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.

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.

Diabetes Distress and Associations With Demographic and Clinical Variables: A Nationwide Population-Based Registry Study of 10,186 Adults With Type 1 Diabetes in Norway.

OBJECTIVE: To estimate diabetes distress prevalence and associations with demographic and clinical variables among adults with type 1 diabetes in Norway. RESEARCH DESIGN AND METHODS: In this nationwide population-based registry study, the 20-item Problem Areas in Diabetes (PAID-20) questionnaire was sent to 16,255 adults with type 1 diabetes. Linear regression models examined associations of demographic and clinical variables with distress. RESULTS: In total, 10,186 individuals (62.7%) completed the PAID-20, with a mean score of 25.4 (SD 18.4) and 21.7% reporting high distress. Respondents endorsed worrying about the future and complications as the most problematic item (23.0%). Female sex, younger age, non-European origin, primary education only, unemployment, smoking, continuous glucose monitoring use, more symptomatic hypoglycemia, reduced foot sensitivity, treated retinopathy, and higher HbA1c were associated with higher distress. CONCLUSIONS: Diabetes distress is common among adults with type 1 diabetes and associated with clinically relevant factors, underlining that regular care should include efforts to identify and address distress.

Assessing the content validity of the Manchester-Oxford Foot Questionnaire in surgically treated ankle fracture patients: a qualitative study.

BACKGROUND: Roughly 10% of fractures in adults are ankle fractures. These injuries are found in both sexes and present with different fracture characteristics. The treatment varies with the patients' biology and fracture type, and the goals are to restore stability, prevent pain and maintain ankle function. Clinicians generally use outcomes like assessment of radiography, pain level, or function. The use of patient-reported outcome measures is increasing, and the Manchester-Oxford Foot Questionnaire (MOXFQ) has been shown to have good measurement properties when validated in patients with foot and ankle disorders. However, the instrument has not been validated for ankle fracture patients. This study aims to assess the content validity of the items in MOXFQ in surgically treated ankle fracture patients. METHODS: A qualitative deductive design was used to investigate patients' response process of the MOXFQ. Individual interviews were conducted using cognitive interviewing based on the theoretical framework of the 4-step model by Tourangeau. Adult patients that were surgically treated for an ankle fracture between four weeks and 18 months were purposively sampled, and interviews followed a semi-structured interview guide. The predetermined categories were comprehension, retrieval, judgement, and response. RESULTS: Seventeen respondents (65% females) were interviewed. Respondents' age ranged from 27 to 76 years. Some of the respondents in the early recovery phase were limited by post-operative restrictions and did not find the items in the walking/standing domain relevant. Respondents that were allowed weight-bearing as tolerated (WBAT) were able to recall relevant information for most items. Respondents with time since surgery more than 12 months had less pain and remembered fewer relevant episodes in the recall period. Items in the social interaction domain contained ambiguous questions and were generally considered less important by respondents. The summary index score lacked important concepts in measuring overall quality of life. CONCLUSIONS: Pain was a central concept in the post-operative recovery of ankle fracture patients. The MOXFQ-subscales for pain and walking/standing had acceptable content validity in patients that were allowed WBAT. The social interaction-subscale and the summary index score had insufficient content validity for this patient population.

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.

Lower education and immigrant background are associated with lower participation in a diabetes education program - Insights from adult patients in the Outcomes & Multi-morbidity In Type 2 diabetes cohort (OMIT).

OBJECTIVES: Diabetes educational programmes should be offered to patients with type 2 diabetes mellitus (T2DM). We assessed the proportion of diabetes educational program participation among adults with T2DM, and its associations with place of residence in Norway, education, and immigrant background. METHODS: We identified 28,128 diagnosed with T2DM (2008-2019) in the Outcomes & Multi-morbidity In Type 2 diabetes cohort. To examine associations between sociodemographic factors and participation in diabetes start courses (yes/no), we computed adjusted risk ratios (95% CI) using log-binomial regression. RESULTS: Overall, 18% participated on the diabetes start course, but partaking differed by Norwegian counties (range:12-34%). Individuals with an immigrant background were 29% less likely to participate (RR 0.71, CI 0.65-0.79). Similarly, those with a lower educational level were 23% less likely to participate (RR 0.77, CI 0.72-0.83) than those with the highest education. The association between education and start course participation was not significant in the subgroup of immigrant individuals (RR 0.88 CI 0.70-1.12). CONCLUSIONS: We found that diabetes start course participation was overall low, especially in individuals with low education and immigrant background. PRACTICE IMPLICATIONS: More efforts are needed to promote diabetes start courses in patients with T2DM.

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.

A Network Analysis of the Fear of COVID-19 Scale (FCV-19S): A Large-Scale Cross-Cultural Study in Iran, Bangladesh, and Norway.

The rapid spread of the coronavirus disease 2019 (COVID-19) has led to high levels of fear worldwide. Given that fear is an important factor in causing psychological distress and facilitating preventive behaviors, assessing the fear of COVID-19 is important. The seven-item Fear of COVID-19 Scale (FCV-19S) is a widely used psychometric instrument to assess this fear. However, the factor structure of the FCV-19S remains unclear according to the current evidence. Therefore, the present study used a network analysis to provide further empirical evidence for the factor structure of FCV-19S. A total of 24,429 participants from Iran (n = 10,843), Bangladesh (n = 9906), and Norway (n = 3680) completed the FCV-19S in their local language. A network analysis (via regularized partial correlation networks) was applied to investigate the seven FCV-19S items. Moreover, relationships between the FCV-19S items were compared across gender (males vs. females), age groups (18−30 years, 31−50 years, and >50 years), and countries (Iran, Bangladesh, and Norway). A two-factor structure pattern was observed (three items concerning physical factors, including clammy hands, insomnia, and heart palpitations; four items concerning psychosocial factors, including being afraid, uncomfortable, afraid of dying, and anxious about COVID-19 news). Moreover, this pattern was found to be the same among men and women, across age groups and countries. The network analysis used in the present study verified the two-factor structure for the FCV-19S. Future studies may consider using the two-factor structure of FCV-19S to assess the fear of COVID-19 during the COVID-19 era.

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.

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.

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.

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.

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.

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.

Preconception Folic Acid Supplement Use in Immigrant Women (1999-2016).

This study examines how preconception folic acid supplement use varied in immigrant women compared with non-immigrant women. We analyzed national population-based data from Norway from 1999-2016, including 1,055,886 pregnancies, of which 202,234 and 7,965 were to 1st and 2nd generation immigrant women, respectively. Folic acid supplement use was examined in relation to generational immigrant category, maternal country of birth, and length of residence. Folic acid supplement use was lower overall in 1st and 2nd generation immigrant women (21% and 26%, respectively) compared with Norwegian-born women (29%). The lowest use among 1st generation immigrant women was seen in those from Eritrea, Ethiopia, Morocco, and Somalia (around 10%). The highest use was seen in immigrant women from the United States, the Netherlands, Denmark, and Iceland (>30%). Folic acid supplement use increased with increasing length of residence in immigrant women from most countries, but the overall prevalence was lower compared with Norwegian-born women even after 20 years of residence (adjusted odds ratio: 0.63; 95% confidence interval: 0.60-0.67). This study suggests that immigrant women from a number of countries are less likely to use preconception folic acid supplements than non-immigrant women, even many years after settlement.

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.

Psychometric properties of the Norwegian version of the short form of The Problem Areas in Diabetes scale (PAID-5): a validation study.

OBJECTIVES: To assess the psychometric properties of the short form of The Problem Areas in Diabetes scale (PAID-5) in Norwegian adult patients with type 1 or type 2 diabetes. DESIGN: Cross-sectional survey design. METHODS: Participants (n=143) were included from three Western-Norway endocrinology outpatient clinics. Demographic and clinical data were collected in addition to questionnaires concerning diabetes-related distress, fear of hypoglycaemia, symptoms of depression, emotional well-being and perception of general health. Psychometric evaluation of the PAID-5 included confirming its postulated one-factor structure using confirmatory factor analysis (CFA) and assessing convergent validity, discriminant validity, internal consistency and test-retest reliability. The retest questionnaire was sent out 35±15 days after the initial assessment to those who agreed (n=117). RESULTS: The CFA for the PAID-5 scale showed excellent one-factor structure, and there was high internal consistency (α=0.89) and good test-retest reliability (Intraclass Correlation Coefficient, ICC=0.81). The PAID-5 correlated positively with fear of hypoglycaemia (r=0.598) and depression (r=0.380) and negatively with emotional well-being (r=-0.363) and perception of general health (r=-0.420), thus satisfying convergent validity. Patients who had experienced episodes of serious hypoglycaemia in the past 6 months had a significantly higher PAID-5 mean score (7.5, SD=4.95) than those who had not had these episodes (5.0, SD=4.2 (p=0.043)). CONCLUSION: The Norwegian PAID-5 was shown to be a reliable and valid short questionnaire for assessing diabetes-related distress among people with type 1 or type 2 diabetes. However, its ability to discriminate between groups needs to be tested further in larger samples. The PAID-5 scale can be a particularly valuable screening instrument in outpatient clinics, as its brevity makes it easy to use as a tool in patient-provider encounters. This short questionnaire is useful in the national diabetes registry or population cohort studies as it enables increased knowledge regarding the prevalence of diabetes-related distress.

The Effect of Telemedicine Follow-up Care on Diabetes-Related Foot Ulcers: A Cluster-Randomized Controlled Noninferiority Trial.

OBJECTIVE: To evaluate whether telemedicine (TM) follow-up of patients with diabetes-related foot ulcers (DFUs) in primary health care in collaboration with specialist health care was noninferior to standard outpatient care (SOC) for ulcer healing time. Further, we sought to evaluate whether the proportion of amputations, deaths, number of consultations per month, and patient satisfaction differed between the two groups. RESEARCH DESIGN AND METHODS: Patients with DFUs were recruited from three clinical sites in western Norway (2012-2016). The cluster-randomized controlled noninferiority trial included 182 adults (94/88 in the TM/SOC groups) in 42 municipalities/districts. The intervention group received TM follow-up care in the community; the control group received SOC. The primary end point was healing time. Secondary end points were amputation, death, number of consultations per month, and patient satisfaction. RESULTS: Using mixed-effects regression analysis, we found that TM was noninferior to SOC regarding healing time (mean difference -0.43 months, 95% CI -1.50, 0.65). When competing risk from death and amputation were taken into account, there was no significant difference in healing time between the groups (subhazard ratio 1.16, 95% CI 0.85, 1.59). The TM group had a significantly lower proportion of amputations (mean difference -8.3%, 95% CI -16.3%, -0.5%), and there were no significant differences in the proportion of deaths, number of consultations, or patient satisfaction between groups, although the direction of the effect estimates for these clinical outcomes favored the TM group. CONCLUSIONS: The results suggest that use of TM technology can be a relevant alternative and supplement to usual care, at least for patients with more superficial ulcers.

A longitudinal study on patients with diabetes and symptoms of gastroparesis - associations with impaired quality of life and increased depressive and anxiety symptoms.

AIMS: To examine patient reported outcomes (PRO) in patients previously assessed for diabetic gastroparesis, and to investigate how symptoms of gastroparesis evolve over time. In addition, to further evaluate outcomes in those with versus without diabetic gastroparesis at baseline. METHODS: Thirty-four patients with diabetes and gastrointestinal (GI) symptoms, diagnosed with or without diabetic gastroparesis in 2011-2013, were included in this follow-up study. PRO were measured with the Patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM), 36-Item Short Form Survey (SF-36), Patient assessment of upper gastrointestinal disorders-quality of life (PAGI-QOL) and Hospital Anxiety and Depression Scale (HADS). Demographic factors and clinical variables were also recorded. RESULTS: Participants diagnosed with gastroparesis had improved glycemic control (p=0.04) and less GI symptoms (p=0.001), after a follow-up time of 3.2years (mean). Both groups reported severely impaired quality of life (QoL). In total 47% reported symptoms of anxiety, 38% symptoms of depression (scores≥8). GI symptom severity or other PRO could not differentiate between the two groups. CONCLUSIONS: Patients diagnosed with diabetic gastroparesis, as well as those with gastroparesis symptoms - but normal gastric emptying, suffer from severely impaired QoL and a high burden of anxiety and depressive symptoms.