Characteristics of new patient referrals to specialised diabetic foot units across Europe and factors influencing delays.

OBJECTIVE: Foot ulcers are a common complication of diabetes and are associated with an increase in lower limb amputation and death. Early referral to a specialised unit is recommended. The aim of this study was to assess the characteristics of new-patient referrals to specialised diabetes foot care units across Europe and to determine the factors involved in delayed referral. METHOD: In this prospective observational study, consecutive patients with a new foot ulcer presenting to nine diabetic foot centres in five European countries (France, Germany, Italy, Spain and the UK) were included. RESULTS: Some 25% of the 332 patients included had presented with a foot ulcer >3 months before referral to the participating foot clinic. Compared with patients referred earlier, patients with a long time to referral (>3 months) were older (p=0.006) and had a less severe wound according to Infectious Diseases Society of America (IDSA) classification (p=0.003) and University of Texas classification (grade D=infection + peripheral artery disease, p=0.004). CONCLUSION: The proportion of patients with a diabetic foot ulcer (DFU) referred to a specialised unit >3 months after the beginning of the ulcer remained high throughout Europe. Patients with severe DFU were, however, referred more quickly by front line health professionals. Primary care professionals need to be made aware of the importance of early referral to a specialised unit in order to improve the management of foot disease in patients with diabetes. DECLARATION OF INTEREST: The authors have no conflicts of interest to declare.

Effectiveness of fast-track pathway for diabetic foot ulcerations.

AIM: To investigate the effectiveness of fast-track pathway (FTP) in the management of diabetic foot ulceration (DFU) after 2 years of implementation. METHODS: The study group was composed of patients who referred to a specialized DF centre due to DFUs. Those were divided in two groups: early referral (ER) and late referral (LR) patients. According to FTP, ER were considered patients who referred after 2 weeks in the case of uncomplicated non-healing ulcers (superficial, not infected, not ischemic), within 4 days in the case of complicated ulcers (ischemic, deep, mild infection) and within 24 h in the case of severely complicated ulcers (abscess, wet gangrene, fever). Healing, healing time, minor and major amputation, hospitalization, and survival were evaluated. The follow-up was 6 months. RESULTS: Two hundred patients were recruited. The mean age was 70 ± 13 years, 62.5% were male, 91% were affected by type 2 diabetes with a mean duration of 18 ± 11 years. Within the group, 79.5% had ER while 20.5% had LR. ER patients showed increased rates of healing (89.9 vs. 41.5%, p = 0.001), reduced healing time (10 vs. 16 weeks, p = 0.0002), lower rates of minor (17.6 vs. 75.6%, p < 0.0001) and major amputation (0.6 vs. 36.6%, p < 0.0001), hospitalization (47.1 vs. 82.9%, p = 0.001), and mortality (4.4 vs. 19.5%, p = 0.02) in comparison to LR. At multivariate analysis, ER was an independent predictor of healing, while LR was an independent predictor for minor and major amputation and hospitalization. CONCLUSION: After the FTP implementation, less cases of LR were reported in comparison to ER. ER was an independent predictor of positive outcomes such as healing, healing time, limb salvage, hospitalization, and survival.

Ultrasonic-assisted wound debridement: report from a closed panel meeting.

Mechanical debridement can be considered as an alternative to surgical debridement if surgery is not available, or is considered impractical or too high risk. One form of selective mechanical debridement is ultrasonic-assisted wound (UAW) debridement. As the published evidence on this is limited, a closed international expert meeting was held to review the existing evidence base on it, present preliminary findings of research currently in progress and discuss individual cases selected from the clinical experts' own practice. The panel also explored the potential barriers to the implementation of UAW debridement and how these might be addressed. It concluded there is sufficient evidence that UAW debridement is an effective method of cleansing and debriding almost all hard-to-heal wounds. Patients who are most likely to benefit from it are not medically stable, on anticoagulants, unable to visit a hospital for wound treatment, and/or have wounds with a poor vascular supply or are close to critical structures. The panel also observed that UAW debridement can be used to prepare the wound for negative pressure wound therapy (NPWT) or as an adjunctive to it. Given the potential to experience pain during the procedure, the panel considered that patients will benefit from topical analgesia. The panel noted that health professionals, patients and visitors must be protected from the aerosolisation associated with UAW, to reduce risk of cross-contamination.

Referral of patients with diabetic foot ulcers in four European countries: patient follow-up after first GP visit.

OBJECTIVE: This study aimed to analyse the characteristics of patients, including demographics, medical history and treatment, with a diabetic foot ulcer (DFU) during their first follow-up visit to a general practitioner (GP). METHODS: A two-part quantitative online questionnaire was distributed among GPs in France, UK, Germany and Spain. Part one entailed a survey of GPs' perceptions of referrals for DFU. Part two collected data on recently managed DFU cases. The percentage of responses was compared for each question and across the four countries for significant differences. RESULTS: In part one of the study, 600 questionnaires were collected (150 per country) and 1188 patients managed for a DFU were included in the second part. About 88% of patients had type 2 diabetes, with a significant proportion of suboptimal control (average HbA1c: 10.64mmol/l). A patient complaint led to diagnosis in 60% of the cases. Wounds were found to be more frequently located in the toes and midfoot, and were superficial (according to the Texas Wound Classification system) in 80% of the cases. More than two-thirds of patients developed small wounds (<5cm2); more than half of them had infected wounds. Approximately 50% of wounds were ischaemic, which triggered the onset of a DFU. Follow-up wound examinations before and after hospitalisation were performed by nurses, except in Germany where GPs undertook this role, including prescribing offloading devices and in the UK where follow-up was managed by podiatrists. Ischaemia, wound necrosis, suspected osteomyelitis and absence of wound healing were the primary reasons for hospital admission during the first month after diagnosis. CONCLUSION: Delay in specialised foot care is a recurring topic in the treatment of DFUs, even with different health-care structures across Europe. Knowledge and education on DFUs should be reinforced among GPs and nurses to establish a global DFU care network between primary and specialised care, avoid hospitalisation and adequately manage high-risk patients.

Optimal wound closure of diabetic foot ulcers with early initiation of TLC-NOSF treatment: post-hoc analysis of Explorer.

OBJECTIVE: In March 2018, the Explorer study, an international, double-blind, randomised controlled trial (RCT), established that adding a TLC-NOSF (UrgoStart Contact, Laboratoires Urgo, France) dressing to good local standard of care (SoC) significantly and substantially increases wound closure and reduces the healing time of neuroischaemic diabetic foot ulcers (DFU). Besides the TLC-NOSF treatment, the wound duration was the only other covariate that had an influence on the wound closure rate in the regression model used in the original study. The purpose of this work was to further document the impact of wound duration on the healing outcomes of the DFUs included in the Explorer study and to discuss complementary pragmatic observations on the TLC-NOSF effect. METHOD: In this post-hoc analysis of the Explorer data, the wound closure rates by week 20 are reported for the global cohort (n=240, Intention-to-treat population) and for the treated (n=126) and control groups (n=114) according to DFU duration and location. RESULTS: For the combined group, wound closure rates decreased with the increase of wound duration at baseline (from 57% in wounds ≤2 months to 19% in wounds >11 months). Whatever the wound duration subgroups analysed, higher closure rates were reported in the TLC-NOSF group than in the control group. However, the maximal difference between the two treatments was reported in wounds with a duration of ≤2 months (71% versus 41%, 30 percentage points difference, Relative Risk 1.7, 95% Confidence Interval 1.1 to 2.8). Regarding wound location subgroup analyses, the outcomes were always in favour of the TLC-NOSF treatment, with closure rates ranging between 43% and 61% within the TLC-NOSF group, and between 25% and 40% within the control group. CONCLUSION: This clinical evidence supports that treating DFUs with TLC-NOSF dressing and good SoC results in higher wound closure rates than with a neutral dressing and the same good standard of care, whatever the duration and the location of the treated wounds. However, the earlier the TLC-NOSF dressing is initiated in DFU treatment, the greater the benefits.

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.

Perception of diabetic foot ulcers among general practitioners in four European countries: knowledge, skills and urgency.

OBJECTIVE: Diabetic foot ulcers (DFU) have the potential to deteriorate rapidly, in the absence of prompt assessment and treatment. The aim of this study was to analyse the awareness and perception of DFU among general practitioners (GPs) from four European countries, and to find possible differences between these countries in terms of management. METHOD: A two-part, quantitative, online questionnaire was distributed to GPs across four countries in Europe-the UK, France, Germany and Spain. The first part entailed a survey on the perception and knowledge of the pathogenesis and management of DFU, among GPs. The second part of the questionnaire was used for the collection of data on recently-managed DFU cases. RESULTS: For the first part of the study, 600 questionnaires were collected (150 per country) and 1188 patient cases of DFU management were included in the second part. In France, only 49% of GPs mentioned neuropathy as the main causative process in DFU development. However, in Germany and the UK, 82% and 83% of GPs, respectively, considered neuropathy as an important causative factor. DFU care in Spain and the UK is thought to be organised by multidisciplinary teams (MDT) (83% and 84% of GPs, respectively, completely agreed with this statement). In France and Germany, GPs are responsible for follow-up and management. Only UK physicians have clearly identified specialised podiatrists to refer patients to, if needed. Approximately 29-40% of GPs in all countries did not feel they were sufficiently trained in the DFU treatment protocol. Almost 30% of GPs in France and Germany thought that DFU treatment was not well-established due to the absence of clinical guidelines and protocols. CONCLUSION: The intra-country and inter-country management of the complex aspects of DFU is quite heterogeneous. The cause of this finding is multifactorial. Although there are international guidelines, it would be beneficial to establish clear and specific competencies for the different health professionals involved in DFU management. As a minimum, intra-country heterogeneity should improve with their development.

Delayed referral of patients with diabetic foot ulcers across Europe: patterns between primary care and specialised units.

OBJECTIVE: Diabetic foot ulceration (DFU) has the potential to deteriorate rapidly without prompt assessment and treatment. The aim of this study was to assess the referral patterns for DFU, from primary care to specialised diabetes foot care units. METHOD: A two-part, quantitative, online questionnaire was administered to GPs across four countries in Europe: France, the UK, Germany and Spain. The first part entailed a survey of GPs' perceptions of referrals for DFU. The second part of the questionnaire collected data on recently managed DFU cases. RESULTS: There were 600 questionnaires collected in the first part of the study (150 per country), and 1188 patient cases of DFU management were included in the second part. Up to 95% of patients had type 2 diabetes. Patients' complaints led to diagnosis, on average, 60% of the time, and the diagnosis was an incidental finding during a consultation 13-28% of the time. On average, only 40% of GPs completely agreed that they have clearly identified DFU clinical practitioners working in a hospital facility. In 55-66% of cases, the duration of DFU was unknown or DFU diagnosis was delayed more than three weeks from the onset of the wound. On average, 48% of patients were referred after an unknown duration or more than one month from the onset of DFU. CONCLUSION: Despite differences in health-care structures across Europe, delays in referral to specialist foot care teams seems to be a common theme. There is an ongoing need to educate GPs, nurses and patients to be more aware of the risk of DFU, and the need for prompt referral to specialist diabetic foot teams.

The effect of text message support on diabetes self-management in developing countries - A randomised trial.

OBJECTIVE: mHealth interventions have the potential to facilitate self-management. This TEXT4DSM study implemented a mobile phone intervention in existing diabetes programmes in three low- and middle-income countries (Democratic Republic of Congo, Cambodia, and the Philippines). RESEARCH DESIGN AND METHODS: Sub-studies with a similar randomised controlled trial design were conducted in three different countries. Each sub-study included 480 adults with diabetes. Subjects were randomised to receive either routine care or routine care plus text message self-management support. The primary outcome was the difference in the proportion of subjects with well-controlled diabetes after 2 years. RESULTS: Baseline and 2-year HbA1c measurements were available for 781 individuals. After 2 years, the proportion of subjects with controlled HbA1c was 2.8% higher in the intervention group than in the control group (difference not statistically significant). In the logistic regression model, the odds ratio for having controlled diabetes after the intervention was 1.1, after adjusting for baseline HbA1c level, sex, receiving insulin treatment, and participating in the routine programme. The HbA1c dynamics over time differed between programmes; the number of people with controlled diabetes tended to increase in DR Congo and decrease in Cambodia. CONCLUSION: This study was the first to test the same mHealth intervention in different countries. The finding that text messages did not show an additional effect on diabetes control implied that expectations about mHealth should be cautious. The degree of coverage, the quality of the routine programme, and the progression of disease can interfere with the expected impact. Trial registration: ISRCTN registry (86247213).

Incidence of lower extremity amputations in the diabetic compared with the non-diabetic population: A systematic review.

SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD4201501780.

Diabetic complications do not hamper improvement of health-related quality of life over the course of treatment of diabetic foot ulcers - the Eurodiale study.

AIMS: Diabetic complications, and in particular diabetic foot ulcers (DFUs), are associated with low health-related quality of life (HRQoL). We evaluated whether the presence of diabetic complications also influenced the improvement of HRQoL during DFU treatment. METHODS: 1088 patients presenting for DFU treatment at the centers participating in the Eurodiale study were followed prospectively up to one year. HRQoL was measured both at presentation and after healing or at end of follow up, using EQ-5D: a standardized instrument consisting of five domains and a summary index. The influence of diabetic comorbidity on the course of HRQoL was evaluated for each of the EQ-5D outcomes in multi-level linear regression analyses, adjusting for baseline characteristics. RESULTS: HRQoL improved in all EQ-5D outcomes over the course of treatment for those DFUs that healed. The few significant differences in the development of HRQoL between patients with and without comorbidity showed a more beneficial development for patients with comorbidity in DFUs that did not heal or healed slowly. CONCLUSIONS: Comorbidity does not hamper improvement of HRQoL in DFU treatment. On the contrary, HRQoL improved sometimes more in patients with certain comorbidity with hard-to-heal ulcers.

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).

Predictors of lower-extremity amputation in patients with an infected diabetic foot ulcer.

OBJECTIVE: Infection commonly complicates diabetic foot ulcers and is associated with a poor outcome. In a cohort of individuals with an infected diabetic foot ulcer, we aimed to determine independent predictors of lower-extremity amputation and the predictive value for amputation of the International Working Group on the Diabetic Foot (IWGDF) classification system and to develop a risk score for predicting amputation. RESEARCH DESIGN AND METHODS: We prospectively studied 575 patients with an infected diabetic foot ulcer presenting to 1 of 14 diabetic foot clinics in 10 European countries. RESULTS: Among these patients, 159 (28%) underwent an amputation. Independent risk factors for amputation were as follows: periwound edema, foul smell, (non)purulent exudate, deep ulcer, positive probe-to-bone test, pretibial edema, fever, and elevated C-reactive protein. Increasing IWGDF severity of infection also independently predicted amputation. We developed a risk score for any amputation and for amputations excluding the lesser toes (including the variables sex, pain on palpation, periwound edema, ulcer size, ulcer depth, and peripheral arterial disease) that predicted amputation better than the IWGDF system (area under the ROC curves 0.80, 0.78, and 0.67, respectively). CONCLUSIONS: For individuals with an infected diabetic foot ulcer, we identified independent predictors of amputation, validated the prognostic value of the IWGDF classification system, and developed a new risk score for amputation that can be readily used in daily clinical practice. Our risk score may have better prognostic accuracy than the IWGDF system, the only currently available system, but our findings need to be validated in other cohorts.

Exploring the concept of a team approach to wound care: Managing wounds as a team.

Background - The growing prevalence and incidence of nonhealing acute and chronic wounds is a worrying concern. A major challenge is the lack of united services aimed at addressing the complex needs of individuals with wounds. However, the WHO argues that interprofessional collaboration in education and practice is key to providing the best patient care, enhancing clinical and health-related outcomes and strengthening the health system. It is based on this background that the team approach to wound care project was conceptualised. The project was jointly initiated and realised by the Association for the Advancement of Wound Care (AAWC-USA), the Australian Wound Management Association (AWMA) and the European Wound Management Association (EWMA). Aim - The aim of this project was to develop a universal model for the adoption of a team approach to wound care. Objective The overarching objective of this project was to provide recommendations for implementing a team approach to wound care within all clinical settings and through this to develop a model for advocating the team approach toward decision makers in national government levels. Method An integrative literature review was conducted. Using this knowledge, the authors arrived at a consensus on the most appropriate model to adopt and realise a team approach to wound care. Results - Eighty four articles met the inclusion criteria. Following data extraction, it was evident that none of the articles provided a definition for the terms multidisciplinary, interdisciplinary or transdisciplinary in the context of wound care. Given this lack of clarity within the wound care literature, the authors have here developed a Universal Model for the Team Approach to Wound Care to fill this gap in our current understanding. Conclusion - We advocate that the patient should be at the heart of all decision-making, as working with the Universal Model for the Team Approach to Wound Care begins with the needs of the patient. To facilitate this, we suggest use of a wound navigator who acts as an advocate for the patient. Overall, we feel that the guidance provided within this document serves to illuminate the importance of a team approach to wound care, in addition to providing a clear model on how to achieve such an approach to care. We look forward to gathering evidence of the impact of this model of care on clinical and financial outcomes and will continue to share updates over time.

Burden of diabetic foot disorders, guidelines for management and disparities in implementation in Europe: a systematic literature review.

The study aimed to assess the economic and quality of life burden of diabetic foot disorders and to identify disparities in the recommendations from guidelines and the current clinical practice across the EU5 (Spain, Italy, France, UK and Germany) countries. Literature search of electronic databases (MEDLINE®, Embase® and Cochrane Database of Systematic Reviews) was undertaken. English language studies investigating economic and resource burden, quality of life and management of diabetic foot disease in the EU5 countries were included. Additionally, websites were screened for guidelines and current management practices in diabetic foot complication in EU5. Diabetic foot complications accounted for a total annual cost of €509m in the UK and €430 per diabetic patient in Germany, during 2001. The cost of diabetic foot complications increased with disease severity, with hospitalizations (41%) and amputation (9%) incurring 50% of the cost. Medical devices (orthopaedic shoes, shoe lifts and walking aids) were the most frequently utilized resources. Patients with diabetic foot complications experienced worsened quality of life, especially in those undergoing amputations and with non-healed ulcers or recurrent ulcers. Although guidelines advocate the use of multidisciplinary foot care teams, the utilization of multidisciplinary foot care teams was suboptimal. We conclude that diabetic foot disorders demonstrated substantial economic burden and have detrimental effect on quality of life, with more impairment in physical domain. Implementation of the guidelines and set-up of multidisciplinary clinics for holistic management of the diabetic foot disorders varies across Europe and remains suboptimal. Hence, guidelines need to be reinforced to prevent diabetic foot complications and to achieve limb salvage if complications are unpreventable.

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.

Health-related quality of life predicts major amputation and death, but not healing, in people with diabetes presenting with foot ulcers: the Eurodiale study.

OBJECTIVE: Low health-related quality of life (HRQoL) has been consistently reported to be associated with poor prognosis for a variety of health outcomes in various settings. We aimed to evaluate whether HRQoL in patients presenting with new diabetic foot ulcers (DFUs) has prognostic significance for ulcer healing, major amputation, and death. RESEARCH DESIGN AND METHODS: We followed 1,088 patients with new DFUs presenting for treatment at one of the 14 centers in 10 European countries participating in the Eurodiale (European Study Group on Diabetes and the Lower Extremity) study, prospectively until healing (76.9%), major amputation (4.6%), or death (6.4%) up to a maximum of 1 year. At baseline, patient and ulcer characteristics were recorded as well as EQ-5D, a standardized instrument consisting of five domains and a visual analog scale for use as a measure of HRQoL. The prognostic influence of the EQ-5D domains was evaluated in multivariable Cox regression analyses on the time-to-event data, adjusting for baseline clinical characteristics of the ulcer and comorbidities. RESULTS: While predictive effects of HRQoL, adjusted for possible confounders, were absent for healing, decreased HRQoL, especially in the physical domains, was statistically significant for major amputation (mobility, self-care, usual activities) and death (self-care, usual activities, pain/discomfort). CONCLUSIONS: Low HRQoL appears to be predictive for major amputation and death, but high HRQoL does not increase healing. Future studies into the influence of HRQoL on ulcer outcome are important in attempts to decrease treatment failure and mortality.

The effectiveness of text messages support for diabetes self-management: protocol of the TEXT4DSM study in the democratic Republic of Congo, Cambodia and the Philippines.

BACKGROUND: People with diabetes find it difficult to sustain adequate self-management behaviour. Self-Management Support strategies, including the use of mobile technology, have shown potential benefit. This study evaluates the effectiveness of a mobile phone support intervention on top of an existing strategy in three countries, DR Congo, Cambodia and the Philippines to improve health outcomes, access to care and enablement of people with diabetes, with 480 people with diabetes in each country who are randomised to either standard support or to the intervention. DESIGN/METHODS: The study consists of three sub-studies with a similar design in three countries to be independently implemented and analysed. The design is a two-arm Randomised Controlled Trial, in which a total of 480 adults with diabetes participating in an existing DSME programme will be randomly allocated to either usual care in the existing programme or to usual care plus a mobile phone self-management support intervention. Participants in both arms complete assessments at baseline, one year and two years after inclusion.Glycosylated haemoglobin blood pressure, height, weight, waist circumference will be measured. Individual interviews will be conducted to determine the patients' assessment of chronic illness care, degree of self-enablement, and access to care before implementation of the intervention, at intermediate moments and at the end of the study.Analyses of quantitative data including assessment of differences in changes in outcomes between the intervention and usual care group will be done. A probability of <0.05 is considered statistically significant. Outcome indicators will be plotted over time. All data are analysed for confounding and interaction in multivariate regression analyses taking potential clustering effects into account.Differences in outcome measures will be analysed per country and realistic evaluation to assess processes and context factors that influence implementation in order to understand why it works, for whom, under which circumstances. A costing study will be performed. DISCUSSION: The intervention addresses the problem that the greater part of diabetes management takes place without external support and that many challenges, unforeseen problems and questions occur at moments in between scheduled contacts with the support system, by exploiting communication technology. TRIAL REGISTRATION: ISRCTN86247213.