Svein Skeie

Insulin detemir used in basal-bolus therapy in people with type 1 diabetes is associated with a lower risk of nocturnal hypoglycaemia and less weight gain over 12 months in comparison to NPH insulin.

Aim:  The aim of this study was to compare the long‐term safety and efficacy of twice‐daily insulin detemir or NPH insulin as the basal component of basal‐bolus therapy in people with type 1 diabetes.

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 Standardizations 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.

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.

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

Abstract Background: Several articles describing within-subject biological variation of fasting glucose and HbA1c in healthy populations have been published, but information about biological variation of glucose and HbA1c 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 HbA1c 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 HbA1c 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 HbA1c did not differ significantly between well regulated type 1 diabetes patients and healthy individuals (1.7% vs. 1.2%).

Privacy impact assessment in the design of transnational public health information systems: the BIRO project

Objectives: To foster the development of a privacy-protective, sustainable cross-border information system in the framework of a European public health project. Materials and methods: A targeted privacy impact assessment was implemented to identify the best architecture for a European information system for diabetes directly tapping into clinical registries. Four steps were used to provide input to software designers and developers: a structured literature search, analysis of data flow scenarios or options, creation of an ad hoc questionnaire and conduction of a Delphi procedure. Results: The literature search identified a core set of relevant papers on privacy (n = 11). Technicians envisaged three candidate system architectures, with associated data flows, to source an information flow questionnaire that was submitted to the Delphi panel for the selection of the best architecture. A detailed scheme envisaging an “aggregation by group of patients” was finally chosen, based upon the exchange of finely tuned summary tables. Conclusions: Public health information systems should be carefully engineered only after a clear strategy for privacy protection has been planned, to avoid breaching current regulations and future concerns and to optimise the development of statistical routines. The BIRO (Best Information Through Regional Outcomes) project delivers a specific method of privacy impact assessment that can be conveniently used in similar situations across Europe.

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

OBJECTIVE Continuous β-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.

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).

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.

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.

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.