Prostate Biopsies Can Be Omitted in Most Patients with a Positive Stockholm3 Test and Negative Prostate Magnetic Resonance Imaging.

BACKGROUND: Magnetic resonance imaging (MRI) combined with the Stockholm3 test can be used to inform biopsy decision-making in patients with a suspicion of prostate cancer. OBJECTIVE: To determine the consequence of omitting biopsies in men with a positive Stockholm3 test and a negative MRI. DESIGN, SETTING, AND PARTICIPANTS: In a real-life setting, 438 men with a positive Stockholm3 test and a negative MRI underwent systematic biopsies from 2017 to 2020. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The Stockholm3 test result is a percentage risk score with or without a prostate volume cutoff. The main outcomes were the number of clinically significant (Gleason grade group [GG] ≥2) and nonsignificant (GG 1) prostate cancers. RESULTS AND LIMITATIONS: Median prostate-specific antigen was 4.5 ng/ml (interquartile range 2.8-6.4 ng/ml) and the median age was 69 yr. Systematic biopsies detected grade group (GG) ≥2 disease in 48 men (11%, 95% confidence interval [CI] 8.4-14.2%) and GG 1 disease in 94 men (21.5%, 95% CI 17.9-25.6%). Of 256 patients without a volume cutoff in the test report, GG ≥2 was detected in 37 men (14.5%, 95% CI 10.7-19.3%). Omitting biopsies in patients with a volume cutoff would miss 11 GG ≥2 cases (6%, 95% CI 3.4-10.5%), reduce the number of GG 1 cases detected by 37 (39.4%, 95% CI 30.1-49.5%), and avoid a total of 182 biopsies (41.6%, 95% CI 37.0-46.2%). Limitations include the lack of follow-up data. CONCLUSIONS: Systematic biopsies can be omitted in patients with a positive Stockholm3 test and a negative MRI when there is a volume cutoff in the test report. With no volume cutoff, biopsies can be considered with shared decision-making. PATIENT SUMMARY: When investigated on suspicion of prostate cancer with a positive Stockholm3 test and a negative MRI (magnetic resonance imaging), prostate biopsies are only necessary for a subgroup of patients. This can spare some men from undergoing biopsies and reduce the detection of clinically insignificant cancers.

Re-admission and quality of life among patients with chronic obstructive pulmonary disease after telemedicine video nursing consultation - a randomized study.

Background: Our previous study showed a reduced cumulative length of re-admission stays due to chronic obstructive pulmonary disease (COPD) exacerbations during one year after telemedicine video consultation (TVC). The current study evaluated the effects of TVC on the length of re-admission stays within 12 months follow up post-TVC compared to phone call follow up or COPD usual care in a randomized study. Our secondary aim was to assess the impact of TVC on the frequency of re-admissions within 12 months of follow up. Patient satisfaction, hospital anxiety and depression scale (HADS) and COPD assessment test (CAT) scores were also evaluated. Methods: The study was a prospective randomized study of COPD patients who after hospital discharge for acute COPD exacerbations, were randomized to monitoring by TVC at home compared to phone call follow up for two weeks by a specialist nurse at the hospital or usual COPD care. Prospectively, we compared the cumulative durations and frequencies of hospital re-admissions due to COPD exacerbations within 12 months follow up after TVC, phone call follow up or usual COPD care. Results: Among 173 COPD patients followed for 12 months, 99 were re-admitted. The median cumulative length of readmission stays per patient within 12 months post-TVC did not differ from those followed by phone calls or with usual COPD care. The number of patients re-admitted and the number of re-admissions due to COPD exacerbations were also equal in the three groups. Patient satisfaction was high among those followed by TVC and phone calls, and the HADS and CAT scores favorably declined from baseline to post-intervention in patients followed by TVC and phone calls. Conclusions: The study could not demonstrate a beneficial effect of TVC on the cumulative length of re-admission stays or on the number of re-admissions within 12 months following an acute COPD hospital stay, as compared to those followed by phone calls or with usual COPD care. Patient satisfaction was high among those followed by TVC and phone calls, and the declines in HADS and CAT scores seem to be consequences of increased empowerment and competence for good self-care in COPD patients, remaining through the one-year observation period.

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.

Effects of replacing PSA with Stockholm3 for diagnosis of clinically significant prostate cancer in a healthcare system - the Stavanger experience.

OBJECTIVE: To describe early experience of replacing PSA with Stockholm3 for detection of prostate cancer in primary care. DESIGN AND METHODS: Longitudinal observations, comparing outcome measures before and after the implementation of Stockholm3. SETTING: Stavanger region in Norway with about 370,000 inhabitants, 304 general practitioners (GPs) in 97 primary care clinics, and one hospital. INTERVENTION: GPs were instructed to use Stockholm3 instead of PSA as standard procedure for diagnosis of prostate cancer. MAIN OUTCOME MEASURES: Proportion of GP clinics that had ordered a Stockholm3 test. Number of men referred to needle biopsy. Distribution of clinically significant prostate cancer (csPC) (Gleason Score ≥7) and clinically non-significant prostate cancer (cnsPC) (Gleason Score 6), in needle biopsies. Estimation of direct healthcare costs. RESULTS: Stockholm3 was rapidly implemented as 91% (88/97) of the clinics started to use the test within 14 weeks. After including 4784 tested men, the percentage who would have been referred for prostate needle biopsy was 29.0% (1387/4784) if based on PSA level ≥3ng/ml, and 20.8% (995/4784) if based on Stockholm3 Risk Score (p < 0.000001). The proportion of positive biopsies with csPC increased from 42% (98/233) before to 65% (185/285) after the implementation. Correspondingly, the proportion of cnsPC decreased from 58% (135/233) before to 35% (100/285) after the implementation (p < 0.0017). Direct healthcare costs were estimated to be reduced by 23-28% per tested man. CONCLUSION: Replacing PSA with Stockholm3 for early detection of prostate cancer in primary care is feasible. Implementation of Stockholm3 resulted in reduced number of referrals for needle-biopsy and a higher proportion of clinically significant prostate cancer findings in performed biopsies. Direct healthcare costs decreased. KEY POINTS A change from PSA to Stockholm3 for the diagnosis of prostate cancer in primary care in the Stavanger region in Norway is described and assessed. •Implementation of a new blood-based test for prostate cancer detection in primary care was feasible. A majority of GP clinics started to use the test within three months. •Implementation of the Stockholm3 test was followed by: -a 28% reduction in number of men referred for urological prostate cancer work-up -an increase in the proportion of clinically significant cancer in performed prostate biopsies from 42 to 65% -an estimated reduction in direct health care costs between 23 and 28%.

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.

Type 2 diabetes in general practice in Norway 2005-2014: moderate improvements in risk factor control but still major gaps in complication screening.

OBJECTIVE: To assess the status of type 2 diabetes care in general practice and changes in the quality of care between 2005 and 2014, and to identify areas of diabetes care requiring improvement. RESEARCH DESIGN AND METHODS: Two cross-sectional surveys were performed that included patients with type 2 diabetes in selected areas (n=9464 in 2014, n=5463 in 2005). Quality of care was assessed based on key recommendations in national guidelines. Differences in clinical performance between 2005 and 2014 were assessed in regression models adjusting for age, sex, counties and clustering within general practices. RESULTS: Treatment targets were achieved in a higher proportion of patients in 2014 compared with 2005: hemoglobin A1c ≤7.0% (≤53 mmol/mol) in 62.8% vs 54.3%, blood pressure ≤135/80 mm Hg in 44.9% vs 36.6%, and total cholesterol ≤4.5 mmol/L in 49.9% vs 33.5% (all adjusted P≤0.001). Regarding screening procedures for microvascular complications, fewer patients had recorded an eye examination (61.0% vs 71.5%, adjusted P<0.001), whereas more patients underwent monofilament test (25.9% vs 18.7%, adjusted P<0.001). Testing for albuminuria remained low (30.3%) in 2014. A still high percentage were current smokers (22.7%). CONCLUSIONS: We found moderate improvements in risk factor control for patients with type 2 diabetes in general practice during the last decade, which are similar to improvements reported in other countries. We report major gaps in the performance of recommended screening procedures to detect microvascular complications. The proportion of daily smokers remains high. We suggest incentives to promote further improvements in diabetes care in Norway.

Shared Electronic Health Record Systems: Key Legal and Security Challenges.

Use of shared electronic health records opens a whole range of new possibilities for flexible and fruitful cooperation among health personnel in different health institutions, to the benefit of the patients. There are, however, unsolved legal and security challenges. The overall aim of this article is to highlight legal and security challenges that should be considered before using shared electronic cooperation platforms and health record systems to avoid legal and security "surprises" subsequent to the implementation. Practical lessons learned from the use of a web-based ulcer record system involving patients, community nurses, GPs, and hospital nurses and doctors in specialist health care are used to illustrate challenges we faced. Discussion of possible legal and security challenges is critical for successful implementation of shared electronic collaboration systems. Key challenges include (1) allocation of responsibility, (2) documentation routines, (3) and integrated or federated access control. We discuss and suggest how challenges of legal and security aspects can be handled. This discussion may be useful for both current and future users, as well as policy makers.

Severity and duration of diabetic foot ulcer (DFU) before seeking care as predictors of healing time: A retrospective cohort study.

OBJECTIVES: To investigate whether A) duration of ulcer before start of treatment in specialist health care, and B) severity of ulcer according to University of Texas classification system (UT) at start of treatment (baseline), are independent predictors of healing time. METHODS: This retrospective cohort study, based on electronic medical record data, included 105 patients from two outpatient clinics in Western Norway with a new diabetic foot ulcer during 2009-2011. The associations of duration of ulcer and ulcer severity with healing time were assessed using cumulative incidence curves and subdistribution hazard ratio estimated using competing risk regression with adjustment for potential confounders. RESULTS: Of the 105 participants, 45.7% achieved ulcer healing, 36.2% underwent amputations, 9.5% died before ulcer healing and 8.5% were lost to follow-up. Patients who were referred to specialist health care by a general practitioner ≥ 52 days after ulcer onset had a 58% (SHR 0.42, CI 0.18-0.98) decreased healing rate compared to patients who were referred earlier, in the adjusted model. High severity (grade 2/3, stage C/D) according to the UT classification system was associated with a decreased healing rate compared to low severity (grade1, stage A/B or grade 2, stage A) with SHR (95% CI) equal to 0.14 (0.05-0.43) after adjustment for referral time and other potential confounders. CONCLUSION: Early detection and referral by both the patient and general practitioner are crucial for optimal foot ulcer healing. Ulcer grade and severity are also important predictors for healing time, and early screening to assess the severity and initiation of prompt treatment is important.

An integrated wound-care pathway, supported by telemedicine, and competent wound management-Essential in follow-up care of adults with diabetic foot ulcers.

INTRODUCTION: Diabetic foot ulcers are a feared complication of diabetes. Care delivered via telemedicine is suggested to be a more integrated care pathway to manage diabetic foot ulcers than traditionally delivered healthcare. Our aim was to explore patients' experiences with telemedicine follow-up care as compared to traditional care. METHODS: Interpretive description was used as an analysis strategy. Data were collected using individual semi-structured interviews in the context of a larger ongoing clustered randomized controlled trial. Twenty-four patients (13 in the intervention group; 11 in the control group), aged 38-88 years were purposively recruited from the RCT in order to obtain a diverse sample in terms of group composition (intervention vs. control), age, gender, marital status, setting, and comorbidities present. The control group received traditional care. RESULTS: Three themes emerged from the interpretive analysis: competence of healthcare professionals, continuity of care, and easy access. This was independed of types of follow-up that had limited impact on the patients' follow-up experiences. Competence of healthcare professionals and continuity of care were crucial, because they can either enhance or jeopardize wound care. If these two latter factors were absent, patients would lose confidence in the wound care process. If this happened, patients pointed out that the expert knowledge of a specialist clinic was essential to receive good care. When telemedicine functioned optimally, telemedicine was an advantage in the treatment, because the images quickly captured changes in the wound healing that immediately could be corrected. Easy access is important for patients, but the importance of accessibility appears to be primary when the other two factors were present. CONCLUSION: The best wound care pathway for patients with diabetes foot ulcers is depended on a combination of competence and professional skills in wound management, and continuity of care. If telemedicine is functioning as intended, it can be an important additional tool.

Telemedicine Versus Standard Follow-Up Care for Diabetes-Related Foot Ulcers: Protocol for a Cluster Randomized Controlled Noninferiority Trial (DiaFOTo).

BACKGROUND: This paper presents the protocol for an ongoing study to evaluate a telemedicine follow-up intervention for patients with diabetes-related foot ulcers. Diabetes-related foot ulcers represent challenges for patients and the health services. The large increase in the prevalence of diabetes, combined with the aging population, means that the absolute number of patients with diabetes-related foot ulcers is likely to continue to increase. Health care services therefore need to provide close clinical follow-up care for people with diabetes both in primary and specialist care. Information and communication technologies may enable more integrated treatment and care pathways across organizational boundaries. However, we lack knowledge about the effect of telemedicine follow-up and how such services can be optimally organized. OBJECTIVE: To present the design and methods of a study evaluating a telemedicine follow-up intervention for patients with diabetes-related foot ulcers. METHODS: The study is designed as a cluster randomized controlled trial (noninferiority trial) involving municipalities or municipality districts (clusters) belonging to one clinical site in Western Norway. The study includes patients with type 1 and type 2 diabetes presenting with a new foot ulcer at the initial visit to the clinic. Patients in the intervention group receive telemedicine follow-up care in the community. The key ingredient in the intervention is the close integration between health care levels. The intervention is facilitated by the use of an interactive wound platform consisting of a Web-based ulcer record combined with a mobile phone, enabling counseling and communication between nurses in the community and specialist health care. Patients in the control group receive standard hospital outpatient care. The primary endpoint in the trial is healing time; secondary outcomes include amputation and death, patient-reported outcome measures, and follow-up data on the recurrence of foot ulcers. In addition, qualitative substudies are being performed to provide a more comprehensive evaluation of the ongoing processes during the trial with the patients in the intervention and control groups and those health care professionals either working in primary care or in specialist care delivering the intervention. RESULTS: The project has been funded. The inclusion of patients started in September 2012. Because recruitment goals were not met in the initial period, two more clinical sites have been included to meet sample size requirements. Patient recruitment will continue until June 2016. Data collection in the qualitative substudies has been completed. CONCLUSIONS: This telemedicine trial operates in a novel setting and targets patients with diabetes-related foot ulcers during a 12-month follow-up period. The trial addresses whether integrated care using telemedicine between primary and specialist health care can be an equivalent alternative to standard outpatient care. TRIAL REGISTRATION: ClinicalTrials.gov NCT01710774; https://clinicaltrials.gov/ct2/show/NCT01710774 (Archived by WebCite at http://www.webcitation.org/6im6KfFov).

Cross-border flow of health information: is 'privacy by design' enough? Privacy performance assessment in EUBIROD.

BACKGROUND: The EUBIROD project aims to perform a cross-border flow of diabetes information across 19 European countries using the BIRO information system, which embeds privacy principles and data protection mechanisms in its architecture (privacy by design). A specific task of EUBIROD was to investigate the variability in the implementation of the EU Data Protection Directive (DPD) across participating centres. METHODS: Compliance with privacy requirements was assessed by means of a specific questionnaire administered to all participating diabetes registers. Items included relevant issues e.g. patient consent, accountability of data custodian, communication (openness) and complaint procedures (challenging compliance), authority to disclose, accuracy, access and use of personal information, and anonymization. The identification of an ad hoc scoring system and statistical software allowed an overall quali-quantitative analysis and independent evaluation of questionnaire responses, automated through a dedicated IT platform ('privacy performance assessment'). RESULTS: A total of 18 diabetes registers from different countries completed the survey. Over 50% of the registers recorded a maximum score for accountability, openness, anonymization and challenging compliance. Low average values were found for disclosure and disposition, access, consent, use of personal information and accuracy. A high heterogeneity was found for anonymization, consent, accuracy and access. CONCLUSIONS: The novel method of privacy performance assessment realized in EUBIROD may improve the respect of privacy in each data source, reduce overall variability in the implementation of privacy principles and favour a sound and legitimate cross-border exchange of high quality data across Europe.

Within-subject biological variation of glucose and HbA(1c) in healthy persons and in type 1 diabetes patients.

BACKGROUND: Several articles describing within-subject biological variation of fasting glucose and HbA(1c) in healthy populations have been published, but information about biological variation of glucose and HbA(1c) in patients with type 1 diabetes is scarce. It is reasonable to assume that type 1 diabetics differ from their healthy counterparts in this matter. The aim of our study was to estimate the biological variation of glucose and HbA(1c) in healthy subjects and in patients with type 1 diabetes. METHODS: Fifteen healthy individuals and 15 type 1 diabetes patients were included. Biological variations were calculated based on blood samples collected weekly for 10 consecutive weeks from the healthy and the eligible of the type 1 diabetes patients. RESULTS: The within-subject variations of glucose were approximately 5% in healthy individuals and 30% in diabetes patients, and for HbA(1c) they were 1.2% in healthy individuals and 1.7% in diabetes patients. CONCLUSIONS: In conclusion, we found a high within-subject biological variation of glucose in diabetes patients as expected compared to healthy individuals (30% vs. 5%). The short-term (2 months) within-subject biological variation of HbA(1c) did not differ significantly between well regulated type 1 diabetes patients and healthy individuals (1.7% vs. 1.2%).

Six-month preoperative octreotide treatment in unselected, de novo patients with acromegaly: effect on biochemistry, tumour volume, and postoperative cure.

OBJECTIVE: Treatment with somatostatin analogues is the primary medical treatment of acromegaly. Controversies still exist whether acute octreotide effect predicts long-term biochemical effects, tumour regression or surgical cure. This prospective study investigates effect of 6-month treatment with octreotide long-acting repeatable (LAR) on insulin-like growth factor-1 (IGF-1) and growth hormone (GH) levels, pituitary function, tumour regression and postoperative cure in de novo acromegalic patients. DESIGN AND METHODS: After a baseline evaluation including fasting hormone levels, MRI scan and an acute 50 µg octreotide test, 32 patients were treated with octreotide LAR 20 mg every 28th day for 6 months before surgery. Treatment effects on IGF-1 and GH levels, serum hormone levels and tumour volume were monitored. Surgical cure was evaluated 3 months postoperatively. RESULTS: Mean tumour volume reduction was 35%, in one-third of the patients more than 50%, while approximately one-third achieved biochemical remission evaluated by normalized IGF-1 levels. The GH reduction following an acute octreotide test was 81 ± 19% and associated with long-term GH reduction (r = 0·78, P < 0·0005). However, neither acute (r = 0·29, P = 0·12) nor the long-term octreotide effect (r = 0·11, P = 0·58) on GH levels was associated with tumour volume reduction and did not predict subsequent surgical cure. CONCLUSION: Six months of long-acting octreotide using a fixed dose, 1/3 of the patients came in biochemical remission, while 2/3 had significant tumour reduction. Moreover, an acute effect of octreotide seemed to be a prerequisite for long-term effect.

Six months of diazoxide treatment at bedtime in newly diagnosed subjects with type 1 diabetes does not influence parameters of {beta}-cell function and autoimmunity but improves glycemic control.

OBJECTIVE Continuous beta-cell rest with diazoxide preserves residual endogenous insulin production in type 1 diabetes. However, side effects have hampered therapeutic usefulness. In a double-blind study, we tested whether lower, intermittent dosing of diazoxide had beneficial effects on insulin production, metabolic control, and autoimmunity markers in the absence of side effects. RESEARCH DESIGN AND METHODS Forty-one newly diagnosed type 1 diabetic patients were randomized to 6 months of treatment with placebo or 100 mg diazoxide at bedtime. A1C, C-peptide (fasting and glucagon stimulated), and FoxP3(+) regulatory T-cells (Tregs) were measured. Patients were followed for 6 months after intervention. RESULTS Of six dropouts, three were due to perceived side effects; one subject in the diazoxide group experienced rash, another dizziness, and one in the placebo group sleep disturbance. Adverse effects in others were absent. Diazoxide treatment reduced A1C from 8.6% at baseline to 6.0% at 6 months and 6.5% at 12 months. Corresponding A1C value in the placebo arm were 8.3, 7.3, and 7.5% (P < 0.05 for stronger reduction in the diazoxide group). Fasting and stimulated C-peptide decreased during 12 months similarly in both arms (mean -0.30 and -0.18 nmol/l in the diazoxide arm and -0.08 and -0.09 nmol/l in the placebo arm). The proportion of Tregs was similar in both arms and remained stable during intervention but was significantly lower compared with nondiabetic subjects. CONCLUSIONS Six months of low-dose diazoxide was without side effects and did not measurably affect insulin production but was associated with improved metabolic control.

Self-monitoring of blood glucose in type 1 diabetes patients with insufficient metabolic control: focused self-monitoring of blood glucose intervention can lower glycated hemoglobin A1C.

OBJECTIVE: Little attention has been given and few studies have been published focusing on how to optimize self-monitoring of blood glucose (SMBG) use to monitor daily therapy for persons with type 1 diabetes mellitus. This study was designed to evaluate the effect on glycated hemoglobin (A1C) of a structured intervention focused on SMBG in type 1 diabetes patients with insufficient metabolic control (A1C ≥8%) using a randomized clinical trial design. METHOD: One hundred fifty-nine outpatients with type 1 diabetes on multiple injection therapy with insulin and A1C ≥8% were recruited and randomized to one group receiving a focused, structured 9-month SMBG intervention (n=59) and another group receiving regular care based on guidelines (n=64). RESULTS: Glycated hemoglobin values (mean % ± standard deviation) at study start was similar: 8.65 ± 0.10 in the intervention group and 8.61 ± 0.09 in the control group. The two groups were comparable (age, gender, body mass index, complication rate, and treatment modality) at study start and had mean diabetes duration and SMBG experience of 19 and 20 years, respectively. At study end, there was decrease in A1C in the intervention group (p<.05), and the A1C was 0.6% lower compared with the control group (p<.05). No increase in the number of minor or major hypoglycemia episodes was observed in the intervention group during the study period. CONCLUSIONS: A simple, structured, focused SMBG intervention improved metabolic control in patients with longstanding diabetes type 1 and A1C ≥8%. The intervention was based on general recommendations, realistic in format, and can be applied in a regular outpatient setting.

Standardized evaluation of nine instruments for self-monitoring of blood glucose.

BACKGROUND: Instruments for self-monitoring of blood glucose (SMBG) should undergo a standardized evaluation including a user-test before being marketed. In this study the results from standardized evaluations of nine different SMBG instruments are presented, and the standardized evaluation is discussed. METHODS: Approximately 80 diabetes patients using three lots of test strips participated in each evaluation. Half of the patients were educated in how to use the meter, and the evaluations were carried out by both medical laboratory technologists (MLTs) and patients. Questionnaires were used to assess the user manual and the user-friendliness of the instrument. RESULTS: The imprecision obtained by the patients (coefficients of variation [CVs] of 3.2-8.1%) were generally higher compared to that by the MLT (CVs of 2.3-5.9%). Three of the nine instruments did not achieve the quality goal based on the recommendation in the International Organization for Standardization's ISO 15197 guideline in the hands of diabetes patients. The bias from the comparison method ranged from -10.4% to +3.2%. There were significant lot-to-lot variations and hematocrit effects for some of the instruments. Temperature difference between the instruments and the test strip caused deterioration of the quality in one instrument. The user-friendliness was in general acceptable. CONCLUSIONS: The quality of instruments for SMBG seems to have improved during recent years, although there are still analytical problems. A standardized evaluation protocol is necessary and should be regularly revised taking into account the development of new technology and the needs of the patients.

[Insulin infusion for critically ill patients]. / Insulininfusjon til pasienter med akutt kritisk sykdom.

BACKGROUND: Stress, acute illness and surgery are known to increase blood sugar. Hyperglycaemia in critically ill patients is associated with increased mortality irrespective of diabetes status. The effect of treating critically ill patients with insulin infusions has been assessed in many randomised trials in recent years. Possible mechanisms related to hyperglycaemia and the effects of insulin have also been studied. MATERIAL AND METHODS: The present review is based on a systematic Medline search, references in key articles, and our personal clinical experience. RESULTS: The effect of reducing blood glucose to normal levels is best documented in patients with myocardial infarction and in those receiving intensive care. Insulin therapy should be considered when plasma glucose levels exceed 8 mmol/L; the treatment target is 4-6 mmol/L. There is a low risk of serious hypoglycaemia according to our experience, but systematic monitoring of blood glucose is important. INTERPRETATION: Insulin therapy is an inexpensive and safe way to improve outcome in critically ill patients. Insulin infusions should therefore be used more to treat hyperglycaemia in critically ill hospitalized patients, especially in coronary care- and intensive care units.

Postanalytical external quality assessment of blood glucose and hemoglobin A1c: an international survey.

BACKGROUND: Diabetes mellitus (DM) is diagnosed and monitored worldwide by blood glucose (BG) and glycohemoglobin A(1c) (HbA(1c)) testing, respectively. Methods for quality assessment of clinician interpretations of changes in these laboratory results have been developed. This study uses survey responses from general practitioners (GPs) in different countries to investigate possible differences in interpretation of results, as well as the feasibility of performing international postanalytical external quality assessment surveys (P-EQAS). METHODS: GPs recruited from 7 countries received questionnaires requesting interpretation of changes in a potentially diagnostic capillary BG result and an HbA(1c) value obtained during monitoring of a patient with type 2 DM. GPs were asked to estimate clinically significant differences between 2 consecutive laboratory results [critical difference (CD)/reference change value] for both BG and HbA(1c). The CDs reported by GPs were used to calculate the analytical variation (CV(a)), which was taken as the quality specification for analytical imprecision. Participants received national benchmarking feedback reports after the survey. RESULTS: The study included responses from 2538 GPs. CDs in BG results showed the same pattern and were comparable among countries. Calculated median CV(a) values would be possible to attain at 80% confidence but not at the conventional 95% confidence. For HbA(1c), the same pattern was shown across countries, but with lower changes considered true when HbA(1c) increased than when it decreased. Despite the consistent pattern, variations among GPs were considerable in all countries. CONCLUSIONS: Assessments of CDs for BG and HbA(1c) were similar internationally, and quality specifications for these analytes based on clinicians' opinions are therefore interchangeable among countries. International P-EQAS may contribute to a more rational use of laboratory services and clinical guidelines.

[Prevalence of diabetes mellitus in Norway]. / Hvor mange har diabetes mellitus i Norge?

BACKGROUND: Our aim was to combine several regional studies in order to estimate the prevalence of diabetes in Norway. MATERIAL AND METHODS: We used data from a nation-wide registration of type 1 diabetes in the age group < 30 years. Data for other age groups were taken from nine regional surveys, of which six were repeated. The average prevalence of known diabetes based on self-administered questionnaires was estimated. Data on previously undiagnosed diabetes were available from two Norwegian studies and from other countries. RESULTS: The sex and age standardised prevalence of "known" diabetes (all age groups) was estimated at 2.3%, increasing with age to approximately 8% among the 70 to 79-year-olds. The prevalence was 3.4% among those aged > or =30 years. The estimated increase in prevalence of known diabetes over time was 1.4% per calendar year, with variation between sub-groups. The number of unknown cases may be nearly equal to the number of known cases in the age-groups > or =30 years, but this is uncertain. INTERPRETATION: There are probably about 90,000 to 120,000 people with diagnosed diabetes in Norway. Nearly as many may have undiagnosed diabetes, but this is uncertain. Studies representative of the Norwegian population using the oral glucose tolerance test are needed.

Insulin detemir is associated with more predictable glycemic control and reduced risk of hypoglycemia than NPH insulin in patients with type 1 diabetes on a basal-bolus regimen with premeal insulin aspart.

OBJECTIVE: Insulin detemir is a soluble basal insulin analog with a unique mechanism of protracted action designed to reduce the variability associated with conventional basal insulins. This trial compared the glycemic control, risk of hypoglycemia, and effect on body weight of insulin detemir and NPH insulin in patients with type 1 diabetes treated with rapid-acting insulin aspart at meals. RESEARCH DESIGN AND METHODS: This study was a 6-month multinational open parallel-group comparison conducted at 46 centers in five countries and included 448 patients with type 1 diabetes randomized 2:1 to insulin detemir or NPH insulin, respectively. RESULTS: After 6 months, comparable HbA(1c) levels were found between the two treatment groups. Fasting plasma glucose tended to be lower in patients treated with insulin detemir, but this difference was not statistically significant (-0.76 mmol/l, P = 0.097). Within-subject variation in self-measured fasting blood glucose was lower with insulin detemir than with NPH insulin (SD 3.37 vs. 3.78 mmol/l, P < 0.001). Risk of hypoglycemia was 22% lower with insulin detemir than with NPH insulin (P < 0.05) and 34% lower for nocturnal (2300-0600) hypoglycemia (P < 0.005). Nightly plasma glucose profiles were smoother and more stable with insulin detemir (P = 0.05). Body weight was significantly lower with insulin detemir at the end of the trial (P < 0.001). CONCLUSIONS: Treatment with insulin detemir resulted in more predictable glycemic control, with smoother plasma glucose profiles than NPH insulin and a significant reduction in the risk of hypoglycemia. The reduction in body weight with insulin detemir is a potential additional advantage. Regimens optimized for insulin detemir may be able to improve glycemic control beyond that possible with NPH insulin.