Patient and provider acceptance of telecoaching in type 2 diabetes: a mixed-method study embedded in a randomised clinical trial.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: NCT01612520 , registered prior to recruitment on 4th June 2012.

Optimizing diabetes control in people with Type 2 diabetes through nurse-led telecoaching.

AIMS: To study the effect of a target-driven telecoaching intervention on HbA1c and other modifiable risk factors in people with Type 2 diabetes. METHODS: We conducted a randomized controlled trial in patients receiving hypoglycaemic agents. The primary outcome was HbA1c level at 6 months in the entire sample and in a subgroup with HbA1c levels ≥ 53 mmol/mol (7%) at baseline. Secondary outcomes were HbA1c at 18 months; total cholesterol, LDL, HDL, triglycerides, blood pressure, BMI and proportion of people who had achieved guideline-recommended targets at 6 and 18 months. RESULTS: A total of 287 participants were randomized to telecoaching and 287 to usual care. The mean (sd) baseline HbA1c level was 53 (11) mmol/mol [7.0 (1.0)%] overall and 63 (10) mmol/mol [7.9 (0.9)%] in the elevated HbA1c subgroup. At 6 months, the between-group differences in favour of telecoaching were: HbA1c -2 (95% CI -4; -1) mmol/mol [-0.2 (95% CI -0.3;-0.1)%; P=0.003] overall and -4 (95% CI -7; -2) mmol/mol [-0.4 (95% CI -0.7; -0.2)%; P=0.001] in the elevated HbA1c subgroup; BMI -0.4 kg/m(2) (95% CI -0.6; -0.1; P=0.003); total cholesterol -6 mg/dl (95% CI -11; -1, P=0.012). The proportion of participants on target for the composite of HbA1c , LDL and blood pressure increased by 8.9% in the intervention group and decreased by 1.3% in the control group (P=0.011). At 18 months, the difference in HbA1c was: -2 (95% CI -3;-0) mmol/mol [-0.2 (95% CI -0.3; -0.0)%; P=0.046] overall and -4 (-7; -1) mmol/mol [-0.4 (95% CI -0.7; -0.1)%; P=0.023] in the elevated HbA1c subgroup. CONCLUSION: Nurse-led telecoaching improved glycaemic control, total cholesterol levels and BMI in people with Type 2 diabetes. Twelve months after the intervention completion, there were sustained improvements in glycaemic control.

[INITIATING AND INTENSIFYING INSULIN THERAPY IN GENERAL PRACTICE: INSUSTAR, AN OBSERVATIONAL BELGIAN PROSPECTIVE STUDY IN TYPE 2 DIABETES]. / Instauration et optimization d'une insulinothérapie en médicine générale: InsuStar, une etude observationnelle prospective belge dans le diabete de type 2.

Initiating or intensifying insulin therapy is often considered as a challenge in general practice. The observational prospective Belgian study InsuStar was performed in 2011-2013 among 150 representative general practitioners, who were invited to initiate or intensify insulin therapy when necessary in 523 patients with type 2 diabetes (mean age: 65.5 years; mean HbAk: 8.8%). The initiation of insulin therapy (glargine in > 50%) was justified by insufficient glycaemic control (96%) and its intensification (replacement of insulin NPH or premixed insulins by insulin glargine, eventually with the addition of a short-acting insulin analogue) aimed at improving glucose control (58%), avoiding hypoglycaemia (17%) or both (17%). After a follow up of 6:1 months, HbAlc level decreased from 8.79% to 7.52% (-1.27%; 95% confidence interval: -1.43, -1.11; p<0.001). Overall 27.6% of patients reached an HbAl, < 7% versus 5.9% at inclusion (p<0.001), with rather few hypoglycaemia and a high physi- cian confidence level regarding insulin therapy. These results should encourage general practitioners to initiate insulin therapy at an earlier stage and to intensify it when necessary in patients with insufficiently controlled type 2 diabetes.

Review of clinical approaches and diagnostic quantities used in pedobarographic measurements.

The non-invasive nature of pedobarographic measurements is particularly attractive to researchers for analyzing and characterizing the impact of specific pathological foot conditions. However, adequate clinical use of pedobarographic technology requires a profound technical and methodological knowledge. Several papers summarized the technical capacities of pedobarographic technology. Moreover, methodological expertise has grown considerably during the last two decades. Therefore, two crucial decisions have to be made before pathomechanical modelling or functional interpretation of foot and lower limb disorders can be pursued. The first is the selection of the specific method to analyse the dynamic plantar footprint, and the second is the choice of parameters to quantify the results. In the first part of this paper, we review the different methods used to analyse the dynamic plantar footprint and discuss their conceptual backgrounds. We also aim to illustrate the clinical relevance of each method and elaborate on the future perspectives. In the second part, we review quantification methods of pedobarographic measurements. The latter is of primary relevance to clinicians and investigators with a special interest in foot and lower limb biomechanics.

Comparison of foot segmental mobility and coupling during gait between patients with diabetes mellitus with and without neuropathy and adults without diabetes.

BACKGROUND: Reduction in foot mobility has been identified as a key factor of altered foot biomechanics in individuals with diabetes mellitus. This study aimed at comparing in vivo segmental foot kinematics and coupling in patients with diabetes with and without neuropathy to control adults. METHODS: Foot mobility of 13 diabetic patients with neuropathy, 13 diabetic patients without neuropathy and 13 non-diabetic persons was measured using an integrated measurement set-up including a plantar pressure platform and 3D motion analysis system. In this age-, sex- and walking speed matched comparative study; differences in range of motion quantified with the Rizzoli multisegment foot model throughout different phases of the gait cycle were analysed using one-way repeated measures analysis of variance (ANOVA). Coupling was assessed with cross-correlation techniques. FINDINGS: Both cohorts with diabetes showed significantly lower motion values as compared to the control group. Transverse and sagittal plane motion was predominantly affected with often lower range of motion values found in the group with neuropathy compared to the diabetes group without neuropathy. Most significant changes were observed during propulsion (both diabetic groups) and swing phase (predominantly diabetic neuropathic group). A trend of lower cross-correlations between segments was observed in the cohorts with diabetes. INTERPRETATION: Our findings suggest an alteration in segmental kinematics and coupling during walking in diabetic patients with and without neuropathy. Future studies should integrate other biomechanical measurements as it is believed to provide additional insight into neural and mechanical deficits associated to the foot in diabetes.

Organization of a quality-assurance project in all Belgian multidisciplinary diabetes centres treating insulin-treated diabetes patients: 5 years' experience.

AIMS: To describe the IQED, a quality-assurance system started in 2001 in Belgian hospital-based multidisciplinary diabetes centres, and its effects on the quality of care. METHODS: The study was conducted through four data collections (in 2001, 2002, 2004 and 2006). Approximately 120 diabetes centres provided data on a systematic random sample of 10% of their adult diabetic patients on at least two daily insulin injections. Data on patient characteristics, glycaemic control, cardiovascular risk, diabetes complications, follow-up procedures and treatment were obtained. Local quality promotion was encouraged by returning comprehensive feedback (benchmarks) and during information meetings. RESULTS: Nearly all diabetes centres (98-100%) participated. The pooled sample consisted of 9194 (32%) Type 1 and 19 828 (68%) Type 2 diabetes patients, with mean diabetes duration of 17 years and 14 years, prevalence of microvascular complications of 23% and 38% and prevalence of macrovascular complications of 9% and 26%, respectively. At the start, the quality of care was good in terms of risk-factor testing rates and moderate in terms of patients meeting goals for risk-factor management. At least 50% of the centres initiated quality-promoting initiatives. After 5 years, significant improvements were seen in risk-factor testing rates, apart from renal screening. Improvements in intermediate outcomes were less obvious, apart from an increase in patients reaching the targets for blood pressure and LDL cholesterol. CONCLUSIONS: It is feasible to implement a continuous quality-improvement project on a nationwide scale, with improvements particularly in process indicators.

[Initiave to promote quality of care and epidemiology of diabetes mellitus]. / L'initiative pour la promotion de la qualite et epidemiologie du diabete sucre (IPQED).

Since 2001, the "Diabetes Convention Centres" in Belgium participated to a survey, called IPQED ("Initiative for the Promotion of Quality and Epidemiology of Diabetes mellitus), every 12-18 months. This project aims at systematically and anonymously collecting a limited but significant set of data (anamnesis, clinical examination, clinical chemistry: according to DiabCare) in a large sample (about 10%) of type 1 or type 2 diabetic patients followed in the Diabetes Convention Centres (inclusion criteria: at least two injections of insulin per day). IPQED has three main objectives: 1) to optimise the quality of care using a benchmarking process and the creation of quality circles; 2) to provide to health authorities some general advise concerning care for diabetic patients, in general, and in the Convention Diabetes Centres, in particular; and 3) to collect Belgian data among a large cohort of diabetic patients (around 8.000 per survey) that could be used for epidemiological studies.

[The role of diabetes convention centres in Belgium]. / Le rôle des centres de convention du diabète en Belgique.

We briefly present the modes of functioning of Diabetes Convention Centres in Belgium. In those hospital centres, patients with both type 1 or type 2 diabetes, treated by at least two insulin injections per day, benefit of an intensive educational programme by a multidisciplinary team and receive free of charge material for home blood glucose monitoring, in order to optimize diabetes management. The collaboration between convention centres and general practitioners should be reinforced (share-care), especially to improve the management of type 2 diabetic patients, who are increasingly treated with various insulin regimens.

Feasibility of a quality assurance programme of bedside blood glucose testing in a hospital setting: 7 years' experience.

AIMS: Description of the long-term use of a quality assurance (QA) programme for bedside capillary blood glucose (CBG) testing in a general hospital. METHODS: The main points of the programme were selection of instrumentation using a standardized testing procedure, design and implementation of a quality control (QC) procedure, and training and motivation of nurses. The QC procedures consisted of a daily aqueous control and a weekly split-sample control (a measurement on a capillary blood sample using the glucose meter and on a simultaneously drawn venous sample with the laboratory analyser). When the result was out of range, a laboratory technician visited the ward to investigate the problem. All wards received a weekly report. RESULTS: The programme was introduced in 1995 and followed up through 2002. The split-sample control was more efficient in detecting clinically relevant errors than the aqueous control. Most errors (91-97%) were operator-related rather than instrument-related. The compliance with the split-sample controls remained high, with 84-91% of weekly controls performed over 7 years. Respectively 91, 95 and 96% of the measurements remained within the range of +/- 20% of the laboratory value in the years 2000, 2001 and 2002. CONCLUSION: A QA programme of bedside CBG testing can successfully be implemented. It is feasible to obtain a satisfying level of measurement accuracy and to maintain a high level of compliance with the programme over several years. Split-sample controls are an essential part of the control procedure.

Neuroendocrine tumor markers.

Tumor markers used in the diagnosis and follow-up of patients with neuroendocrine tumors are in most instances not specific for a given tumor and circulate under normal conditions in the serum, making their use as an early diagnostic tool difficult (low sensitivity). By combining hormone measurements with tissue responsiveness, demonstrations of inappropriate secretions of PTH, insulin, and gastrin during hypercalcemia, hypoglycemia, and hyperacidity, respectively, become highly sensitive and specific diagnostic tests. The application of polyclonal antibodies in RIAs of hormones, such as ACTH, insulin, and gastrin, increase the diagnostic level of hormone measurements in patients with neuroendocrine tumors. Other markers, such as chromogranin A, neuron-specific enolase, and alpha-subunit, as well as peptide receptor visualization, are of increasing importance in the diagnosis and follow-up of neuroendocrine and non-neuroendocrine tumors.

Long-term treatment with the dopamine agonist quinagolide of patients with clinically non-functioning pituitary adenoma.

OBJECTIVE: This study was performed to evaluate the effect of prolonged treatment with the dopamine agonist quinagolide on serum gonadotropin and alpha-subunit concentrations and tumor volume in patients with clinically non-functioning pituitary adenomas (CNPA). DESIGN: Ten patients with CNPA were treated with quinagolide (0.3 mg daily). The median duration of treatment was 57 months (range 36-93 months). Blood samples for measurement of serum gonadotropin and alpha-subunit concentrations were drawn before treatment, after 5 days, and at each outpatient visit. Computerized tomography or magnetic resonance imaging of the pituitary region and Goldmann perimetry were done before and at regular intervals during treatment. RESULTS: A significant decrease of serum FSH, LH or alpha-subunit concentrations was found in nine patients. The levels remained low during the entire treatment period. In two out of three patients with pre-existing visual field defects a slight improvement was shown during the first months of treatment, but eventually deterioration occurred in all three patients. A fourth patient developed unilateral ophthalmoplegia during treatment. During the first year tumor volume decreased in three patients, but in two of them regrowth occurred after a few months. In six patients progressive tumor growth occurred despite sustained suppression of gonadotropin or alpha-subunit levels. CONCLUSIONS: Long-term treatment of patients with CNPA with high doses of the dopamine agonist quinagolide could not prevent progressive increase in tumor size in most patients. It remains unproven whether quinagolide retards CNPA growth. Additional studies are needed to investigate whether subgroups of patients, e.g. those with positive dopamine receptor scintigraphy or those with marked hypersecretion of intact gonadotropins or subunits, will respond more favorably to treatment with dopamine agonists.

Chromogranin A: its clinical value as marker of neuroendocrine tumours.

Chromogranin A (CgA) belongs to a family of secretory proteins that are present in densecore vesicles of neuroendocrine cells. Owing to its widespread distribution in neuroendocrine tissues, it can be used as an excellent immunohistochemical marker of neoplasms of neuroendocrine origin. It can also serve as serum marker of neuroendocrine activity because it is co-released with the peptide hormone content of the secretory granules. The serum concentration of CgA is elevated in patients with various neuroendocrine tumours. Elevated levels are strongly correlated with tumour volume. Although its sensitivity and specificity cannot compete with that of the specific hormonal secretion products of most of these tumours, it can nevertheless have useful clinical applications. Neuroendocrine tumours for which no peptide marker is available usually retain the capacity to secrete CgA. CgA can thus be used as serum marker for these so-called 'non-functioning' endocrine tumours. Moreover, in patients with carcinoids and phaeochromocytomas, CgA is a more stable and thus more easily manageable marker than plasma levels of respectively serotonin and catecholamines and their urinary metabolites. Its role as an important general neuroendocrine marker may be extended in the future by the development of immunoscintigraphy of membrane-bound CgA, allowing in vivo visualization of neuroendocrine neoplasms.

Cabergoline in the treatment of acromegaly: a study in 64 patients.

Cabergoline is a new, long acting, dopamine agonist that is more effective and better tolerated than bromocriptine in patients with hyperprolactinemia. Because dopamine agonists still have a place in the medical management of acromegaly, cabergoline might be a useful treatment. We, therefore, evaluated the effect of long term administration of cabergoline in a large group of unselected acromegalic patients. Sixty-four patients were included in a multicenter, prospective, open labeled study. A subgroup of 16 patients had GH-/PRL-cosecreting pituitary adenomas. Cabergoline was started at a dose of 1.0 mg/week and was gradually increased until normalization of plasma insulin-like growth factor I (IGF-I) levels, occurrence of unacceptable side-effects, or a maximal weekly dose of 3.5 mg (7.0 mg in 1 case) was reached. Treatment with cabergoline suppressed plasma IGF-I below 300 micrograms/L in 39% of cases and between 300-450 micrograms/L in another 28%. With pretreatment plasma IGF-I concentrations less than 750 micrograms/L, a suppression of IGF-I below 300 micrograms/L was obtained in 53% of cases, and a suppression between 300-450 micrograms/L was obtained in another 32%. By contrast, with pretreatment plasma IGF-I concentrations above 750 micrograms/L, only 17% of cases showed a suppression of IGF-I below 300 micrograms/L, and there was IGF-I suppression between 300-450 micrograms/L in another 21%. In GH-/PRL-cosecreting adenomas, 50% of cases suppressed plasma IGF-I levels below 300 micrograms/L, and another 31% did so between 300-450 micrograms/L, in contrast to only 35% and 27%, respectively in GH-secreting adenomas. Similar results were obtained concerning the secretion of GH. Tumor shrinkage was demonstrated in 13 of 21 patients, with a mass reduction by more than half in 5 GH-/PRL-cosecreting adenomas. Except for slight gastrointestinal discomfort and orthostatic hypotension in a few patients at the beginning of therapy, cabergoline treatment was well tolerated. Only 2 patients stopped medication because of nausea. The weekly dose of cabergoline ranged between 1.0-1.75 mg. A further increase in the dose was only effective in 1 GH-/PRL-cosecreting adenoma. The results of this study suggest that cabergoline is an effective, well tolerated therapy that should be considered in the management of acromegaly, especially if the pituitary adenoma cosecretes GH and PRL or if pretreatment plasma IGF-I levels are below 750 micrograms/L.

Chromogranin A as serum marker for neuroendocrine neoplasia: comparison with neuron-specific enolase and the alpha-subunit of glycoprotein hormones.

Chromogranin A (CgA) is gaining acceptance as a serum marker of neuroendocrine tumors. Its specificity in differentiating between neuroendocrine and nonneuroendocrine tumors, its sensitivity to detect small tumors, and its clinical value, compared with other neuroendocrine markers, have not clearly been defined, however. The objectives of this study were to evaluate the clinical usefulness of CgA as neuroendocrine serum marker. Serum levels of CgA, neuron-specific enolase (NSE), and the alpha-subunit of glycoprotein hormones (alpha-SU) were determined in 211 patients with neuroendocrine tumors and 180 control subjects with nonendocrine tumors. The concentrations of CgA, NSE, and alpha-SU were elevated in 50%, 43%, and 24% of patients with neuroendocrine tumors, respectively. Serum CgA was most frequently increased in subjects with gastrinomas (100%), pheochromocytomas (89%), carcinoid tumors (80%), nonfunctioning tumors of the endocrine pancreas (69%), and medullary thyroid carcinomas (50%). The highest levels were observed in subjects with carcinoid tumors. NSE was most frequently elevated in patients with small cell lung carcinoma (74%), and alpha-SU was most frequently elevated in patients with carcinoid tumors (39%). Most subjects with elevated alpha-SU levels also had elevated CgA concentrations. A significant positive relationship was demonstrated between the tumor load and serum CgA levels (P < 0.01, by chi 2 test). Elevated concentrations of CgA, NSE, and alpha-SU were present in, respectively, 7%, 35%, and 15% of control subjects. Markedly elevated serum levels of CgA, exceeding 300 micrograms/L, were observed in only 2% of control patients (n = 3) compared to 40% of patients with neuroendocrine tumors (n = 76). We conclude that CgA is the best general neuroendocrine serum marker available. It has the highest specificity for the detection of neuroendocrine tumors compared to the other neuroendocrine markers, NSE and alpha-SU. Elevated levels are strongly correlated with tumor volume; therefore, small tumors may go undetected. Although its specificity cannot compete with that of the specific hormonal secretion products of most neuroendocrine tumors, it can have useful clinical applications in subjects with neuroendocrine tumors for whom either no marker is available or the marker is inconvenient for routine clinical use.

In vivo imaging of pituitary tumours using a radiolabelled dopamine D2 receptor radioligand.

OBJECTIVE: Knowledge of the dopamine D2 receptor status of pituitary tumours may play a predictive role in differential diagnosis and therapeutic decisions. This study was performed to evaluate the value of pituitary dopamine D2 receptor scintigraphy with (S)-2-hydroxy-3-123I-iodo-6-methoxy-N-[(1-ethyl-2-pyrrolidinyl) methyl]benzamide (123I-IBZM) in the diagnostic evaluation of patients with pituitary tumours. DESIGN AND PATIENTS: Scintigraphy using 123I-IBZM was performed in 5 patients with PRL-secreting macroadenomas, 2 patients with PRL-secreting microadenomas, 17 patients with clinically non-functioning pituitary adenomas (NFPAs), 12 patients with GH-secreting adenomas and 1 patient with a TSH-secreting macroadenoma. RESULTS: Single-photon emission tomography (SPECT) showed significant uptake of 123I-IBZM in the pituitary region in 3/5 macroprolactinoma patients. These results closely correlated with the response of plasma PRL levels to the dopamine D2 receptor agonist quinagolide. In two scan-positive prolactinoma patients, repeated SPECTs during therapy with quinagolide showed a reduction in the pituitary uptake of 123I-IBZM. Pituitary SPECT was negative in the 2 microprolactinoma patients, who responded to quinagolide administration. In 4/17 patients with NFPA, significant uptake of the radioligand in the pituitary region was observed. In 2/3 scan-positive NFPA patients, who were treated with quinagolide, shrinkage of the pituitary tumours was observed. Treatment with quinagolide resulted in stabilization of tumour growth in the other scan-positive patients. Four out of 17 patients with NFPA and a negative SPECT were treated with quinagolide. Tumour growth was observed in 1 patient, and tumour size did not change in the other 3 patients. The pituitary region of none of the 12 acromegaly patients showed significant uptake of 123I-IBZM. Sensitivity of the GH-secreting adenomas to quinagolide was demonstrated in 8/12 patients in vivo by an acute test, and in 6/9 of the tumours in vitro. Pituitary SPECT was negative in the patient with the TSH-secreting macroadenoma and this tumour also showed no sensitivity to quinagolide in vivo or in vitro. CONCLUSIONS: We conclude that 123I-IBZM is a ligand for in vivo imaging of dopamine agonist- sensitive macroprolactinomas, but not for microprolactinomas or GH-secreting adenomas. The technique potentially provides a means of predicting the dopamine agonist-responses of non-functioning pituitary adenomas in vivo.