Metabolic health in people living with type 1 diabetes in Belgium: a repeated cross-sectional study.

AIMS/HYPOTHESIS: Metabolic abnormalities such as central obesity, insulin resistance, dyslipidaemia and hypertension, often referred to as 'the metabolic syndrome' (or 'combined metabolic abnormalities'), are increasingly being identified in people living with type 1 diabetes, accelerating the risk for CVD. As a result, in recent years, treatment in people living with type 1 diabetes has shifted to improving overall metabolic health rather than glucose control alone. In Belgium, diabetes care for people living with type 1 diabetes is centrally organised. The Initiative for Quality Improvement and Epidemiology in Diabetes, imposed by the Belgian health insurance system, has systematically collected data from patients on intensive insulin therapy treated in all 101 diabetes clinics in Belgium since 2001. The aim of this real-world study is to describe the evolution of treatment and metabolic health, including the prevalence of obesity and combined metabolic abnormalities, in people living with type 1 diabetes over the past 20 years, and to compare the treatment and prevalence of complications between those with and without combined metabolic abnormalities. METHODS: We analysed data on adults (≥16 years old) living with type 1 diabetes, who were diagnosed at age ≤45 years and who had a diabetes duration ≥1 year, collected between 2001 and 2022. The evolution of HbA1c, BMI, LDL-cholesterol, systolic BP, lipid-lowering therapy and antihypertensive therapy over time was analysed. The prevalence of individual and multiple metabolic abnormalities according to various definitions of the metabolic syndrome/combined metabolic abnormalities was analysed, and the association between combined metabolic abnormalities and metabolic health indicators, complications and treatment was investigated in the 2022 data. RESULTS: The final dataset consisted of 26,791 registrations of adults living with type 1 diabetes collected between 2001 and 2022. Although glycaemic and lipid control generally improved over time, the prevalence of obesity strongly increased (12.1% in 2001 vs 21.7% in 2022, p<0.0001), as did the presence of combined metabolic abnormalities (WHO criteria: 26.9% in 2001 vs 42.9% in 2022 in women, p<0.0001; 30.4% in 2001 vs 52.1% in 2022 in men, p<0.0001; WHO criteria without albuminuria: 22.3% in 2001 vs 40.6% in 2022 in women, p<0.0001; 25.1% in 2001 vs 49.2% in 2022 in men, p<0.0001; NCEP-ATPIII criteria: 39.9% in 2005 vs 57.2% in 2022 in women, p<0.0001; 40.8% in 2005 vs 60.9% in 2022 in men, p<0.0001; IDF criteria: 43.9% in 2005 vs 59.3% in 2022 in women, p<0.001; 33.7% in 2005 vs 50.0% in 2022 in men, p<0.0001). People with combined metabolic abnormalities had higher glucose levels compared to those without combined metabolic abnormalities (HbA1c >58 mmol in men: 48.9% vs 36.9%; HbA1c >58 mmol in women: 53.3% vs 41.1%, p<0.0001). People with combined metabolic abnormalities were more often treated with adjunct therapies such as metformin, sodium-glucose transport protein 2 inhibitors and glucagon-like peptide-1 receptor agonists. In both men and women, the presence of combined metabolic abnormalities was strongly related to the presence of eye complications, peripheral neuropathy, chronic kidney disease and CVD, corrected for age, diabetes duration and HbA1c. CONCLUSIONS/INTERPRETATION: Overweight, obesity and combined metabolic abnormalities are increasingly being identified in people living with type 1 diabetes, further accelerating the risk of microvascular and macrovascular complications. Early identification of the presence of combined metabolic abnormalities should enable therapeutic interventions to be modified towards multifactorial approaches, with attention to education on avoidance of overweight (e.g. dietary counselling) in addition to strict glycaemic control and intensification of use of antihypertensive agents and statins. Use of adjunct therapies in this population as a tool should be explored more thoroughly to reduce risk of complications.

Cost-utility analysis of Dexcom G6 real-time continuous glucose monitoring versus FreeStyle Libre 1 intermittently scanned continuous glucose monitoring in adults with type 1 diabetes in Belgium.

AIMS/HYPOTHESIS: The aim of this study was to assess the long-term cost-effectiveness of Dexcom G6 real-time continuous glucose monitoring (rtCGM) with alert functionality compared with FreeStyle Libre 1 intermittently scanned continuous glucose monitoring (isCGM) without alerts in adults with type 1 diabetes in Belgium. METHODS: The IQVIA CORE Diabetes Model was used to estimate cost-effectiveness. Input data for the simulated baseline cohort were sourced from the randomised ALERTT1 trial (ClinicalTrials.gov. REGISTRATION NO: NCT03772600). The age of the participants was 42.9 ± 14.1 years (mean ± SD), and the baseline HbA1c was 57.8 ± 9.5 mmol/mol (7.4 ± 0.9%). Participants using rtCGM showed a reduction in HbA1c of 3.6 mmol/mol (0.36 percentage points) based on the 6-month mean between-group difference. In the base case, both rtCGM and isCGM were priced at €3.92/day (excluding value-added tax [VAT]) according to the Belgian reimbursement system. The analysis was performed from a Belgian healthcare payer perspective over a lifetime time horizon. Health outcomes were expressed as quality-adjusted life years. Probabilistic and one-way sensitivity analyses were used to account for parameter uncertainty. RESULTS: In the base case, rtCGM dominated isCGM, resulting in lower diabetes-related complication costs and better health outcomes. The associated main drivers favouring rtCGM were lower HbA1c, fewer severe hypoglycaemic events and reduced fear of hypoglycaemia. The results were robust under a wide range of one-way sensitivity analyses. In models where the price of rtCGM is €5.11/day (a price increase of 30.4%) or €12.34/day (a price increase of 214.8%), rtCGM was cost-neutral or reached an incremental cost-effectiveness ratio of €40,000 per quality-adjusted life year, respectively. CONCLUSIONS/INTERPRETATION: When priced similarly, Dexcom G6 rtCGM with alert functionality has both economic and clinical benefits compared with FreeStyle Libre 1 isCGM without alerts in adults with type 1 diabetes in Belgium, and appears to be a cost-effective glucose monitoring modality. Trial registration ClinicalTrials.gov NCT03772600.

Assessment and management of diabetes-related foot infection according to the new International Working Group on the Diabetic Foot guidelines 2023-Multidisciplinary grand rounds.

Diabetes-related foot disease is a serious and common complication for people with diabetes mellitus. The gold standard care for a person with diabetes-related foot disease is the involvement of a multidisciplinary foot team engaged in evidence-based care. To date, there are seven International Working Group on the Diabetic Foot (IWGDF) guidelines published to assist healthcare providers in managing diabetes-related foot disease around the world. This review discusses the acute management of diabetes-related foot infection with insights from experts of various specialities (internal medicine, infectious disease, vascular surgery, radiology) with a discussion on the implementation of IWGDF guidelines in real life practice and the challenges that healthcare providers may face.

The impact of diabetes on mortality rates after lower extremity amputation.

OBJECTIVE: To assess the impact of diabetes, amputation level, sex and age on mortality rates after lower extremity amputation (LEA) in Belgium, and to assess temporal trends in one-year survival rates from 2009 to 2018. METHODS: Nationwide data on individuals who underwent minor and major LEA from 2009 to 2018 were collected. Kaplan-Meier survival curves were constructed. A Cox regression model with time-varying coefficients was used to estimate the likelihood of mortality after LEA in individuals with or without diabetes. Matched amputation-free individuals with or without diabetes were used for comparison. Time trends were analysed. RESULTS: Amputations 41,304 were performed: 13,247 major and 28,057 minor. Five-year mortality rates in individuals with diabetes were 52% and 69% after minor and major LEA, respectively (individuals without diabetes: 45% and 63%, respectively). In the first six postoperative months, no differences in mortality rates were found between individuals with or without diabetes. Later, hazard ratios (HRs) for mortality in individuals with diabetes (compared with no diabetes) after minor LEA ranged from 1.38 to 1.52, and after major LEA from 1.35 to 1.46 (all p ≤ 0.005). Among individuals without LEA, HRs for mortality in diabetes (versus no diabetes) were systematically higher compared to the HRs for mortality in diabetes (versus no diabetes) after minor and major LEA. One-year survival rates did not change for individuals with diabetes. CONCLUSIONS: In the first six postoperative months, mortality rates after LEA were not different between individuals with or without diabetes; later, diabetes was significantly associated with increased mortality. However, as HRs for mortality were higher in amputation-free individuals, diabetes impacts mortality less in the minor and major amputation groups relative to the comparison group of individuals without LEA.

Health-related quality of life of people with type 1 diabetes: An IMI2 SOPHIA post hoc analysis of FUTURE and ADJUNCT-ONE.

AIM: To characterize and stratify health-related quality of life in individuals with type 1 diabetes (T1D) using body mass index (BMI) and clustering analysis. MATERIAL AND METHODS: Baseline data on individuals with T1D were pooled from two studies. A post hoc analysis of health-related quality of life, measured using the 36-item Short-Form questionnaire, was performed, referenced to the 2010 US general population. Descriptive statistics were presented for the pooled cohort and per BMI category. K-means clustering was performed. One-way analysis of variance was conducted to examine differences in clinical characteristics between clusters. RESULTS: The pooled cohort consisted of 2256 individuals with T1D (age: 45.4 ± 15.0 years, BMI: 26.2 ± 4.6 kg/m2, diabetes duration: 22.7 ± 13.5 years). All quality-of-life domains were slightly lower than 50(the general population's mean), except for vitality. Individuals with a BMI ≥30 kg/m2 reported lower scores for bodily pain, physical functioning, general health, and vitality. A first cluster with a high and a second cluster with a low quality of life were identified, with significant differences in the mental (Cluster 1: 53.8 ± 6.8 vs. Cluster 2: 39.5 ± 10.7; p < 0.001) and physical component summary scores (Cluster 1: 49.6 ± 6.3 vs. Cluster 2: 35.2 ± 12.0; p < 0.001), which exceeded differences found between BMI categories. CONCLUSIONS: In our population of people living with T1D, higher BMI may have adversely impacted physical domains of quality of life, but larger differences between the high- and low-quality-of-life cluster indicate that more factors play a role.

Evidence-based interventions for identifying candidate quality indicators to assess quality of care in diabetic foot clinics: a scoping review.

BACKGROUND: Foot ulcers in people with diabetes are a serious complication requiring a complex management and have a high societal impact. Quality monitoring systems to optimize diabetic foot care exist, but a formal and more evidence-based approach to develop quality indicators (QIs) is lacking. We aimed to identify a set of candidate indicators for diabetic foot care by adopting an evidence-based methodology. METHODS: A systematic search was conducted across four academic databases: PubMed, Embase CINAHL and Cochrane Library. Studies that reported evidence-based interventions related to organization or delivery of diabetic foot care were searched. Data from the eligible studies were summarized and used to formulate process and structure indicators. The evidence for each candidate QI was described in a methodical and transparent manner. The review process was reported according to the "Preferred Reported Items for Systematic reviews and Meta-Analysis" (PRISMA) statements and its extension for scoping reviews. RESULTS: In total, 981 full-text articles were screened, and 322 clinical studies were used to formulate 42 candidate QIs. CONCLUSIONS: An evidence-based approach could be used to select candidate indicators for diabetic foot ulcer care, relating to the following domains: wound healing interventions, peripheral artery disease, offloading, secondary prevention, and interventions related to organization of care. In a further step, the feasibility of the identified set of indicators will be assessed by a multidisciplinary panel of diabetic foot care stakeholders.

A multidisciplinary Delphi consensus to define evidence-based quality indicators for diabetic foot ulcer care.

BACKGROUND: Valid measures to assess quality of care delivered to patients with diabetes suffering from diabetic foot ulcer (DFU) are scarce. This study aimed to achieve consensus on relevant and feasible quality indicators (QIs) among stakeholders involved in DFU care and was conducted as the second part of a Belgian QI selection study that sought to identify QIs for DFU care. METHODS: A stakeholder panel, including caregivers from primary care and specialized disciplines active in diabetic foot care as well as a patient organization representative, was recruited. By using the RAND/UCLA Appropriateness Method, stakeholders were asked to rate a list of 42 candidate evidence-based indicators for appropriateness through a 9-point Likert scale. QIs were classified based on the median ratings and the disagreement index, calculated by the inter-percentile range adjusted for symmetry. RESULTS: At the end of a three-phase process, 17 QIs were judged as appropriate. Among them, five were not previously described, covering the following topics: integration of wound care specialty in the multidisciplinary team, systematic evaluation of the nutritional status of the patient, administration of low-density lipoprotein-cholesterol lowering medication and protocolized care (implementation of care and prevention management protocols). CONCLUSIONS: The identified evidence-based QIs provide an assessment tool to evaluate and monitor quality of care delivered to DFU patients. Future research should focus on their complementarity with the existing QIs and their implementation in clinical practice.

Closed-loop insulin delivery in pregnant women with type 1 diabetes (CRISTAL): a multicentre randomized controlled trial - study protocol.

BACKGROUND: Despite increasing use of continuous glucose monitoring (CGM) and continuous subcutaneous insulin infusion (CSII, insulin pumps) in type 1 diabetes (T1D) in pregnancy, achieving recommended pregnancy glycaemic targets (3.5-7.8 mmol/L or 63-140 mg/dL) remains challenging. Consequently, the risk of adverse pregnancy outcomes remains high. Outside pregnancy, hybrid closed-loop (HCL) insulin delivery systems have led to a paradigm shift in the management of T1D, with 12% higher time in glucose target range (TIR) compared to conventional CSII. However, most commercially available HCL systems are currently not approved for use in pregnancy. This study aims to evaluate the efficacy, safety and cost-effectiveness of the MiniMed™ 780G HCL system (Medtronic) in T1D in pregnancy. METHODS: In this international, open-label, randomized controlled trial (RCT), we will compare the MiniMed™ 780G HCL system to standard of care (SoC) in T1D in pregnancy. Women aged 18-45 years with T1D diagnosis of at least one year, HbA1c ≤ 86 mmol/mol (≤ 10%), and confirmed singleton pregnancy up to 11 weeks 6 days will be eligible. After providing written informed consent, all participants will wear a similar CGM system (Guardian™ 3 or Guardian™ 4 CGM) during a 10-day run-in phase. After the run-in phase, participants will be randomised 1:1 to 780G HCL (intervention) or SoC [control, continuation of current T1D treatment with multiple daily injections (MDI) or CSII and any type of CGM] stratified according to centre, baseline HbA1c (< 53 vs. ≥ 53 mmol/mol or < 7 vs. ≥ 7%), and method of insulin delivery (MDI or CSII). The primary outcome will be the time spent within the pregnancy glucose target range, as measured by the CGM at four time points in pregnancy: 14-17, 20-23, 26-29, and 33-36 weeks. Prespecified secondary outcomes will be overnight TIR, time below range (TBR: <3.5 mmol/L or < 63 mg/dL), and overnight TBR. Other outcomes will be exploratory. The planned sample size is 92 participants. The study will end after postpartum discharge from hospital. Analyses will be performed according to intention-to-treat as well as per protocol. DISCUSSION: This large RCT will evaluate a widely used commercially available HCL system in T1D in pregnancy. Recruitment began in January 2021 and was completed in October 2022. Study completion is expected in May 2023. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04520971. Registration date: August 20, 2020. https://clinicaltrials.gov/ct2/show/NCT04520971.

Comparing real-time and intermittently scanned continuous glucose monitoring in adults with type 1 diabetes (ALERTT1): a 6-month, prospective, multicentre, randomised controlled trial.

BACKGROUND: People with type 1 diabetes can continuously monitor their glucose levels on demand (intermittently scanned continuous glucose monitoring [isCGM]), or in real time (real-time continuous glucose monitoring [rtCGM]). However, it is unclear whether switching from isCGM to rtCGM with alert functionality offers additional benefits. Therefore, we did a trial comparing rtCGM and isCGM in adults with type 1 diabetes (ALERTT1). METHODS: We did a prospective, double-arm, parallel-group, multicentre, randomised controlled trial in six hospitals in Belgium. Adults with type 1 diabetes who previously used isCGM were randomly assigned (1:1) to rtCGM (intervention) or isCGM (control). Randomisation was done centrally using minimisation dependent on study centre, age, gender, glycated haemoglobin (HbA1c), time in range (sensor glucose 3·9-10·0 mmol/L), insulin administration method, and hypoglycaemia awareness. Participants, investigators, and study teams were not masked to group allocation. Primary endpoint was mean between-group difference in time in range after 6 months assessed in the intention-to-treat sample. This trial is registered with ClinicalTrials.gov, NCT03772600. FINDINGS: Between Jan 29 and Jul 30, 2019, 269 participants were recruited, of whom 254 were randomly assigned to rtCGM (n=127) or isCGM (n=127); 124 and 122 participants completed the study, respectively. After 6 months, time in range was higher with rtCGM than with isCGM (59·6% vs 51·9%; mean difference 6·85 percentage points [95% CI 4·36-9·34]; p<0·0001). After 6 months HbA1c was lower (7·1% vs 7·4%; p<0·0001), as was time <3·0 mmol/L (0·47% vs 0·84%; p=0·0070), and Hypoglycaemia Fear Survey version II worry subscale score (15·4 vs 18·0; p=0·0071). Fewer participants on rtCGM experienced severe hypoglycaemia (n=3 vs n=13; p=0·0082). Skin reaction was more frequently observed with isCGM and bleeding after sensor insertion was more frequently reported by rtCGM users. INTERPRETATION: In an unselected adult type 1 diabetes population, switching from isCGM to rtCGM significantly improved time in range after 6 months of treatment, implying that clinicians should consider rtCGM instead of isCGM to improve the health and quality of life of people with type 1 diabetes. FUNDING: Dexcom.

Positioning sulphonylureas in a modern treatment algorithm for patients with type 2 diabetes: Expert opinion from a European consensus panel.

The large number of pharmacological agents available to treat type 2 diabetes (T2D) makes choosing the optimal drug for any given patient a complex task. Because newer agents offer several advantages, whether and when sulphonylureas (SUs) should still be used to treat T2D is controversial. Published treatment guidelines and recommendations should govern the general approach to diabetes management. However, expert opinions can aid in better understanding local practices and in formulating individual choices. The current consensus paper aims to provide additional guidance on the use of SUs in T2D. We summarize current local treatment guidelines in European countries, showing that SUs are still widely proposed as second-line treatment after metformin and are often ranked at the same level as newer glucose-lowering medications. Strong evidence now shows that sodium-glucose co-transporter-2 inhibitors (SGLT-2is) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) are associated with low hypoglycaemia risk, promote weight loss, and exert a positive impact on vascular, cardiac and renal endpoints. Thus, using SUs in place of SGLT-2is and GLP-1RAs may deprive patients of key advantages and potentially important cardiorenal benefits. In subjects with ascertained cardiovascular disease or at very high cardiovascular risk, SGLT-2is and/or GLP-1RAs should be used as part of diabetes management, in the absence of contraindications. Routine utilization of SUs as second-line agents continues to be acceptable in resource-constrained settings.

Decreasing rates of major lower-extremity amputation in people with diabetes but not in those without: a nationwide study in Belgium.

AIMS/HYPOTHESIS: The reduction of major lower-extremity amputations (LEAs) is one of the main goals in diabetes care. Our aim was to estimate annual LEA rates in individuals with and without diabetes in Belgium, and corresponding time trends. METHODS: Data for 2009-2013 were provided by the Belgian national health insurance funds, covering more than 99% of the Belgian population (about 11 million people). We estimated the age-sex standardised annual amputation rate (first per year) in the populations with and without diabetes for major and minor LEAs, and the corresponding relative risks. To test for time trends, Poisson regression models were fitted. RESULTS: A total of 5438 individuals (52.1% with diabetes) underwent a major LEA, 2884 people with above- and 3070 with below-the-knee major amputations. A significant decline in the major amputation rate was observed in people with diabetes (2009: 42.3; 2013: 29.9 per 100,000 person-years, 8% annual reduction, p < 0.001), which was particularly evident for major amputations above the knee. The annual major amputation rate remained stable in individuals without diabetes (2009: 6.1 per 100,000 person-years; 2013: 6.0 per 100,000 person-years, p = 0.324) and thus the relative risk reduced from 6.9 to 5.0 (p < 0.001). A significant but weaker decrease was observed for minor amputation in individuals with and without diabetes (5% and 3% annual reduction, respectively, p < 0.001). CONCLUSIONS/INTERPRETATION: In this nationwide study, the risk of undergoing a major LEA in Belgium gradually declined for individuals with diabetes between 2009 and 2013. However, continued efforts should be made to further reduce the number of unnecessary amputations.

Accuracy and precision of flash glucose monitoring sensors inserted into the abdomen and upper thigh compared with the upper arm.

Nowadays, most Belgian patients with type 1 diabetes use flash glucose monitoring (FreeStyle Libre [FSL]; Abbott Diabetes Care, Alameda, California) to check their glucose values, but some patients find the sensor on the upper arm too visible. The aim of the present study was to compare the accuracy and precision of FSL sensors when placed on different sites. A total of 23 adults with type 1 diabetes used three FSL sensors simultaneously for 14 days on the upper arm, abdomen and upper thigh. FSL measurements were compared with capillary blood glucose (BG) measurements obtained with a built-in FSL BG meter. The aggregated mean absolute relative difference was 11.8 ± 12.0%, 18.5 ± 18.4% and 12.3 ± 13.8% for the arm, abdomen (P = .002 vs arm) and thigh (P = .5 vs arm), respectively. Results of Clarke error grid analysis for the arm and thigh were similar (zone A: 84.9% vs 84.5%; P = .6), while less accuracy was seen for the abdomen (zone A: 69.4%; P = .01). Apart from the first day, the accuracy of FSL sensors on the arm and thigh was more stable across the 14-day wear duration than accuracy of sensors on the abdomen, which deteriorated mainly during week 2 (P < .0005). The aggregated precision absolute relative difference was markedly lower for the arm/thigh (10.9 ± 11.9%) compared with the arm/abdomen (20.9 ± 22.8%; P = .002). Our results indicate that the accuracy and precision of FSL sensors placed on the upper thigh are similar to the upper arm, whereas the abdomen performed unacceptably poorly.

The German and Belgian accreditation models for diabetic foot services.

The International Working Group on the Diabetic Foot recommends that auditing should be part of the organization of diabetic foot care, the efforts required for data collection and analysis being balanced by the expected benefits. In Germany legislature demands measures of quality management for in- and out-patient facilities, and, in 2003, the Germany Working Group on the Diabetic Foot defined and developed a certification procedure for diabetic foot centres to be recognized as 'specialized'. This includes a description of management facilities, treatment procedures and outcomes, as well as the organization of mutual auditing visits between the centres. Outcome data is collected at baseline and 6 months on 30 consecutive patients. By 2014 almost 24,000 cases had been collected and analysed. Since 2005 Belgian multidisciplinary diabetic foot clinics could apply for recognition by health authorities. For continued recognition diabetic foot clinics need to treat at least 52 patients with a new foot problem (Wagner 2 or more or active Charcot foot) per annum. Baseline and 6-month outcome data of these patients are included in an audit-feedback initiative. Although originally fully independent of each other, the common goal of these two initiatives is quality improvement of national diabetic foot care, and hence exchanges between systems has commenced. In future, the German and Belgian accreditation models might serve as templates for comparable initiatives in other countries. Just recently the International Working Group on the Diabetic Foot initiated a working group for further discussion of accreditation and auditing models (International Working Group on the Diabetic Foot AB(B)A Working Group).

Clinical action measures improve the reliability of feedback on quality of care in diabetes centres: a retrospective cohort study.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Differences in pregnancy outcomes and characteristics between insulin- and diet-treated women with gestational diabetes.

BACKGROUND: Our aim was to evaluate the difference in pregnancy outcomes and characteristics between insulin- and diet-treated women with gestational diabetes (GDM). METHODS: 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. RESULTS: 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). CONCLUSION: 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.

Implementation of a quality improvement initiative in Belgian diabetic foot clinics: feasibility and initial results.

BACKGROUND: This article aims to describe the implementation and initial results of an audit-feedback quality improvement initiative in Belgian diabetic foot clinics. METHODS: Using self-developed software and questionnaires, diabetic foot clinics collected data in 2005, 2008 and 2011, covering characteristics, history and ulcer severity, management and outcome of the first 52 patients presenting with a Wagner grade ≥ 2 diabetic foot ulcer or acute neuropathic osteoarthropathy that year. Quality improvement was encouraged by meetings and by anonymous benchmarking of diabetic foot clinics. RESULTS: The first audit-feedback cycle was a pilot study. Subsequent audits, with a modified methodology, had increasing rates of participation and data completeness. Over 85% of diabetic foot clinics participated and 3372 unique patients were sampled between 2005 and 2011 (3312 with a diabetic foot ulcer and 111 with acute neuropathic osteoarthropathy). Median age was 70 years, median diabetes duration was 14 years and 64% were men. Of all diabetic foot ulcers, 51% were plantar and 29% were both ischaemic and deeply infected. Ulcer healing rate at 6 months significantly increased from 49% to 54% between 2008 and 2011. Management of diabetic foot ulcers varied between diabetic foot clinics: 88% of plantar mid-foot ulcers were off-loaded (P10-P90: 64-100%), and 42% of ischaemic limbs were revascularized (P10-P90: 22-69%) in 2011. CONCLUSIONS: A unique, nationwide quality improvement initiative was established among diabetic foot clinics, covering ulcer healing, lower limb amputation and many other aspects of diabetic foot care. Data completeness increased, thanks in part to questionnaire revision. Benchmarking remains challenging, given the many possible indicators and limited sample size. The optimized questionnaire allows future quality of care monitoring in diabetic foot clinics.

Nurse-led telecoaching of people with type 2 diabetes in primary care: rationale, design and baseline data of a randomized controlled trial.

BACKGROUND: 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. METHODS/DESIGN: Randomized controlled trial in patients with type 2 diabetes. Patients were selected based on their medication consumption data and were recruited by their sickness fund. They were randomized to receive either usual care plus "The COACH Program" or usual care alone. The study will assess the difference in outcomes between groups. The primary outcome measure is the level of HbA1c. The secondary outcomes are: Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, Blood Pressure, body mass index, smoking status; proportion of people at target for HbA1c, LDL-Cholesterol and Blood Pressure; self-perceived health status, diabetes-specific emotional distress and satisfaction with diabetes care. The follow-up period is 18 months. Within-trial and modeled cost-utility analyses, to project effects over life-time horizon beyond the trial duration, will be undertaken from the perspective of the health care system if the intervention is effective. DISCUSSION: The study will enhance our understanding of the potential of telehealth in diabetes management in Belgium. Research on the clinical effectiveness and the cost-effectiveness is essential to support policy makers in future reimbursement and implementation decisions.

Engaging GPs in insulin therapy initiation: a qualitative study evaluating a support program in the Belgian context.

BACKGROUND: A program supporting the initiation of insulin therapy in primary care was introduced in Belgium, as part of a larger quality improvement project on diabetes care. This paper reports on a study exploring factors influencing the engagement of general practitioners (GPs) in insulin therapy initiation (research question 1) and exploring factors relevant for future program development (research question 2). METHODS: We have used semi-structured interviews to answer the first research question: two focus group interviews with GPs who had at least one patient in the insulin initiation program and 20 one-to-one interviews with GPs who were not regular users of the overall support program in the region. To explore factors relevant for future program development, the data from the GPs were triangulated with data obtained from individual interviews with patients (n = 10), the diabetes nurse educator (DNE) and the specialist involved in the program, and data extracted from meeting reports evaluating the insulin initiation support program. RESULTS: We found differences between GPs engaged and those not engaged in insulin initiation in attitude, subjective norm and perceived behavioural control regarding insulin initiation. In general the support program was evaluated in a positive way by users of the program. Some aspects need further consideration: job boundaries between the DNE and GPs, job boundaries between GPs and specialists, protocol adherence and limited case load. CONCLUSION: The study shows that the transition of insulin initiation from secondary care to the primary care setting is a challenge. Although a support program addressing known barriers to insulin initiation was provided, a substantial number of GPs were reluctant to engage in this aspect of care. Important issues for future program development are: an interdisciplinary approach to job clarification, a dynamic approach to the integration of expertise in primary care and feedback on protocol adherence. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00824499.

Assessment of with sulfonylurea use in type 2 diabetes mellitus: A retrospective cohort study.

AIMS: The utilization of sulfonylurea (SU) for the management of Type 2 Diabetes Mellitus (T2DM) has witnessed a decline, attributed to the rising popularity of alternative medications and uncertainties surrounding the cardiovascular risk profile of SUs. This study aimed to investigate the potential association between SU intake and the incidence of cardiovascular events in patients with T2DM. METHODS: A retrospective cohort study, based on a general practice (GP) registry, was designed, encompassing patients diagnosed with T2DM between 2005 and 2014.Follow-up persisted until the occurrence of a cardiovascular event, loss to follow-up, or until December 31, 2022. Comparative analyses were conducted between patients, receiving SU treatment and those without RESULTS: Data from a cohort comprising 5589 patients revealed that 13 % and 13.1 % of individuals in the comparator group and the SU group, respectively, experienced a cardiovascular event. However, no statistically significant elevation in the risk of cardiovascular events was observed after SU usage. Furthermore, the glycated haemoglobin (HbA1c) levels were significantly higher in the SU group (7.0 % vs. 6.4 %, p < 0.001). CONCLUSIONS: The findings from this study indicate that the use of sulfonylureas SUs is not associated with a statistically significant increase in the risk of cardiovascular events among patients with type T2DM. These results contribute to the ongoing discourse on the safety and efficacy of SU therapy in diabetes management.

Evaluation of Glucose Metrics in Adults with Type 1 Diabetes Switching to Insulin Glargine 300 U/mL: A Retrospective, Propensity-Score Matched Study.

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.