Frank Nobels

Objectives: To study real-world effect of switching to Insulin Glargine 300 U/mL (Gla-300) on glucose metrics in people with type 1 diabetes. Methods: This retrospective secondary-use study compared 151 adults who switched to Gla-300 from first-generation long-acting insulins (Switchers) to 281 propensity-score matched controls (Non-switchers) who continued first-generation long-acting insulins. Primary endpoint was difference in time in range (TIR) evolution. A fictive “switching” date was assigned to Non-switchers to facilitate between-group comparisons. Results: In the period before switching, TIR decreased numerically for people in whom Gla-300 was eventually initiated (−0.05%/month [−0.16 to 0.07]), while it increased for matched controls (0.08%/month [0.02 to 0.015]; between-group difference P = 0.047). After Gla-300-initiation, Switchers had similar TIR increase compared to Non-switchers ( P = 0.531). Switchers used higher basal dose than before switch (Δ0.012 U/[kg·d] [0.006 to 0.018]; P < 0.0001). Conclusion: In real-life, Gla-300 was typically initiated in people where TIR was decreasing, which was reversed after switch using slightly higher basal insulin dose. ClinicalTrials: ClinicalTrials.gov number NCT05109520.

Objective: Achieving good metabolic control in people with type 1 diabetes (T1D) remains a challenge, despite the evolutions in diabetes technologies over the past decade. Here we investigate the evolution of metabolic control in people with T1D, where care is provided by specialized centers with access to technology, diabetes education, and regular follow-up. Methods: Data were cross-sectionally collected between 2010 and 2018 from more than 100 centers in Belgium. The evolutions over time of hemoglobin A1C (HbA1c), low-density lipoprotein (LDL) cholesterol, and systolic blood pressure (SBP) were investigated, together with the evolutions of use of insulin pump (continuous subcutaneous insulin infusion [CSII]), continuous glucose monitoring (CGM), and lipid-lowering and antihypertensive drugs. Association of HbA1c with gender, age, diabetes duration, and technology use was analyzed on the most recent cohort. Results: The study population contained data from 89,834 people with T1D (age 1–80 years). Mean HbA1c decreased from 65 mmol/mol (8.1%) in 2010–2011 to 61 mmol/mol (7.7%) in 2017–2018 ( P < 0.0001, adjusted for gender, age, diabetes duration, and technology use). Respectively, mean LDL cholesterol decreased from 2.45 mmol/L (94.6 mg/dL) to 2.29 mmol/L (88.5 mg/dL) ( P < 0.0001, adjusted for gender, age, and diabetes duration), and mean SBP remained stable. CGM usage increased, whereas the use of CSII and lipid-lowering and antihypertensive drugs remained stable. Gender, age, diabetes duration, and technology use were independently associated with HbA1c. Conclusions: Our real-world data show that metabolic and lipid control improved over time in a system where T1D care is organized through specialized multidisciplinary centers with emphasis on linking education to provision of technology, and its quality is monitored.

Despite advances in diagnosis and treatment of type 2 diabetes, suboptimal metabolic control persists. Patient education in diabetes has been proved to enhance self-efficacy and guideline-driven treatment, however many people with type 2 diabetes do not have access to or do not participate in self-management support programmes. Tele-education and telecoaching have the potential to improve accessibility and efficiency of care, but there is a slow uptake in Europe. Patient and provider acceptance in a local context is an important pre-condition for implementation. The aim of the study was to explore the perceptions of patients, nurses and general practitioners (GPs) regarding telecoaching in type 2 diabetes. Mixed-method study embedded in a clinical trial, in which a nurse-led target-driven telecoaching programme consisting of 5 monthly telephone sessions of +/− 30 min was offered to 287 people with type 2 diabetes in Belgian primary care. Intervention attendance and satisfaction about the programme were analysed along with qualitative data obtained during post-trial semi-structured interviews with a purposive sample of patients, general practitioners (GPs) and nurses. The perceptions of patients and care providers about the intervention were coded and the themes interpreted as barriers or facilitators for adoption. Of 252 patients available for a follow-up analysis, 97.5 % reported being satisfied. Interviews were held with 16 patients, 17 general practitioners (GPs) and all nurses involved (n = 6). Themes associated with adoption facilitation were: 1) improved diabetes control; 2) need for more tailored patient education programmes offered from the moment of diagnosis; 3) comfort and flexibility; 4) evidence-based nature of the programme; 5) established cooperation between GPs and diabetes educators; and 6) efficiency gains. Most potential barriers were derived from the provider views: 1) poor patient motivation and suboptimal compliance with “faceless” advice; 2) GPs’ reluctance in the area of patient referral and information sharing; 3) lack of legal, organisational and financial framework for telecare. Nurse-led telecoaching of people with type 2 diabetes was well-accepted by patients and providers, with providers being in general more critical in their reflections. With increasing patient demand for mobile and remote services in healthcare, the findings of this study should support professionals involved in healthcare policy and innovation. NCT01612520, registered prior to recruitment on 4th June 2012.

Assessment of quality of care using classical threshold measures (TM) is open to debate. Measures that take into account the clinician’s actions and the longitudinal nature of chronic care are more reliable, although their major limitation is that they require more sophisticated electronic health records. We created a clinical action measure (CAM) for the control of LDL and non-HDL cholesterol from low-complexity data, and investigated how quality of care in individual diabetes centres based on the CAM is related to that based on the classical TM. Data was used from 3421 diabetes patients treated in 95 centres, collected in two consecutive retrospective data collections. Patients met the TM when their index value was below target. Patients met the CAM when their index value was below target or above target but for whom treatment initiation or intensification, or possible contraindication, was indicated. Based on the TM, 60–70 % of the patients received good care. This percentage increased significantly using the CAM (+5 %, p < 0.001). At the centre level, the CAM was associated with a higher median score, and a change in position among centres (‘poor’, ‘good’ or ‘excellent’ performer) for 5–10 % of the centres. Judging quality of diabetes care of a centre based on a TM may be misleading. Low-complexity data available from a quality improvement initiative can be used to construct a more fair and feasible measure of quality of care.

Our aim was to evaluate the difference in pregnancy outcomes and characteristics between insulin- and diet-treated women with gestational diabetes (GDM). Retrospective analysis of the medical files from 2010–2013 of women with GDM diagnosed with the Carpenter & Coustan criteria attending two clinics, one in a university and another in a non-university hospital. Characteristics associated with insulin use were analyzed. Multivariable logistic regression was used to adjust for confounders. For women attending the university hospital, indices of insulin sensitivity such as the reciprocal of the homeostasis model assessment of insulin resistance (1/HOMA-IR) and an index of beta-cell function, the Insulin Secretion-Sensitivity Index-2 (ISSI-2) were calculated. Over a 4 year period, 601 women were identified with GDM of whom 22.9 % were obese at first prenatal visit. 24.2 % needed insulin. Insulin did not prevent adverse outcomes, as women on insulin had higher rates of large-for-gestational age infants (LGA) (28.5 % vs. 13.1 %, p < 0.0001) and more cesarean sections (44.1 % vs. 27.0 %, p = 0.001), remaining significant after adjustment for confounders. Compared to diet-treated women, women on insulin more often had an ethnic minority background (33.3 % vs. 21.6 %, p = 0.004), more often had a history of GDM (21.5 % vs. 10.4 %, p = 0.002), were more often multiparous (59.3 % vs. 47.6 %, p = 0.044) and were diagnosed with GDM earlier in pregnancy (weeks 25.3 ± 4.9 vs. 27.1 ± 3.7, p < 0.0001). When undergoing an oral glucose tolerance test, women treated with insulin had a higher fasting glycaemia (97.6 ± 18.8 vs.87.7 ± 10.3, p < 0.0001), a higher 1-hour glycaemia (197.7 ± 30.1 vs.184.5 ± 25.8, p < 0.0001), a higher 2-hour glycaemia (185.2 ± 28.5 vs. 175.0 ± 22.8, p < 0.0001), more often 3 and 4 abnormal values (58.1 % vs. 37.8 %, p < 0.0001 and 24.8 % vs. 7.7 %, p < 0.0001) and higher HbA1c levels (5.5 ± 0.6 vs 5.2 ± 0.5, p < 0.0001). ISSI-2 (1.3 ± 0.5 vs. 1.7 ± 0.5, p < 0.0001) and 1/HOMA-IR [0.01 (0.001–0.002) vs. 0.02 (0.01–0.03), p = 0.027] were lower in women on insulin. Women on insulin more often received corticoids in preparation of preterm delivery (11.0 % vs. 2.4 %, p < 0.0001). Compared to diet-treated women with GDM, women treated with insulin have a higher risk profile, impaired beta-cell function and lower insulin sensitivity. Rates of LGA and cesarean sections were higher in insulin-treated women.

Despite the efforts of the healthcare community to improve the quality of diabetes care, about 50% of people with type 2 diabetes do not reach their treatment targets, increasing the risk of future micro-and macro-vascular complications. Diabetes self-management education has been shown to contribute to better disease control. However, it is not known which strategies involving educational programs are cost-effective. Telehealth applications might support chronic disease management. Transferability of successful distant patient self-management support programs to the Belgian setting needs to be confirmed by studies of a high methodological quality. “The COACH Program” was developed in Australia as target driven educational telephone delivered intervention to support people with different chronic conditions. It proved to be effective in patients with coronary heart disease after hospitalization. Clinical and cost-effectiveness of The COACH Program in people with type 2 diabetes in Belgium needs to be assessed.

To investigate the safety and efficacy of switching to biphasic insulin aspart (BIAsp) 30, 50 or 70 in patients with type 2 diabetes previously treated with biphasic human insulin (BHI) 30/50 (with or without oral glucose-lowering drugs) in routine clinical practice. This was a 26-week, prospective, observational study conducted in Belgium and Luxembourg. Data were collected at baseline before patients switched and at 12 and 26 weeks after starting BIAsp 30, 50 or 70. Safety endpoints were incidence and rate of hypoglycemia (major, minor, nocturnal), adverse events and body-weight changes. Efficacy assessments included HbA_1c and 7-point self-measured plasma glucose (PG) profiles. Changes from baseline were analyzed using paired t-tests. Of 592 patients analyzed, 72% switched to twice-daily BIAsp and 20% to three-times daily BIAsp. Upon switching, 27% of patients received intensified treatment (i.e., more daily doses than with their previous BHI). At all three data-collection points, approximately two-thirds of patients were taking BIAsp 30 and approximately one-third were taking BIAsp 50; very few patients took BIAsp 70. Mean total daily insulin dose increased significantly from baseline (51.2 U) to 26 weeks (54.3 U) and mean time of intake before meals changed from 17 minutes for BHI to ∼3 minutes with BIAsp. Incidence of hypoglycemia did not change during the study (baseline: 30.7%, week 26: 29.2%). HbA_1c improved significantly from baseline (7.9 %) to weeks 12 and 26 (7.6% and 7.5%, respectively; p < 0.001). Mean PG profiles also showed significant improvements. As this is an observational study, some limitations should be considered such as the absence of a control group and a possible bias of increased medical attention. Patients with long-standing type 2 diabetes can switch safely from BHI to BIAsp therapy, even if they receive intensified treatment, and they have no problems changing the timing of their insulin injections.

To investigate the effect of physician- and patient-specific feedback with benchmarking on the quality of care in adults with type 2 diabetes mellitus (T2DM).