Metabolic predictors of pain, fatigue, depression and quality of life in people with long-term type 1 diabetes-the Dialong study.

AIM: To examine associations of metabolic parameters (mean 30 years' time-weighted HbA1c and low-density lipoprotein-cholesterol [LDL-c], current methionine sulfoxide [MetSO], advanced glycation end products [AGEs], inflammatory markers and hypoglycaemia) with pain, fatigue, depression and quality of life (QoL) in people with long-term type 1 diabetes. METHODS: A total of 104 persons with type 1 diabetes ≥45 years duration were included. Participants completed questionnaires measuring bodily pain (RAND-36 bodily pain domain with lower scores indicate higher levels of bodily pain), fatigue (Fatigue Questionnaire), depression (Patient Health Questionnaire), overall QoL (World Health Organization Quality of Life-BREF) and diabetes-related QoL (Audit of Diabetes-Dependent Quality of Life). In this observational study, mean time-weighted HbA1c and LDL-c were calculated based on longitudinal measures obtained from medical records of up to 34 years, while current HbA1c , LDL-c and inflammatory markers were analysed in blood samples and collagen MetSO and AGEs in skin biopsies. History of hypoglycaemia was self reported. Associations between metabolic parameters and questionnaire scores were analysed using linear regression analyses and are reported as standardized regression coefficients (beta). RESULTS: Of the metabolic variables, higher mean time-weighted HbA1c was associated with higher levels of bodily pain and total fatigue (beta [p-value]) -0.3 (<0.001) and 0.2 (0.001). CONCLUSIONS: Long-term chronic hyperglycaemia may have a negative influence on pain and fatigue in people with type 1 diabetes. These results may assist health care workers in emphasizing the importance of strict glycaemic control in people with diabetes and identifying and treating type 1 diabetes-related pain and fatigue.

The bidirectional longitudinal association between depressive symptoms and HbA1c : A systematic review and meta-analysis.

AIM: To investigate whether there is a bidirectional longitudinal association of depression with HbA1c . METHODS: We conducted a systematic literature search in PubMed, PsycINFO, CINAHL and EMBASE for observational, longitudinal studies published from January 2000 to September 2020, assessing the association between depression and HbA1c in adults. We assessed study quality with the Newcastle-Ottawa-Scale. Pooled effect estimates were reported as partial correlation coefficients (rp ) or odds ratios (OR). RESULTS: We retrieved 1642 studies; 26 studies were included in the systematic review and eleven in the meta-analysis. Most studies (16/26) focused on type 2 diabetes. Study quality was rated as good (n = 19), fair (n = 2) and poor (n = 5). Of the meta-analysed studies, six investigated the longitudinal association between self-reported depressive symptoms and HbA1c and five the reverse longitudinal association, with a combined sample size of n = 48,793 and a mean follow-up of 2 years. Higher levels of baseline depressive symptoms were associated with subsequent higher levels of HbA1c (partial r = 0.07; [95% CI 0.03, 0.12]; I2 38%). Higher baseline HbA1c values were also associated with 18% increased risk of (probable) depression (OR = 1.18; [95% CI 1.12,1.25]; I2 0.0%). CONCLUSIONS: Our findings support a bidirectional longitudinal association between depressive symptoms and HbA1c . However, the observed effect sizes were small and future research in large-scale longitudinal studies is needed to confirm this association. Future studies should investigate the role of type of diabetes and depression, diabetes distress and diabetes self-management behaviours. Our results may have clinical implications, as depressive symptoms and HbA1c levels could be targeted concurrently in the prevention and treatment of diabetes and depression. REGISTRATION: PROSPERO ID CRD42019147551.

Undiagnosed diabetes: Prevalence and cardiovascular risk profile in a population-based study of 52,856 individuals. The HUNT Study, Norway.

AIMS: We investigated the current extent of undiagnosed diabetes and prediabetes and their associated cardiovascular risk profile in a population-based study. METHODS: All residents aged ≥20 years in the Nord-Trøndelag region, Norway, were invited to the HUNT4 Survey in 2017-2019, and 54% attended. Diagnosed diabetes was self-reported, and in those reporting no diabetes HbA1c was used to classify undiagnosed diabetes (≥48 mmol/mol [6.5%]) and prediabetes (39-47 mmol/mol [5.7%-6.4%]). We estimated the age- and sex-standardized prevalence of these conditions and their age- and sex-adjusted associations with other cardiovascular risk factors. RESULTS: Among 52,856 participants, the prevalence of diabetes was 6.0% (95% CI 5.8, 6.2), of which 11.1% were previously undiagnosed (95% CI 10.1, 12.2). The prevalence of prediabetes was 6.4% (95% CI 6.2, 6.6). Among participants with undiagnosed diabetes, 58% had HbA1c of 48-53 mmol/mol (6.5%-7.0%), and only 14% (i.e., 0.1% of the total study population) had HbA1c >64 mmol/mol (8.0%). Compared with normoglycaemic participants, those with undiagnosed diabetes or prediabetes had higher body mass index, waist circumference, systolic blood pressure, triglycerides and C-reactive protein but lower low-density lipoprotein cholesterol (all p < 0.001). Participants with undiagnosed diabetes had less favourable values for every measured risk factor compared with those with diagnosed diabetes. CONCLUSIONS: The low prevalence of undiagnosed diabetes suggests that the current case-finding-based diagnostic practice is well-functioning. Few participants with undiagnosed diabetes had very high HbA1c levels indicating severe hyperglycaemia. Nonetheless, participants with undiagnosed diabetes had a poorer cardiovascular risk profile compared with participants with known or no diabetes.

Correlated physical and mental health composite scores for the RAND-36 and RAND-12 health surveys: can we keep them simple?

BACKGROUND: The RAND-36 and RAND-12 (equivalent to versions 1 of the SF-36 Health Survey and SF-12 Health Survey, respectively) are widely used measures of health-related quality of life. However, there are diverging views regarding how to create the physical health and mental health composite scores of these questionnaires. We present a simple approach using an unweighted linear combination of subscale scores for constructing composite scores for physical and mental health that assumes these scores should be free to correlate. The aim of this study was to investigate the criterion validity and convergent validity of these scores. METHODS: We investigated oblique and unweighted RAND-36/12 composite scores from a random sample of the general Norwegian population (N = 2107). Criterion validity was tested by examining the correlation between unweighted composite scores and weighted scores derived from oblique principal component analysis. Convergent validity was examined by analysing the associations between the different composite scores, age, gender, body mass index, physical activity, rheumatic disease, and depression. RESULTS: The correlations between the composite scores derived by the two methods were substantial (r = 0.97 to 0.99) for both the RAND-36 and RAND-12. The effect sizes of the associations between the oblique versus the unweighted composite scores and other variables had comparable magnitudes. CONCLUSION: The unweighted RAND-36 and RAND-12 composite scores demonstrated satisfactory criterion validity and convergent validity. This suggests that if the physical and mental composite scores are free to be correlated, the calculation of these composite scores can be kept simple.

The prevalence and incidence of pharmacologically treated diabetes among older people receiving home care services in Norway 2009-2014: a nationwide longitudinal study.

BACKGROUND: A substantial proportion of older people who receive home care services (HCS) has diabetes and requires diabetes specific monitoring, treatment and self-care assistance. However, the prevalence and incidence rates of diabetes among older people in HCS are poorly described. The aim of the study is to estimate prevalence, incidence and time trends of pharmacologically treated diabetes among older people receiving HCS in Norway 2009-2014. METHODS: This nationwide observational cohort study is based on data from two population registries. The study population consisted of persons registered in the Norwegian Information System for the Nursing and Care Sector aged ≥ 65 years receiving HCS during at least one of the years 2009-2014. The Norwegian Prescription Database was utilized to identify participants' prescriptions for glucose lowering drugs (GLD). The period prevalence was calculated each year as persons with one or more prescriptions of GLD in the current or previous year. Incident cases were defined as subjects receiving prescriptions of GLD for the first time in the given calendar year if there were no prescriptions of any GLD for that person during the previous two years. RESULTS: From 2009 to 2014, the number of older people receiving HCS increased from 112,487 to 125,593. The proportion of these who received GLD increased from 14.2% to 15.7% (p < 0.001) and was significantly higher among men than women. The annual incidence rate of diabetes among those receiving HCS showed a decreasing trend from 95.4 to 87.5 cases per 10,000 person-years from 2011 to 2014, but when stratifying on age group and gender, was significant only among the oldest women (age groups 85-89 years and 90 +). CONCLUSIONS: The increasing prevalence of older people with diabetes who receive HCS highlights the importance of attention to treatment and care related to diabetes in the HCS.

Gestational diabetes mellitus by maternal country of birth and length of residence in immigrant women in Norway.

AIMS: Immigrant women are at higher risk for gestational diabetes mellitus (GDM) than non-immigrant women. This study described the prevalence of GDM in immigrant women by maternal country of birth and examined the associations between immigrants' length of residence in Norway and GDM. METHODS: This Norwegian national population-based study included 192,892 pregnancies to immigrant and 1,116,954 pregnancies to non-immigrant women giving birth during the period 1990-2013. Associations were reported as odds ratios (ORs) with 95% confidence intervals (CIs) using logistic regression models, adjusted for year of delivery, maternal age, marital status, health region, parity, education and income. RESULTS: The prevalence and adjusted OR [CI] for GDM were substantially higher in immigrant women from Bangladesh (7.4%, OR 8.38 [5.41, 12.97]), Sri Lanka (6.3%, OR 7.60 [6.71, 8.60]), Pakistan (4.3%, OR 5.47 [4.90, 6.11]), India (4.4%, OR 5.18 [4.30, 6.24]) and Morocco (4.3%, OR 4.35 [3.63, 5.20]) compared to non-immigrants (prevalence 0.8%). Overall, GDM prevalence increased from 1.3% (OR 1.25 [1.14, 1.36]) to 3.3% (OR 2.55 [2.39, 2.71]) after 9 years of residence in immigrants compared to non-immigrant women. This association was particularly strong for women from South Asia. CONCLUSIONS: Gestational diabetes mellitus prevalence varied substantially between countries of maternal birth and was particularly high in immigrants from Asian countries. GDM appeared to increase with longer length of residence in certain immigrant groups.

The impact of the COVID-19 pandemic on people with diabetes and diabetes services: A pan-European survey of diabetes specialist nurses undertaken by the Foundation of European Nurses in Diabetes survey consortium.

AIM: To describe diabetes nurses' perspectives on the impact of the COVID-19 pandemic on people with diabetes and diabetes services across Europe. METHODS: An online survey developed using a rapid Delphi method. The survey was translated into 17 different languages and disseminated electronically in 27 countries via national diabetes nurse networks. RESULTS: Survey responses from 1829 diabetes nurses were included in the analysis. The responses indicated that 28% (n = 504) and 48% (n = 873) of diabetes nurses felt the COVID-19 pandemic had impacted 'a lot' on the physical and psychological risks of people with diabetes, respectively. The following clinical problems were identified as having increased 'a lot': anxiety 82% (n = 1486); diabetes distress 65% (n = 1189); depression 49% (n = 893); acute hyperglycaemia 39% (n = 710) and foot complications 18% (n = 323). Forty-seven percent (n = 771) of respondents identified that the level of care provided to people with diabetes had declined either extremely or quite severely. Self-management support, diabetes education and psychological support were rated by diabetes nurse respondents as having declined extremely or quite severely during the COVID-19 pandemic by 31% (n = 499), 63% (n = 1,027) and 34% (n = 551), respectively. CONCLUSION: The findings show that diabetes nurses across Europe have seen significant increases in both physical and psychological problems in their patient populations during COVID-19. The data also show that clinical diabetes services have been significantly disrupted. As the COVID-19 situation continues, we need to adapt care systems with some urgency to minimise the impact of the pandemic on the diabetes population.

Effect of a telemedicine intervention for diabetes-related foot ulcers on health, well-being and quality of life: secondary outcomes from a cluster randomized controlled trial (DiaFOTo).

BACKGROUND: Follow-up care provided via telemedicine (TM) is intended to be a more integrated care pathway to manage diabetes-related foot ulcers (DFU) than traditionally-delivered healthcare. However, knowledge of the effect of TM follow-up on PROMs including self-reported health, well-being and QOL in patients with DFUs is lacking and often neglected in RCT reports in general. Therefore, in this study of secondary outcomes from the DiaFOTo trial, the aim was to compare changes in self-reported health, well-being and QOL between patients with DFUs receiving telemedicine follow-up care in primary healthcare in collaboration with specialist healthcare, and patients receiving standard outpatient care. METHODS: The current study reports secondary endpoints from a cluster randomized controlled trial whose primary endpoint was ulcer healing time. The trial included 182 adults with diabetes-related foot ulcers (94/88 in the telemedicine/standard care groups) in 42 municipalities/districts, recruited from three clinical sites in Western Norway. Mean (SD) diabetes duration for the study population was 20.8 (15.0). The intervention group received care in the community in collaboration with specialist healthcare using an asynchronous telemedicine intervention. The intervention included an interactive web-based ulcer record and a mobile phone enabling counseling and communication between the community nurses and specialist healthcare; the control group received standard outpatient care. In total 156 participants (78/78) reported on secondary endpoints: self-reported health, well-being and quality of life evaluated by generic and disease-specific patient-reported outcome measures (e.g. Euro-QOL, the Hospital Anxiety and Depression Scale (HADS), Problem Areas in Diabetes (PAID), Neuropathy and Foot Ulcer-Specific Quality of Life Instrument (NeuroQOL)). Linear mixed-effects regression was used to investigate possible differences in changes in the scores between the intervention and control group at the end of follow-up. RESULTS: In intention to treat analyses, differences between treatment groups were small and non-significant for the health and well-being scale scores, as well as for diabetes-related distress and foot ulcer-specific quality of life. CONCLUSIONS: There were no significant differences in changes in scores for the patient reported outcomes between the intervention and control group, indicating that the intervention did not affect the participants' health, well-being and quality of life. TRIAL REGISTRATION: Clinicaltrials.gov , NCT01710774 . Registered October 19th, 2012.

Continuous glucose monitoring in adults with type 1 diabetes: A balance between benefits and barriers: A critical incident study.

AIMS AND OBJECTIVES: To describe positively and negatively perceived situations experienced by adults with type 1 diabetes using continuous glucose monitoring and the actions they take to deal with these situations. BACKGROUND: Real-time continuous glucose monitoring has been shown to improve glycaemic control and reduce hypoglycaemia. Although many patients with type 1 diabetes report great benefits when using continuous glucose monitoring, a substantial number discontinue using the device. Little is known about the different situations and experiences with the daily use of continuous glucose monitoring that contribute to such differences. DESIGN: A descriptive design based on the critical incident technique was used. The study complied with the Consolidated Criteria for Reporting Qualitative Research (COREQ) (see File S1). METHODS: Individual interviews were conducted with a purposive sample of 23 adults with type 1 diabetes, including current and former users of continuous glucose monitoring from four different outpatient clinics. RESULTS: The participants described that they felt that the use of continuous glucose monitoring was a balance between benefits and barriers, and how, through their actions, they tried to adapt their use of continuous glucose monitoring to fit their lifestyles. Various life events affected and altered the balance between benefits and barriers and thus affected their use of continuous glucose monitoring. CONCLUSIONS: Continuous glucose monitoring is perceived as an effective and important tool in the self-management of diabetes type 1. It enables a better everyday life and increased satisfaction with treatment. At the same time, the use of continuous glucose monitoring can be both demanding and challenging. RELEVANCE TO CLINICAL PRACTICE: Understanding the complex interplay between perceived benefits, treatment burden and adherence to continuous glucose monitoring use is important for nurses engaged in diabetes care. Education and support regarding the use of continuous glucose monitoring must be based on the understanding and perspectives of the patient to alleviate stress and barriers and enhance self-efficacy. As the use of continuous glucose monitoring can change over time, this must be a continuous process beyond initial training.

Telemedicine follow-up facilitates more comprehensive diabetes foot ulcer care: A qualitative study in home-based and specialist health care.

AIMS AND OBJECTIVES: To investigate the application of a telemedicine intervention in diabetes foot ulcer care, and its implications for the healthcare professionals in the clinical field. BACKGROUND: Contextual factors are found to be important when applying technology in health care and applying telemedicine in home-based care has been identified as particularly complex. DESIGN AND METHODS: We conducted field observations and individual interviews among healthcare professionals in home-based care and specialist health care in a diabetes foot care telemedicine RCT (Clin.Trial.gov: NCT01710774) during 2016. This study was guided by Interpretive Description, an inductive qualitative methodology. RESULTS: Overall, we identified unequal possibilities for applying telemedicine in diabetes foot ulcer care within the hospital and home care contexts. Different circumstances and possibilities in home-based care made the application of telemedicine as intended more difficult. The healthcare professionals in both care contexts perceived the application of telemedicine to facilitate a more comprehensive approach towards the patients, but with different possibilities to enact it. CONCLUSIONS: Application of telemedicine in home-based care was more challenging than in the outpatient clinic setting. Introducing more updated equipment and minor structural adjustments in consultation time and resources could make the use of telemedicine in home-based care more robust. RELEVANCE TO CLINICAL PRACTICE: Application of telemedicine in diabetes foot ulcer follow-up may enhance the nursing staff's ability to conduct comprehensive assessment and care of the foot ulcer as well as the patient's total situation. Access to adequate equipment and time, particularly in home-based care, is necessary to capitalise on this new technology.

Lasting impact of an implemented self-management programme for people with type 2 diabetes referred from primary care: a one-group, before-after design.

BACKGROUND: Research interventions in uniform clinical settings and in patients fulfilling well-defined inclusion criteria might show a more pronounced effect than implementing the same intervention in existing practice. Diabetes Self-Management Education (DSME) is complex, and should be assessed in existing practice as it is an intervention widely implemented. OBJECTIVES: To examine the impact of an established group-based DSME in unselected people with type 2 diabetes referred from primary care. METHOD: A one-group, before-after design was used for assessments before, immediately after, and 3 months after participation in a group-based DSME programme conducted at two Learning and Mastering Centres in Norway between November 2013 and June 2014. Participants completed a questionnaire before (n = 115), immediately after (n = 95) and 3 months after (n = 42) the DSME programme. Primary outcome measure was diabetes knowledge (Michigan Diabetes Knowledge Test). Also patient activation (Patient Activation Measure [PAM]) and self-efficacy (General Self-Efficacy scale [GSE]) were measured. Changes in outcome measures were analysed using paired t-tests for normally distributed data and Wilcoxon signed-rank test for skewed data. RESULTS: Mean knowledge improved significantly from baseline (p < 0.001). Changes persisted at the 3-month assessment. Mean PAM scores improved significantly from baseline (p < 0.001), and changes persisted for 3 months. Mean GSE scores improved from baseline (p = 0.022) and persisted for 3 months. However, when results were stratified for participants who responded at all three time points, GSE showed no change during the study period. CONCLUSION: The complexity self-management in the individual is challenging to reflect in DSME. This implemented DSME programme for people with type 2 diabetes improved levels of diabetes knowledge and patient activation, persisting for at least 3 months. Hence, the DSME programme appears to be robust beyond standardised research settings, in educating unselected diabetes patients referred from primary care.

Conditions for success in introducing telemedicine in diabetes foot care: a qualitative inquiry.

BACKGROUND: The uptake of various telehealth technologies to deliver health care services at a distance is expanding; however more knowledge is needed to help understand vital components for success in using telehealth in different work settings. This study was part of a larger trial designed to investigate the effect of an interactive telemedicine platform. The platform consisted of a web based ulcer record linked to a mobile phone to provide care for people with diabetic foot ulcers in outpatient clinics in specialist hospital care in collaboration with primary health care. The aim of this qualitative study was to identify perceptions of health care professionals in different working settings with respect to facilitators to engagement and participation in the application of telemedicine. METHODS: Ten focus groups were conducted with health care professionals and leaders in Western Norway between January 2014 and June 2015 using Interpretive Description, an applied qualitative research strategy. RESULTS: Four key conditions for success in using telemedicine as a new technology in diabetes foot care were identified: technology and training that were user-friendly; having a telemedicine champion in the work setting; the support of committed and responsible leaders; and effective communication channels at the organizational level. CONCLUSIONS: Successful larger scale implementation of telemedicine must involve consideration of complex contextual and organizational factors associated with different work settings. This form of new care technology in diabetes foot care often involves health care professionals working across different settings with different management systems and organizational cultures. Therefore, attention to the distinct needs of each staff group seems an essential condition for effective implementation.

Diabetic foot ulcer teams in Norwegian hospitals. / Diabetiske fotsårteam i norske sykehus.

BACKGROUND: The national clincial guidelines for diabetes recommend that diabetic foot ulcers be treated by interdisciplinary diabetic foot ulcer teams. This study aims to survey the extent of diabetic foot ulcer teams in the specialist health service in Norwegian hospitals and to describe their clinical composition, organisation and working routines. MATERIAL AND METHOD: The study is cross-sectional with the use of a questionnaire survey. The criteria for participating were somatic hospitals with 24-hour operations and a specialist function for patients with diabetes mellitus. A total of 41 hospitals participated of the 51 that fulfilled the criteria. RESULTS: Altogether 17 of 41 hospitals had diabetic foot ulcer teams. The teams had a broad clinical composition and followed national recommendations for surveying risk factors and treatment of diabetic foot ulcers. Nine foot ulcer teams had written routines for assessment, five used the Noklus diabetes patient records to document ulcer treatment, and ten had planned interdisciplinary meetings. Only one-quarter of the teams included both medical and surgical competence in the planned interdisciplinary collaboration. INTERPRETATION: The diabetic foot ulcer teams had broad clinical competence and followed national clinical guidelines. The teams had a short waiting time for the initial consultation, half had written guidelines, and 60 % had planned interdisciplinary meetings. Far fewer had included both medical and surgical competence in the planned interdisciplinary collaboration.

Telemedicine in diabetes foot care delivery: health care professionals' experience.

BACKGROUND: Introducing new technology in health care is inevitably a challenge. More knowledge is needed to better plan future telemedicine interventions. Our aim was therefore to explore health care professionals' experience in the initial phase of introducing telemedicine technology in caring for people with diabetic foot ulcers. METHODS: Our methodological strategy was Interpretive Description. Data were collected between 2014 and 2015 using focus groups (n = 10). Participants from home-based care, primary care and outpatient hospital clinics were recruited from the intervention arm of an ongoing cluster randomized controlled trial (RCT) (Clinicaltrials.gov: NCT01710774). Most were nurses (n = 29), but the sample also included one nurse assistant, podiatrists (n = 2) and physicians (n = 2). RESULTS: The participants reported experiencing meaningful changes to their practice arising from telemedicine, especially associated with increased wound assessment knowledge and skills and improved documentation quality. They also experienced more streamlined communication between primary health care and specialist health care. Despite obstacles associated with finding the documentation process time consuming, the participants' attitudes to telemedicine were overwhelmingly positive and their general enthusiasm for the innovation was high. CONCLUSIONS: Our findings indicate that using a telemedicine intervention enabled the participating health care professionals to approach their patients with diabetic foot ulcer with more knowledge, better wound assessment skills and heightened confidence. Furthermore, it streamlined the communication between health care levels and helped seeing the patients in a more holistic way.

Characteristics of nursing studies in diabetes research published over three decades in Sweden, Norway, Denmark and Iceland: a narrative review of the literature.

Similarities and differences across borders of Nordic countries constitute a suitable context for investigating and discussing factors related to the development of diabetes nursing research over the last three decades. The present study reviewed the entire body of contemporary diabetes nursing research literature originating in four Nordic countries: Norway, Sweden, Denmark and Iceland. Our aims were (i) to catalogue and characterise trends in research designs and research areas of these studies published over time and (ii) to describe how research involving nurses in Nordic countries has contributed to diabetes research overall. The larger goal of our analyses was to produce a comprehensive picture of this research in order to guide future studies in the field. We conducted a narrative literature review by systematically searching Medline, Medline in process, EMBASE, CINAHL, PsycINFO and Cochrane databases. These searches were limited to studies published between 1979 and 2009 that had an abstract available in English or a Nordic language. Two researchers independently selected studies for analysis, leading to the inclusion of 164 relevant publications for analysis. In summary, Nordic nurse researchers have contributed to the development of new knowledge in self-management of diabetes in childhood, adolescence and adulthood, and to some extent also in the treatment and care of diabetes foot ulcers. Future research may benefit from (i) larger nurse-led research programmes organised in networks in order to share knowledge and expertise across national groups and borders, (ii) more multidisciplinary collaborations in order to promote patient-centred care and (iii) further research directed towards improving the dissemination and implementation of research findings. Using complex intervention designs and a mix of research methods will enrich the research.

A pilot study testing the feasibility of skin temperature monitoring to reduce recurrent foot ulcers in patients with diabetes--a randomized controlled trial.

BACKGROUND: Although monitoring foot skin temperatures has been associated with diabetic foot ulcer recurrence, no studies have been carried out to test the feasibility among European Caucasians. Moreover, the educational and/or motivational models that promote cognitive or psychosocial processes in these studies are lacking. Thus, we conducted a pilot randomized controlled trial to test the feasibility of monitoring foot skin temperatures in combination with theory-based counselling to standard foot care to reduce diabetic foot ulcer recurrence. METHODS: In a single-blinded nurse-led 1-year controlled trial, conducted at a hospital setting in Norway, 41 patients with diabetic neuropathy and previous foot ulcer were randomized to the intervention (n = 21) or control groups (n = 20). All participants were instructed in foot care and recording observations daily. Additionally, the intervention group was taught how to monitor and record skin temperature at baseline, and received counselling every third month supporting them to use the new treatment. Subjects observing temperature differences > 2.0 °C between corresponding sites on the left and right foot on two consecutive days were asked to contact the study nurse and reduce physical activity. Fisher exact test was used to evaluate the effect of the intervention on the proportion of subjects with a foot ulcer. Kaplan-Meier survival analysis was performed to compare the two groups in regard to the time to development of a foot ulcer. RESULTS: In the intervention group, 67 % (n = 14/21) monitored and recorded skin temperatures ≥ 80 % of the time while 70 % (n = 14/20) of the controls recorded foot inspections. Foot ulcer incidence was 39 % (7/21) vs. 50 % (10/20) in the intervention and control groups, respectively (ns). CONCLUSIONS: This feasibility study showed that the addition of counselling to promote self-monitoring of skin temperature to standard care to prevent recurrence of foot ulcer is feasible in patients with diabetes in Norway. Home skin temperature monitoring was performed as frequently by the intervention group as usual foot observations in the controls despite the extra effort required. We did not detect a difference in foot ulcer recurrence between groups, but our study may inform future full scale studies. TRIAL REGISTRATION: Clinicaltrials.gov NCT01269502.

Effect of telemedicine follow-up care of leg and foot ulcers: a systematic review.

BACKGROUND: Leg ulcers and diabetes-related foot ulcers are frequent and costly complications of their underlying diseases and thus represent a critical issue for public health. Since the population is aging, the prevalence of these conditions will probably increase considerably and require more resources. Treatment of leg and foot ulcers often demands frequent contact with the health care system, may pose great burden on the patient, and involves follow-up in both primary and specialist care. Telemedicine provides potential for more effective care management of leg and foot ulcers. The objective of this systematic review of the literature was to assess the effect of telemedicine follow-up care on clinical, behavioral or organizational outcomes among patients with leg and foot ulcers. METHODS: We searched Ovid MEDLINE (1980-), Ovid EMBASE (1980-), Clinical Trials in the Cochrane Library (via Wiley), Ebsco CINAHL with Fulltext (1981-) and SveMed + (1977-) up to May 2014 for relevant articles. We considered randomized controlled trials, non-randomized trials, controlled before-after studies and prospective cohort studies for inclusion and selected studies according to predefined criteria. Three reviewers independently assessed the included studies using the Cochrane Collaboration risk-of-bias tool. We performed a narrative synthesis of results and assessed the strength of evidence for each outcome using GRADE (grading of recommendations, assessment, development and evaluation). RESULTS: Only one non-randomized study was included. The study (n = 140) measured the effect of real-time interactive video consultation compared with face-to-face follow-up on healing time, adjusted healing ratio and the number of ulcers at 12 weeks among patients with neuropathic forefoot ulcerations. There were no statistically significant differences in results of the different outcomes between patients receiving telemedicine and traditional follow-up. We assessed the study to have a high risk of bias. CONCLUSIONS: There is insufficient evidence available to unambiguously determine whether telemedicine consultation of leg and foot ulcers is as effective as traditional follow-up.

Associations between HbA1c Reduction and Change in Depressive Symptoms following Glucose-lowering Treatment in Adults: A Systematic Review of Intervention Studies.

INTRODUCTION: Hyperglycemia constitutes a likely pathway linking diabetes and depressive symptoms; lowering glycemic levels may help reduce diabetes-comorbid depressive symptoms. Since randomized controlled trials can help understand temporal associations, we systematically reviewed the evidence regarding the potential association of hemoglobin HbA1c lowering interventions with depressive symptoms. METHODS: PubMed, PsycINFO, CINAHL, and EMBASE databases were searched for randomized controlled trials evaluating HbA1c-lowering interventions and including assessment of depressive symptoms published between 01/2000-09/2020. Study quality was evaluated using the Cochrane Risk of Bias tool. PROSPERO registration: CRD42020215541. RESULTS: We retrieved 1,642 studies of which twelve met our inclusion criteria. Nine studies had high and three unclear risks of bias. Baseline depressive symptom scores suggest elevated depressive symptoms in five studies. Baseline HbA1c was <8.0% (<64 mmol/mol) in two, 8.0-9.0% (64-75 mmol/mol) in eight, and ≥10.0% (≥86 mmol/mol) in two studies. Five studies found greater HbA1c reduction in the treatment group; three of these found greater depressive symptom reduction in the treatment group. Of four studies analyzing whether the change in HbA1c was associated with the change in depressive symptoms, none found a significant association. The main limitation of these studies was relatively low levels of depressive symptoms at baseline, limiting the ability to show a lowering in depressive symptoms after HbA1c reduction. CONCLUSIONS: We found insufficient available data to estimate the association between HbA1c reduction and depressive symptom change following glucose-lowering treatment. Our findings point to an important gap in the diabetes treatment literature. Future clinical trials testing interventions to improve glycemic outcomes might consider measuring depressive symptoms as an outcome to enable analyses of this association.

Decreasing lifetime prevalence of diabetes-related foot ulcers in Norway: repeated cross-sectional population-based surveys from the HUNT study (1995-2019).

Background and aims: Diabetes-related foot ulcers (DFU) are a persistent healthcare challenge, impacting both patients and healthcare systems, with adverse effects on quality of life and productivity. Our primary aim was to examine the trends in lifetime prevalence of DFU, as well as other micro- and macrovascular complications in the Trøndelag Health Study (HUNT) in Norway. Methods: This study consists of individuals ≥20 years with diabetes participating in the population-based cross-sectional HUNT surveys (1995-2019). Prevalence ratios, comparing the lifetime prevalence of DFU and other relevant micro- and macrovascular complications between the HUNT surveys, were calculated using Poisson regression. Results: The lifetime prevalence (95% confidence interval (CI)) of a DFU requiring three or more weeks to heal was 11.0% (9.5-12.7) in HUNT2, 7.5% (6.3-8.8) in HUNT3 and 5.3% (4.4-6.3) in HUNT4. The decrease in DFU prevalence from 1995 to 2019 was observed in both men and women, for all age groups, and for both type 1 and type 2 diabetes. The highest lifetime prevalence of DFU was found among those with type 1 diabetes. The decrease in HbA1c from HUNT2 to HUNT4 did not differ between those with and without a DFU. The prevalence of chronic kidney disease (eGFR <60 mL/min/1.73 m2 (eGFR categories G3-G5)) increased in both individuals with and without a DFU. Conclusion: Results from the HUNT surveys show a substantial decline in the lifetime prevalence of DFU from 1995 to 2019.