IntroductionMany individuals with type 2 diabetes mellitus (T2DM) experience "psychological insulin resistance". Consequently, it could be expected that insulin therapy may have negative effects on... Show moreIntroductionMany individuals with type 2 diabetes mellitus (T2DM) experience "psychological insulin resistance". Consequently, it could be expected that insulin therapy may have negative effects on psychological outcomes and well-being. Therefore, this study compared health status and psychosocial functioning of individuals with T2DM using only oral antihyperglycemic agents (OHA) and on insulin therapy (with or without OHA).Materials and MethodsIn this cross-sectional study, we used baseline data of a cluster randomized controlled trial conducted in 55 Dutch general practices in 2005. Health status was measured with the Short Form (SF)-36 (scale 0-100) and psychosocial functioning with the Diabetes Health Profile (DHP, scale 0-100). To handle missing data, we performed multiple imputation. We used linear mixed models with random intercepts per general practice to correct for clustering at practice level and to control for confounding.ResultsIn total, 2,794 participants were included in the analysis, their mean age was 65.8 years and 50.8% were women. Insulin-users (n = 212) had a longer duration of T2DM (11.0 versus 5.6 years) and more complications. After correcting for confounders and multiple comparisons, insulin-users reported significantly worse outcomes on vitality (SF-36, adjusted difference -5.7, p=0.033), general health (SF-36, adjusted difference -4.8, p=0.043), barriers to activity (DHP, adjusted difference -7.2, p<0.001), and psychological distress (DHP, adjusted difference -3.7, p=0.004), all on a 0-100 scale.DiscussionWhile previous studies showed similar or better health status in people with type 2 diabetes receiving insulin therapy, we found that vitality, general health and barriers to activity were worse in those on insulin therapy. Although the causality of this association cannot be established, our findings add to the discussion on the effects of insulin treatment on patient-reported outcomes in daily practice. Show less
Objective To investigate the effect of diabetes self-management education and support via a smartphone app in individuals with type 2 diabetes on insulin therapy.Research design and methods Open... Show moreObjective To investigate the effect of diabetes self-management education and support via a smartphone app in individuals with type 2 diabetes on insulin therapy.Research design and methods Open two-arm multicenter parallel randomized controlled superiority trial. The intervention group (n=115) received theory and evidence-based self-management education and support via a smartphone app (optionally two or six times per week, once daily at different times). The control group (n=115) received care as usual. Primary outcome: HbA1c at 6 months. Other outcomes included HbA1c <= 53 mmol/mol (<= 7%) without any hypoglycemic event, body mass index, glycemic variability, dietary habits and quality of life. We performed multiple imputation and regression models adjusted for baseline value, age, sex, diabetes duration and insulin dose.Results Sixty-six general practices and five hospital outpatient clinics recruited 230 participants. Baseline HbA1c was comparable between groups (8.1% and 8.3%, respectively). At 6 months, the HbA1c was 63.8 mmol/mol (8.0%) in the intervention vs 66.2 mmol/mol (8.2%) in the control group; adjusted difference -0.93 mmol/mol (-0.08%), 95% CI -4.02 to 2.17 mmol/mol (-0.37% to 0.20%), p=0.557. The odds for achieving an HbA1c level <= 7% without any hypoglycemic event was lower in the intervention group: OR 0.87, 95% CI 0.33 to 2.35. There was no effect on secondary outcomes. No adverse events were reported.Conclusions This smartphone app providing diabetes self-management education and support had small and clinically not relevant effects. Apps should be more personalized and target individuals who think the app will be useful for them. Show less
Objectives To determine at what glycated haemoglobin (HbA1c) level physicians from eight European countries would initiate insulin in type 2 diabetes, which physician or practice related factors... Show moreObjectives To determine at what glycated haemoglobin (HbA1c) level physicians from eight European countries would initiate insulin in type 2 diabetes, which physician or practice related factors influenced this level and whether physicians would differentiate between a younger uncomplicated patient and an older patient with comorbidities.Design Cross-sectional study with data from the Guideline Adherence to Enhance Care study.Setting and participants 410 physicians from both primary and secondary care from Belgium, France, Germany, Italy, Ireland, Sweden, the Netherlands and the UK.Outcome measures Physicians were asked at which HbA1c level they would initiate insulin for a young, uncomplicated patient (vignette 1) and for an older, complicated patient (vignette 2). We evaluated differences in HbA1c levels between physicians from different countries using analysis of variance. To identify physician and practice related factors associated with HbA1c level at initiation of insulin, we performed multivariable linear regression. Multiple imputation was used to deal with missing data.Results In Germany, Ireland, Sweden, the Netherlands and the UK, the HbA1c levels for initiating insulin in vignette 2 (range: 60.0 to 66.0mmol/mol; 7.6% to 8.2%) were higher than for vignette 1 (range: 57.2 to 64.2mmol/mol; 7.4% to 8.0%). In multivariable analysis, the HbA1c level at which insulin was initiated only differed between countries (vignette 1): Dutch physicians initiated insulin at a lower HbA1c level compared with Belgium, France and the UK. No physician or practice factors were independently associated with HbA1c level at insulin initiation.Conclusions When deciding on individualised HbA1c targets for insulin initiation, physicians from five countries took patient's age and comorbidity into account. The HbA1c level at which physicians would initiate insulin therapy differed between countries. Show less
Boels, A.M.; Rutten, G.; Zuithoff, N.; Wit, A. de; Vos, R. 2018
To compare the proportion of cardiometabolic well-controlled type 2 diabetes mellitus (T2DM) patients according to a clearly defined, simple personalised approach, versus the 'one-size-fits-all'... Show moreTo compare the proportion of cardiometabolic well-controlled type 2 diabetes mellitus (T2DM) patients according to a clearly defined, simple personalised approach, versus the 'one-size-fits-all' approach.|Observational study using routine data of primary care type 2 diabetes patients in the Netherlands. The proportions of patients that reach the targets for HbA1c, systolic blood pressure and low-density lipoprotein cholesterol in the two different approaches were compared.|Of the 890 patients (54.7% men, mean age 62.7 years), 31.8% were well-controlled according to the individualised approach and 24.8% according to the 'one-size-fits-all' approach. For specific subgroups personalising the treatment led to a 5.2%, 27.3% and 45.6% increase of patients achieving low-density lipoprotein cholesterol, HbA1c and systolic blood pressure goals respectively.|A clearly defined and relatively simple personalised approach leads to a higher proportion of T2DM patients considered as cardiometabolic well-controlled. This approach may especially be beneficial for patients aged ≥70 years on more than metformin monotherapy (HbA1c) and for patients aged ≥80 years (SBP). Precisely these patients are suggested not to benefit from stricter HbA1c or SBP targets, whereas they may experience more adverse effects (e.g. hypoglycaemia, postural hypotension) when a stricter target value is pursued. Show less
To compare the proportion of cardiometabolic well-controlled type 2 diabetes mellitus (T2DM) patients according to a clearly defined, simple personalised approach, versus the 'one-size-fits-all'... Show moreTo compare the proportion of cardiometabolic well-controlled type 2 diabetes mellitus (T2DM) patients according to a clearly defined, simple personalised approach, versus the 'one-size-fits-all' approach.|Observational study using routine data of primary care type 2 diabetes patients in the Netherlands. The proportions of patients that reach the targets for HbA1c, systolic blood pressure and low-density lipoprotein cholesterol in the two different approaches were compared.|Of the 890 patients (54.7% men, mean age 62.7 years), 31.8% were well-controlled according to the individualised approach and 24.8% according to the 'one-size-fits-all' approach. For specific subgroups personalising the treatment led to a 5.2%, 27.3% and 45.6% increase of patients achieving low-density lipoprotein cholesterol, HbA1c and systolic blood pressure goals respectively.|A clearly defined and relatively simple personalised approach leads to a higher proportion of T2DM patients considered as cardiometabolic well-controlled. This approach may especially be beneficial for patients aged ≥70 years on more than metformin monotherapy (HbA1c) and for patients aged ≥80 years (SBP). Precisely these patients are suggested not to benefit from stricter HbA1c or SBP targets, whereas they may experience more adverse effects (e.g. hypoglycaemia, postural hypotension) when a stricter target value is pursued. Show less
Patients with type 2 diabetes (T2DM) on insulin therapy are less satisfied with their diabetes treatment than those on oral hypoglycaemic therapies or lifestyle advice only. Determinants of... Show morePatients with type 2 diabetes (T2DM) on insulin therapy are less satisfied with their diabetes treatment than those on oral hypoglycaemic therapies or lifestyle advice only. Determinants of satisfaction in patients with T2DM on insulin therapy are not clearly known. The aim of this study was to determine the association of treatment satisfaction with demographic and clinical characteristics of patients with T2DM.|For this study we used data from the GUIDANCE (Guideline Adherence to Enhance Care) study, a cross-sectional study among 7597 patients with T2DM patients from Belgium, France, Germany, Ireland, Italy, Sweden, the Netherlands and the UK. The majority of patients were recruited from primary care. Treatment satisfaction was assessed by the Diabetes Treatment Satisfaction Questionnaire (DTSQ, score 0-36; higher scores reflecting higher satisfaction). To determine which patient characteristics and laboratory values were independently associated with treatment satisfaction, a linear mixed model analysis was used.|In total, 1984 patients on insulin were analysed; the number of included patients per country ranged from 166 (the Netherlands) to 384 (Italy).|The mean DTSQ score was 28.50±7.52 and ranged from 25.93±6.57 (France) to 30.11±5.09 (the Netherlands). Higher DTSQ scores were associated with having received diabetes education (β 1.64, 95% CI 0.95 to 2.32), presence of macrovascular complications (β 0.76, 95% CI 0.21 to 1.31) and better health status (β 0.08 for every one unit increase on a 0-100 scale, 95% CI 0.07 to 0.10). Lower DTSQ scores were associated with more frequently perceived hyperglycaemia (β -0.32 for every 1 unit increase on a seven-point Likert scale, 95% CI -0.50 to -0.13), and higher glycated haemoglobin (β -0.52 for every percentage increase, 95% CI -0.75 to -0.29).|A number of factors including diabetes education, perceived and actual hyperglycaemia and macrovascular complications are associated with treatment satisfaction. Self-management education programmes should incorporate these factors for ongoing support in patients with T2DM. Show less
