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- Brännholm Syrjälä, Maria, et al.
(författare)
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Health effects of reduced occupational sedentary behaviour in type 2 diabetes using a mobile health intervention : a study protocol for a 12-month randomized controlled trial—the ROSEBUD study
- 2022
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Ingår i: Trials. - : BioMed Central. - 1745-6215. ; 23:1
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Tidskriftsartikel (refereegranskat)abstract
- Background: Short-term trials conducted in adults with type 2 diabetes mellitus (T2DM) showed that reducing sedentary behaviour by performing regular short bouts of light-intensity physical activity enhances health. Moreover, support for reducing sedentary behaviour may be provided at a low cost via mobile health technology (mHealth). There are a wide range of mHealth solutions available including SMS text message reminders and activity trackers that monitor the physical activity level and notify the user of prolonged sitting periods. The aim of this study is to evaluate the effects of a mHealth intervention on sedentary behaviour and physical activity and the associated changes in health in adults with T2DM.Methods: A dual-arm, 12-month, randomized controlled trial (RCT) will be conducted within a nationwide Swedish collaboration for diabetes research in primary health care. Individuals with T2DM (n = 142) and mainly sedentary work will be recruited across primary health care centres in five regions in Sweden. Participants will be randomized (1:1) into two groups. A mHealth intervention group who will receive an activity tracker wristband (Garmin Vivofit4), regular SMS text message reminders, and counselling with a diabetes specialist nurse, or a comparator group who will receive counselling with a diabetes specialist nurse only. The primary outcomes are device-measured total sitting time and total number of steps (activPAL3). The secondary outcomes are fatigue, health-related quality of life and musculoskeletal problems (self-reported questionnaires), number of sick leave days (diaries), diabetes medications (clinical record review) and cardiometabolic biomarkers including waist circumference, mean blood pressure, HbA1c, HDL-cholesterol and triglycerides.Discussion: Successful interventions to increase physical activity among those with T2DM have been costly and long-term effectiveness remains uncertain. The use of mHealth technologies such as activity trackers and SMS text reminders may increase awareness of prolonged sedentary behaviour and encourage increase in regular physical activity. mHealth may, therefore, provide a valuable and novel tool to improve health outcomes and clinical management in those with T2DM. This 12-month RCT will evaluate longer-term effects of a mHealth intervention suitable for real-world primary health care settings.
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- Jansson, Stefan P. O., 1959-, et al.
(författare)
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Prevalence and incidence of diabetes mellitus: a nationwide population-based pharmaco-epidemiological study in Sweden
- 2015
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Ingår i: Diabetic Medicine. - : WILEY-BLACKWELL. - 0742-3071 .- 1464-5491. ; 32:10, s. 1319-1328
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Tidskriftsartikel (refereegranskat)abstract
- Aim To investigate the changes in prevalence and incidence of pharmacologically and non-pharmacologically treated diabetes in Sweden during 2005 to 2013. Methods We obtained data on gender, date of birth and pharmacologically and non-pharmacologically treated diabetes from national registers for all Swedish residents. Results During the study period a total of 240 871 new cases of pharmacologically treated diabetes was found. The age-standardized incidence during the follow-up was 4.34 and 3.16 per 1000 individuals in men and women, respectively. A decreasing time trend in incidence for men of 0.6% per year (0.994, 95% CI 0.989-0.999) and for women of 0.7% per year (0.993, 95% CI 0.986-0.999) was observed. The age-standardized prevalence increased from 41.9 and 29.9 per 1000 in 2005/2006 to 50.8 and 34.6 in 2012/2013 in men and women, respectively. This corresponds to an annually increasing time trend for both men (1.024, 95% CI 1.022-1.027) and women (1.019, 95% CI 1.016-1.021). The total age-standardized prevalence of pharmacologically and non-pharmacologically treated diabetes (2012) was 46.9 per 1000 (55.6 for men and 38.8 for women). This corresponds to an annually increasing time trend (2010-2012) for both men (1.017, 95% CI 1.013-1.021) and women (1.012, 95% CI 1.008-1.016). Conclusions The prevalence of pharmacologically treated diabetes increased moderately during 8 years of follow-up, while the incidence decreased modestly. This is in contrast to the results reported by most other studies. The total prevalence of diabetes (both pharmacologically and non-pharmacologically treated) in Sweden is relatively low, from a global viewpoint.
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- Sundström, Johan, Professor, 1971-, et al.
(författare)
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A registry-based randomised trial comparing an SGLT2 inhibitor and metformin as standard treatment of early stage type 2 diabetes (SMARTEST): Rationale, design and protocol
- 2021
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Ingår i: Journal of Diabetes and Its Complications. - : Elsevier BV. - 1056-8727 .- 1873-460X. ; 35:10
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Tidskriftsartikel (refereegranskat)abstract
- Aim: SGLT2 inhibitors have been shown to reduce cardiovascular and renal complications in type 2 diabetes (T2D) patients at high cardiovascular risk. Metformin is currently widely used as initial monotherapy in T2D but lacks convincing data to show that it reduces risk of complications. We aim to compare the SGLT2 inhibitor dapagliflozin and metformin as first-line T2D medication with regard to development of complications in a registry-based randomised controlled trial. Methods: The SGLT2 inhibitor or metformin as standard treatment of early stage type 2 diabetes (SMARTEST) trial will enrol 4300 subjects at 30-40 study sites in Sweden who will be randomised 1:1 to either metformin or dapagliflozin. Participants must have T2D duration <4 years, no prior cardiovascular disease, and be either drug-naive or on monotherapy for T2D. Results: The primary endpoint is a composite of all-cause death, major adverse cardiovascular events and occurrence or progression of microvascular complications (retinopathy, nephropathy, diabetic foot lesions). Secondary endpoints include individual components of the primary endpoint, start of insulin therapy, risk factor biomarkers, patient-reported outcome measures, and cost-effectiveness analysis. Outcomes will primarily be assessed using nationwide healthcare registries. Conclusions: The SMARTEST trial will investigate whether dapagliflozin is superior to metformin in preventing complications in early stage T2D. (Clinicaltrials.gov identifier NCT03982381, EudraCT 2019-001046-17).
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| 6. |
- Cos, X., et al.
(författare)
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Impact on guidelines : the general practitioner point of view
- 2020
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Ingår i: Diabetes Research and Clinical Practice. - : Elsevier. - 0168-8227 .- 1872-8227. ; 166
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Tidskriftsartikel (refereegranskat)abstract
- Primary care physicians are uniquely placed to offer holistic, patient-centred care to patients with T2DM. While the recent FDA-mandated cardiovascular outcome trials offer a wealth of data to inform treatment discussions, they have also contributed to increasing complexity in treatment decisions, and in the guidelines that seek to assist in making these decisions. To assist physicians in avoiding treatment inertia, Primary Care Diabetes Europe has formulated a position statement that summarises our current understanding of the available T2DM treatment options in various patient populations. New data from recent outcomes trials is contextualised and summarised for the primary care physician. This consensus paper also proposes a unique and simple tool to stratify patients into 'very high' and 'high' cardiovascular risk categories and outlines treatment recommendations for patients with atherosclerotic cardiovascular disease, heart failure and chronic kidney disease. Special consideration is given to elderly/frail patients and those with obesity. A visual patient assessment tool is provided, and a comprehensive set of prescribing tips is presented for all available classes of glucose-lowering therapies. This position statement will complement the already available, often specialist-focused, T2DM treatment guidelines and provide greater direction in how the wealth of outcome trial data can be applied to everyday practice.
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| 8. |
- Eriksson, J., et al.
(författare)
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Metformin or SGLT2 inhibitor as 1st line treatment of type 2 diabetes? Design and interim results of the SMARTEST trial
- 2023
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Ingår i: Diabetes Research and Clinical Practice. - : Elsevier. - 0168-8227 .- 1872-8227. ; 197:Supl. 1
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- Background: Metformin is generally recommended as 1 st line medication in T2D. However, there is no compelling evidence of its superiority in preventing diabetes complications. SGLT2 inhibitors prevent cardiovascular mortality, heart failure and renal impairment in T2D patients at high cardiovascular risk.Aim: To assess whether an SGLT2 inhibitor is superior to metformin in preventing organ complications and premature death in early-stage T2D.Method: The SMARTEST study (SGLT2 inhibitor or Metformin As standaRd Treatment of Early Stage Type 2 diabetes) is a registry-based trial in primary care. Participants are included via on-site or video visits at 31 centers across Sweden; T2D <4 yr; drugnaïve (currently 31%) or montherapy; no cardiorenal diseases. Randomizaton 1:1, open label metformin (individualized dose) or dapagliflozin 10 mg/day. Diet, exercise and other medications are stipulated according to national guidelines. Patients are followed 2–6 yrs.Endpoints are collected using NDR and the national Patient Registry. The study will close when 844 primary endpoint events have occurred, giving 90% power to detect a HR of 0.8 for dapagliflozin vs metformin. Primary composite endpoint: time to death, myocardial infarction, stroke, heart failure or appearance/progression of microvascular complications (retinopathy, nephropathy, diabetic foot lesions). Other endpoints include: need for insulin therapy; blood pressure, BMI, HbA1c, PROM and health economy.Results: From late 2019 until May 2022 1100 patients are included. 38% are females, mean age is 60 years and HbA1c 46.5 mmol/mol (6.4%). So far, the primary endpoint event rate is 11/100 patient years (PY), whereas 7/100 PY was estimated from previous data. Nephropathy and foot-at-risk had high rates (6 and 3/100 PY) but MACE was rare (1/100 PY). The recruitment target is 2700 participants, expected by end 2023.Conclusion: Final results are expected in 2025 and can challenge or, equally important, reinforce the current metformin paradigm in early T2D. Event rates are higher than previously recognized for nephropathy and diabetic foot problems but lower for MACE.
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| 10. |
- Fadl, Helena, 1965-, et al.
(författare)
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Changing diagnostic criteria for gestational diabetes in Sweden-a stepped wedge national cluster randomised controlled trial-the CDC4G study protocol
- 2019
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Ingår i: Bmc Pregnancy and Childbirth. - : Springer Science and Business Media LLC. - 1471-2393. ; 19:1
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Tidskriftsartikel (refereegranskat)abstract
- Background The optimal criteria to diagnose gestational diabetes mellitus (GDM) remain contested. The Swedish National Board of Health introduced the 2013 WHO criteria in 2015 as a recommendation for initiation of treatment for hyperglycaemia during pregnancy. With variation in GDM screening and diagnostic practice across the country, it was agreed that the shift to new guidelines should be in a scientific and structured way. The aim of the Changing Diagnostic Criteria for Gestational Diabetes (CDC4G) in Sweden () is to evaluate the clinical and health economic impacts of changing diagnostic criteria for GDM in Sweden and to create a prospective cohort to compare the many long-term outcomes in mother and baby under the old and new diagnostic approaches. Methods This is a stepped wedge cluster randomised controlled trial, comparing pregnancy outcomes before and after the switch in GDM criteria across 11 centres in a randomised manner. The trial includes all pregnant women screened for GDM across the participating centres during January-December 2018, approximately two thirds of all pregnancies in Sweden in a year. Women with pre-existing diabetes will be excluded. Data will be collected through the national Swedish Pregnancy register and for follow up studies other health registers will be included. Discussion The stepped wedge RCT was chosen to be the best study design for evaluating the shift from old to new diagnostic criteria of GDM in Sweden. The national quality registers provide data on the whole pregnant population and gives a possibility for follow up studies of both mother and child. The health economic analysis from the study will give a solid evidence base for future changes in order to improve immediate pregnancy, as well as long term, outcomes for mother and child.
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