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1.
Diabet. Med. 29, e369-e376 (2012) ABSTRACT: Aims To assess physical activity and fitness levels of young people with Type?1 diabetes compared with siblings without diabetes, and to investigate the association between physical activity, physical fitness and glycaemic control (HbA(1c) ) in those young people with diabetes. Methods The study consisted of 97 young people aged 8 to 16?years (62% male) from a Paediatric Diabetes Service in South West England. Sixty participants (67% male) had Type?1 diabetes and 37 participants (54% male) were siblings without diabetes (control group). We measured weight, height and waist circumference, calculated BMI and waist-height ratio and recorded pubertal status, blood pressure and current insulin regimen information. We assessed physical activity by accelerometry, from which we calculated light and moderate-to-vigorous intensity activity. We measured physical fitness by multistage sub-maximal bicycle ergometer test. We obtained HbA(1c) by venipuncture. Results There were no differences between the young people with diabetes and siblings without diabetes in body composition, blood pressure, physical activity and fitness. Moderate-to-vigorous physical activity was associated with better glycaemic control, accounting for 30-37% (R(2) =?0.295-0.374) of the variance for HbA(1c) . Physical fitness was not associated with HbA(1c.) Conclusions Moderate-to-vigorous physical activity was associated with better glycaemic control while fitness was not. Findings suggest that developing strategies to increased moderate-to-vigorous physical activity may prove an effective method of improving glycaemic control in young people with diabetes.  相似文献   

2.

Background and Aims

Previous studies have investigated the association between ethnicity and processes of care and intermediate outcomes of diabetes, but there are limited population-based studies available. The aim of this study was to use population-based data to investigate the relationships between ethnicity and glycaemic control in men and women with diabetes mellitus living in Scotland

Methods

We used a 2008 extract from the population-based national electronic diabetes database of Scotland. The association between ethnicity with mean glycaemic control in type 2 diabetes mellitus was examined in a retrospective cohort study, including adjustment for a number of variables including age, sex, socioeconomic status, body mass index (BMI), prescribed treatment and duration of diabetes.

Results

Complete data for analyses were available for 56,333 White Scottish adults, 2,535 Pakistanis, 857 Indians, 427 Chinese and 223 African-Caribbeans. All other ethnic groups had significantly (p<0.05) greater proportions of people with suboptimal glycaemic control (HbA1c >58 mmol/mol, 7.5%) compared to the White Scottish group, despite generally younger mean age and lower BMI. Fully adjusted odds ratios for suboptimal glycaemic control were significantly higher among Pakistanis and Indians (1.85, 95% CI: 1.68–2.04, and 1.62,95% CI: 1.38–1.89) respectively.

Conclusions

Pakistanis and Indians with type 2 diabetes mellitus were more likely to have suboptimal glycaemic control than the white Scottish population. Further research on health services and self-management are needed to understand the association between ethnicity and glycaemic control to address ethnic disparities in glycaemic control.  相似文献   

3.
This study compares the prevalence of chronic complications, the quality of metabolic control and the nutritional intake in people with type 1 diabetes in different European regions. The EURODIAB Complications Study included a sample of 3250 European patients with type 1 diabetes stratified for gender, age and diabetes duration. All examinations were performed using standardised, validated methods. HBA1c, LDL-cholesterol and fasting triglycerides were higher in the eastern European centres than in the southern or north-western European centres. Acute (severe ketoacidosis, severe hypoglycaemia) and chronic diabetes complications (retinopathy, nephropathy, neuropathy, cardiovascular disease) were all considerably more frequent in the eastern European centres. HbA1c was lower in the German centres than in the total EURODIAB cohort or in the north-western European centres, but severe hypoglycaemia and proliferative retinopathy were more common. Persons from the eastern European and the German centres consumed undesirably high amounts of cholesterol, total and saturated fat. Overall, improvements in the prevention, detection and management of diabetes complications in persons with type 1 diabetes are essential throughout Europe, particularly in eastern European regions. Since elevated LDL-cholesterol levels and hypertension were strikingly common in this relatively young cohort of European people with type 1 diabetes, generally more attention should be directed towards an adequate management of these cardiovascular risk factors.  相似文献   

4.
AimsTo investigate young people’s attitudes to, and understanding of, physical activity on glycaemic control in Type 1 Diabetes Mellitus.MethodsFour focus groups with 11–14 and 15–16 year olds were conducted with twelve young people with Type 1 Diabetes, from within a larger study investigating physical activity and fitness. Qualitative analysis of the focus group data was performed using Interpretative Phenomenological Analysis.ResultsFour superordinate themes were identified: Benefits of Exercise, Knowledge and Understanding, Information and Training and “You can do anything”. Young people felt that exercising helped them to manage their diabetes and had a beneficial psychological and physical impact on their bodies. They reported a lack of knowledge and understanding about diabetes among school staff and other young people. The overwhelming sense from young people was that although diabetes impacts upon their lives, with preparation, physical activity can take place as normal.ConclusionsWhilst young people had an awareness of the physical and psychological benefits of exercise in managing their diabetes, they experienced difficulties at school. Professional support and discussions with young people, giving tailored strategies for managing Type 1 Diabetes during exercise are needed. Healthcare teams should ensure that the support and educational needs of school staff are met. Providing more opportunities to empower young people to take on the responsibility for their Type 1 Diabetes care is merited. Young people felt diabetes did not stop them from participating in activities; it is simply a part of them that needs managing throughout life.  相似文献   

5.
The dietary management of childhood diabetes is complex. Is it possible to educate young people to balance carbohydrate with their insulin? Can dietary knowledge be translated into lasting behaviour change? Do present teaching methods provide the skills necessary for children and parents to adjust their insulin therapy adequately? Evidence shows great variation in glycaemic control between centres and countries but the impact of dietary education methods is poorly evaluated and its links with clinical and psychosocial outcomes is virtually unknown. There is also little evidence to suggest cohesive teamworking with clear dietary targets for glycaemic control, lipids, incidence of hypoglycaemia, compliance, effect on peer and sibling relationships, and evaluation of individual dietary components, e.g. fibre, fat, antioxidants. There is wide variation in methods of dietary education, which are often based on historic practice. They include rigid counting of grams of carbohydrate, carbohydrate portion assessments, qualitative diets, low glycaemic index diets and the more recent 'intensified' carbohydrate measures with daily adjustments of insulin (the basis also of pump management). This last method has many benefits although it requires extensive nutrition education, it allows greater flexibility and variety of food intake, is sensitive to the varying daily energy expenditure of childhood and it addresses postprandial glycaemic excursions, all of which are inadequately managed by conventional therapy. However, one of the problems of overemphasizing carbohydrate measurement is that total carbohydrate intake may be suppressed, with a resulting increase in fat, this may contribute to an increase in cardiovascular risk. The ISPAD Consensus Guidelines 2000 contain dietary recommendations but scientific evidence is often lacking. Limited dietary studies show that some countries can meet guidelines more successfully than others. There are many reasons for this, such as food availability, types of food eaten, food preferences and family/cultural/religious influences. Educational methods must be adapted to local customs. Is there enough evidence to recommend a particular dietary education method? What outcomes do we hope to achieve? The workshop explored these issues in order to develop a deeper understanding of the complexity of dietary modification in childhood diabetes.  相似文献   

6.
Hypoglycaemia is particularly common in young children with type 1 diabetes mellitus yet the normal protective counterregulatory responses have been little studied in this age group. The studies reported have shown conflicting results, in part related to prior glycaemic control and also to the method of investigation used. Counterregulatory hormone responses during both spontaneous and experimentally induced episodes of nocturnal hypoglycaemia do appear to be blunted, which may be a function of sleep itself. Although studies of cognitive function have consistently shown defects in certain areas of neurocognitive performance, particularly in those children with early-onset diabetes or a prior history of severe hypoglycaemia, the contribution of nocturnal hypoglycaemia to the development of these impairments has not been evaluated. In young adults and adolescents, nocturnal hypoglycaemia has been linked to cardiac arrhythmia and the risk of sudden death. The development of new techniques for continuous subcutaneous glucose monitoring may allow detailed study of counterregulatory responses and symptom recognition in young children. Effective intensification of insulin therapy without an increased risk of hypoglycaemia may be possible using new insulin analogues or continued subcutaneous intravenous infusion (CSII), thus improving patient compliance and overall quality of clinical care.  相似文献   

7.
OBJECTIVE--To assess patient, doctor, practice, and process of care variables for their effect on glycaemic control in diabetes mellitus, and to quantify their relative effects. DESIGN--Search of general practice medical records, patient questionnaires and examination, doctor questionnaire, videotaping and analysis of consultations, and practice questionnaire. SETTING--12 practices with 32 participating general practitioners in Nottinghamshire. SUBJECTS--318 patients randomly selected from those with diabetes in each practice, 10 for each participating doctor. MAIN OUTCOME MEASURE--Glycaemic control as measured by random glycated haemoglobin A1c estimation (random haemoglobin A1 measurement). RESULTS--Glycaemic control was significantly related to the disease process as measured by years since diagnosis, treatment group, and number of diabetes related clinical events. Females had significantly worse control than males. Other patient factors, such as age, social class, lifestyle, attitudes, satisfaction, and knowledge, had no association with glycaemic control. Of all the doctor factors examined, only doctors who professed a special interest in diabetes achieved significantly better glycaemic control. Bigger and better equipped practices and those with a diabetic miniclinic had patients with significantly better glycaemic control, as did those with access to dietetic advice. Patients attending hospital clinics had worse glycaemic control, but this seemed to be attributable to the case mix and practice characteristics. Shared care did not contribute to the multiple linear regression model. CONCLUSION--Glycaemic control among diabetic patients in the community is related to such factors as treatment group, sex, and years since diagnosis; it is also related to the organisation and process of care. The findings support concentrating diabetic care on partners with special interests in diabetes in well equipped practices with adequate dietetic support.  相似文献   

8.
Diabet. Med. 29, e382-e389 (2012) ABSTRACT: Aims To investigate the association between glycaemic control and patient socio-demographics, activation level, diabetes-related distress, assessment of care, knowledge of target HbA(1c) , and self-management behaviours, and to determine to what extent these factors explain the variance in HbA(1c) in a large Danish population of patients with Type 2 diabetes. Methods Cross-sectional survey and record review of 2045 patients from a specialist diabetes clinic. Validated scales measured patient activation, self-management behaviours, diabetes-related emotional distress, and perceived care. The electronic patient record provided information about HbA(1c) , medication, body mass index, and duration of diabetes. Data were analysed using multiple linear regression models with stepwise addition of covariates. Results The response rate was 54% (n?=?1081). Good glycaemic control was significantly associated with older age, higher education, higher patient activation, lower diabetes-related emotional distress, better diet and exercise behaviours, lower body mass index, shorter duration of disease and knowledge of HbA(1c) targets (P?相似文献   

9.
Diabetes and hypertension are much more prevalent among Britain''s 2.5 million Asian and African-Caribbean population than among the white population and are major contributors to end stage renal failure. Asians and African-Caribbeans have threefold to fourfold higher acceptance rates on to renal replacement therapy than white people, and in some districts they comprise up to half of all patients receiving such treatment. Their greater need for renal replacement treatment is accompanied by difficulties of tissue matching in cross racial transplants and a shortage of donor organs. The aging of ethnic minority populations will increase local need for renal services significantly. Measures to control diabetes, hypertension, and secondary complications in Asian and African-Caribbean communities will contribute both to safeguarding health and to economies in spending on renal services. Education about diabetes and hypertension, modification of behavioural risk factors, early diagnosis, effective glycaemic and blood pressure control, and early referral for signs of renal impairment are essential preventive measures. Primary and community health care professionals have a critical role to play here.  相似文献   

10.

Background

The clinical features of type 2 diabetes may differ depending on whether first depression episode precedes or follows the diagnosis of diabetes.

Methods

Type 2 patients from the observational community-based Fremantle Diabetes Study Phase II underwent assessment of lifetime depression using the Brief Lifetime Depression Scale (developed and validated for this study) supplemented by information on current depression symptoms (Patient Health Questionnaire, 9-item version) and use of antidepressants. Patients were categorized as never depressed (Group 1), having had depression before diabetes diagnosis (Group 2), diagnosed with depression and diabetes within 2 years of each other (Group 3) and having depression after diabetes diagnosis (Group 4).

Results

Of 1391 patients, 20.8% were assigned to Group 2, 6.0% to Group 3 and 14.5% to Group 4. In Group 2, depression occurred a median 15.6 years before diabetes onset at age 37.2±14.7 years. These patients had similar clinical characteristics to never depressed patients except for reduced self-care behaviours and having more symptomatic peripheral arterial disease. In Group 4, depression occurred a median 9.9 years after diabetes onset at age 59.8±13.0 years. These patients had long duration diabetes, poor glycaemic control, more intensive management and more diabetic complications. Group 4 patients had more current depression than Group 2 but were less likely to be receiving antidepressants.

Conclusions/Interpretation

The clinical features of depression and type 2 diabetes are heterogeneous depending on their temporal relationship. There may be corresponding differences in the pathogenesis of depression in diabetes that have implications for diagnosis and management.  相似文献   

11.
ABSTRACT: BACKGROUND: World-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs) rather than hospital specialists. Intermediate care clinics for diabetes (ICCD) potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1) compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2) assess the cost-effectiveness of the intervention; and (3) explore the views and experiences of patients, health professionals and other stakeholders. METHODS: This two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study) is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention) or to hospital care (control).Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice.orControl group: Standard GP care, with referral to secondary care as required, but no access to ICCD.Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (<=7.0%); blood pressure (<140/80); and cholesterol (<4 mmol/l), at the end of the 18-month intervention period. The main secondary outcomes are the proportion of participants reaching individual risk factor targets and the overall 10-year risks for coronary heart disease(CHD) and stroke assessed by the United Kingdom Prospective Diabetes Study (UKPDS) risk engine. Other secondary outcomes include body mass index and waist circumference, use of medication, reported smoking, emotional adjustment, patient satisfaction and views on continuity, costs and health related quality of life. We aimed to randomize 50 practices and recruit 2,555 patients. DISCUSSION: Forty-nine practices have been randomized, 1,997 patients have been recruited to the trial, and 20 patients have been recruited to the qualitative study. Results will be available late 2012.Trial registration[ClinicalTrials.gov: Identifier NCT00945204].  相似文献   

12.
《Endocrine practice》2019,25(7):729-765
The American Association of Clinical Endocrinologists (AACE) has created a transculturalized diabetes chronic disease care model that is adapted for patients across a spectrum of ethnicities and cultures. AACE has conducted several transcultural activities on global issues in clinical endocrinology and completed a 3-city series of conferences in December 2017 that focused on diabetes care for ethnic minorities in the U.S. Proceedings from the “Diabetes Care Across America” series of transcultural summits are presented here. Information from community leaders, practicing health care professionals, and other stakeholders in diabetes care is analyzed according to biological and environmental factors. Four specific U.S. ethnicities are detailed: African Americans, Latino/Hispanics, Asian Americans, and Native Americans. A core set of recommendations to culturally adapt diabetes care is presented that emphasizes culturally appropriate terminology, transculturalization of white papers, culturally adapting clinic infrastructure, flexible office hours, behavioral medicine—especially motivational interviewing and building trust—culturally competent nutritional messaging and health literacy, community partnerships for care delivery, technology innovation, clinical trial recruitment and retention of ethnic minorities, and more funding for scientific studies on epigenetic mechanisms of cultural impact on disease expression. It is hoped that through education, research, and clinical practice enhancements, diabetes care can be optimized in terms of precision and clinical outcomes for the individual and U.S. population as a whole.Lay AbstractThe American Association of Clinical Endocrinologists (AACE) has created a diabetes care model for patients of different backgrounds. AACE led meetings in New York, Houston, and Miami with health care professionals and community leaders to improve diabetes care. Information from these meetings looked at biological and environmental diabetes risks. Four American patient groups were studied: African Americans, Latinos, Asian Americans, and Native Americans. Diabetes care should use culturally appropriate language and search for better ways to apply science and clinic design. Talking to patients more clearly can improve their diabetes control. There are many other needed changes in the American health care system discussed in this paper. It is hoped that through better education, research, and practice, diabetes care can be improved for the entire U.S. population. This means that important differences among patients' ethnic and cultural backgrounds are addressed.Executive Summary
  • Cultural adaptation of evidence-based recommendations is a necessary component of optimal diabetes care.
  • Biological factors that contribute to the pathophysiology of diabetes vary according to race and ethnicity and can be affected by social determinants that vary with culture.
  • The “Transcultural Diabetes Nutrition Algorithm” was developed in 2010 to optimize diabetes nutrition care globally and represents a validated methodology where evidence-based recommendations from a source culture can be adapted and implemented in a different culture using a toolkit.
  • The 2015 AACE Pan-American Workshop examined diabetes care in 9 Latin American nations and concluded that there should only be one level of diabetes care for a population and that level should be “excellent;” also, that A1C measurements should be utilized and that more educational and nutritional options are needed to optimize diabetes care.
  • The “Diabetes Care Across America – A Series of Transcultural Summits” was an AACE program conducted in 2017 in New York, Houston, and Miami to examine cultural factors that influence diabetes care domestically; the findings of this program are presented here.
  • The African American, Hispanic/Latino, Asian American, and Native American populations are each comprised of different ancestries, anthropometrics/body compositions and physical appearances, and cultures and degrees of acculturation, with a significant evidence base that associates specific gene variants with specific phenotypic traits affecting diabetes care.
  • For each ethno-cultural population, health messaging and diabetes care will need to consider issues of potential distrust of health care professionals, history of discrimination, religious practices, food preferences, attitudes toward physical activity, and despite the full range of socio-economics, the impact of poverty on engagement, self-monitoring, adherence with lifestyle and medical recommendations, and recruitment for clinical trials.
  • Diabetes care should be as precise as possible, incorporating clinical trial evidence that best reflects the ethno-cultural attributes of a specific patient, with particular emphasis on cardiovascular disease risk mitigation, technology to assess the effects of eating patterns on glycemic status, adjusting traditional eating patterns to more healthy options that are still acceptable to the patient, flexibility in lifestyle and medication recommendations that take into account cultural factors, and the utilization of community-based resources to improve implementation.
  • Pragmatic first steps to prepare a diabetes practice for an ethno-culturally diverse patient population include: learning more about biological-cultural interactions; gaining experience with lifestyle and behavioral medicine, especially motivational interviewing; creating a safe and immersive clinical environment; incorporating translation services, social prescribing, wearable technologies, web-based resources, and community engagement; and establishing referral networks with clinical trialists in diabetes research to improve recruitment of different populations.
ABSTRACTAbbreviations: A1C = hemoglobin A1c; AACE = American Association of Clinical Endocrinologists; ABCD = adiposity-based chronic disease; BMI = body mass index; CPA = clinical practice algorithm; CPG = clinical practice guideline; DBCD = dysglycemia-based chronic disease; DPP = Diabetes Prevention Program; GWAS = genome-wide association study; HCP = health care professional(s); IHS = Indian Health Service; LDL = low-density lipoprotein; MetS = metabolic syndrome; T2D = type 2 diabetes mellitus; tDNA = transcultural Diabetes Nutrition Algorithm; TG = triglyceride; WC = waist circumference  相似文献   

13.
These Joint British Diabetes Societies guidelines, commissioned by NHS Diabetes, for the perioperative management of the adult patient undergoing surgery are available in full in the Supporting Information. This document goes through the seven stages of the patient journey when having surgery. These are: primary care referral; surgical outpatients; preoperative assessment; hospital admission; surgery; post-operative care; discharge. Each stage is given its own considerations, outlining the roles and responsibilities of each group of healthcare professionals. The evidence base for the recommendations made at each stage, discussion of controversial areas and references are provided in the report. This document has two key recommendations. Firstly, that the management of the elective adult surgery patients should be with modification to their usual diabetes treatment if the fasting is minimized because the routine use of a variable rate intravenous insulin infusion is not recommended. Secondly, that poor preoperative glycaemic control leads to post-outcomes and thus, where appropriate, needs to be addressed prior to referral for surgery.  相似文献   

14.
This paper discusses the new national guidelines for a systematic screening programme to detect sight-threatening diabetic retinopathy in the population of people with diabetes in England. A review of the literature examines the evidence base to support screening interventions and effective management and treatments in diabetic retinopathy. The current evidence supports the establishment of a digital retinal photography system using pupil dilation. A Policy Advisory Group has been formulated by the National Screening Committee to guide the meeting of this target in England. A conclusion is made that with increased effort and organisation, health care professionals can ensure that the screening programme is successfully implemented and rates of visual impairment and blindness caused by diabetic retinopathy can be reduced significantly.  相似文献   

15.
16.
Much of the current genetic research into aggressive and violent behavior focuses on young people and might appear to offer the hope of targeted prediction and intervention. In the UK data are collected on children from various agencies and collated to produce “at risk of offending” identities used to justify intervention. Information from behavioral genetic tests could conceivably be included. Regulatory frameworks for collecting, storing and using information from DNA samples differ between the health service and the police particularly in the need for consent and the treatment of children. This paper draws on discussions with professionals involved with “problem” young people to consider their views on the utility of genetic research for tackling violent/aggressive behavior and the impact an identification of genetic susceptibility might have on their clients.  相似文献   

17.
The national Quality Assurance for Aboriginal Medical Services (QAAMS) Program, in which point-of-care testing (POCT) for haemoglobin A(1c) (HbA(1c)) and urine albumin: creatinine ratio (ACR) is performed for diabetes management in 65 Australian Aboriginal medical services, is now embedded in the practice of diabetes care across Indigenous Australia. This paper documents the results of a detailed survey to assess levels of satisfaction with the QAAMS HbA(1c) Program among three key stakeholder groups-doctors, POCT operators and patients with diabetes. Both doctors and patients with diabetes agreed that the immediacy of POCT results contributed positively to patient care, improved the doctor-patient relationship, and made the patient more likely to be both compliant and self-motivated to improve their diabetes control. Both POCT operators and patients with diabetes reported improved satisfaction with their diabetes services after the introduction of POCT. The paper also provides evidence from two participating medical services that POCT has been an effective tool in improving the delivery of pathology services and clinical outcomes for both individuals and groups of patients with diabetes. A statistically significant reduction in HbA(1c) from 9.3% (+/- 2.0) to 8.6% (+/- 2.0) was observed in 74 diabetes patients 12 months after commencing POCT (p = 0.003, paired t-test). An improvement in the percentage of patients achieving glycaemic targets and a reduction in the percentage of patients with poor control was also observed in this group. These data provide evidence that the QAAMS POCT model delivers a culturally and clinically effective service for diabetes management in Aboriginal Australia.  相似文献   

18.
This paper discusses the new national guidelines for a systematic screening programme to detect sight-threatening diabetic retinopathy in the population of people with diabetes in England. A review of the literature examines the evidence base to support screening interventions and effective management and treatments in diabetic retinopathy. The current evidence supports the establishment of a digital retinal photography system using pupil dilation. A Policy Advisory Group has been formulated by the National Screening Committee to guide the meeting of this target in England. A conclusion is made that with increased effort and organisation, health care professionals can ensure that the screening programme is successfully implemented and rates of visual impairment and blindness caused by diabetic retinopathy can be reduced significantly. (Mol Cell Biochem 261: 183–185, 2004)  相似文献   

19.
Adequate age-appropriate diabetes knowledge and skills are essential to the success of diabetes self- and parental care. Health professionals have a central role in providing diabetes education. A direct link between diabetes knowledge and diabetes regimen behaviour cannot be assumed. Health professionals have to help children and their parents to develop the emotional concept of 'self-efficacy for diabetes self-care', to ensure optimal diabetes control.  相似文献   

20.
BACKGROUND: Newly diagnosed insulin-dependent diabetes mellitus is characterised by a temporary recovery of endogeneous insulin ("remission") after the beginning of medical treatment with subcutaneous insulin injections. Although most diabetologists think, that insulin reserve is related to reduced occurrence of diabetic long-term complications, such as eye, nerve and kidney disease, there is only one prospective controlled clinical study (the DCCT) addressing this question, however as secondary hypothesis. METHODS/DESIGN: Therefore, we composed a trial consisting of two cohorts with two therapeutic options within each cohort (conventional versus intensive therapy) and a three-year follow-up. In one group the patients are randomly assigned to the treatment regimes to test the statistical alternative hypothesis if variable insulin dosage is superior to fixed insulin injection in preserving insulin reserve measured by C-peptide in serum. Another group includes patients who prefer one of the two therapies, decline randomisation, but consent to follow-up. Apart from the determination of insulin reserve as a biological parameter a second primary endpoint was defined as 'therapeutic failure' according to the criteria of the European Association for the Study of Diabetes. Patients pass a training program to help them self-manage diabetes. A standardised protocol is being set up to minimize centre effects and bias of health care providers. Potential patient dependent bias will be investigated by questionnaires measuring psychic coping processes of people with diabetes. Management of visit dates is directly navigated by the database. Automated visit-reminders are mailed to patients and caregivers to optimise the number of visits on schedule. Data quality is regularly monitored and centres are informed on the results of continuous data management.  相似文献   

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