisfaction for those who received a verbal reminder (β = -0.11, SE = 0.21, p = 0.34) compared with those who did not receive a reminder (β = -0.62, SE = 0.08, p < 0.01). Increased burden of depressive symptoms influences diabetes care satisfaction. Clinic-level predictors also significantly influence diabetes care satisfaction and can reduce dissatisfaction in primary care, specifically, reminder calls from clinic staff.