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Personal Activity Intelligence e-Health Program in People with Type 2 Diabetes: A Pilot Randomized Controlled Trial.
Coombes, JS, Keating, SE, Mielke, GI, Fassett, RG, Coombes, BK, O'Leary, KP, Cox, ER, Burton, NW
Medicine and science in sports and exercise. 2022;(1):18-27
Abstract
INTRODUCTION Innovative strategies are needed to enable people with type 2 diabetes (T2D) to self-manage physical activity (PA). Personal Activity Intelligence (PAI) is a new metric that uses the heart rate response to PA to inform the user as to whether they are doing enough PA to reduce the risk of premature mortality. The PAI score reflects PA over the previous 7 d with the goal to maintain a score ≥100. The aim of this study was to investigate the feasibility, acceptability, and efficacy of the PAI e-Health Program in people with T2D. METHODS Thirty participants with T2D who were not meeting PA guidelines were randomly assigned to 12 wk of either 1) PAI e-Health Program or 2) PA attention control. The PAI e-Health Program consisted of receiving a wrist-worn heart rate monitor and an app with the PAI metric, and attending 4 × 2 h·wk-1 sessions of exercise and counseling. Feasibility and acceptability of the program were evaluated by achievement of a PAI score ≥100 and participant feedback. Efficacy was determined from changes in glycemic control, cardiorespiratory fitness, exercise capacity (time-on-test), body composition, sleep time, and health-related quality of life. RESULTS Program participants in the PAI e-Health Program had a mean ± SD PAI score of 119.7 ± 60.6 and achieved ≥100 PAI on 56.4% of the days. The majority of participants (80%) intended to continue to use PAI monitoring. Compared with control, the PAI group significantly improved their exercise capacity (mean difference, 95% confidence interval) (63 s, 17.9-108.0 s), sleep time (67.2 min, 7.2-127.1 min), total percent body fat (-1.3%, -2.6% to -0.1%), and gynoid fat percent (-1.5%, -2.6 to -0.5). CONCLUSIONS The PAI e-Health Program is feasible, acceptable, and efficacious in people with T2D.
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Systematic monitoring for detection of atrial fibrillation in patients with acute ischaemic stroke (MonDAFIS): a randomised, open-label, multicentre study.
Haeusler, KG, Kirchhof, P, Kunze, C, Tütüncü, S, Fiessler, C, Malsch, C, Olma, MC, Jawad-Ul-Qamar, M, Krämer, M, Wachter, R, et al
The Lancet. Neurology. 2021;(6):426-436
Abstract
BACKGROUND Systematic electrocardiogram (ECG) monitoring improves detection of covert atrial fibrillation in stroke survivors but the effect on secondary prevention is unknown. We aimed to assess the effect of systematic ECG monitoring of patients in hospital on the rate of oral anticoagulant use after 12 months. METHODS In this investigator-initiated, randomised, open-label, parallel-group multicentre study with masked endpoint adjudication, we recruited patients aged at least 18 years with acute ischaemic stroke or transient ischaemic attack without known atrial fibrillation in 38 certified stroke units in Germany. Patients were randomly assigned (1:1) to usual diagnostic procedures for atrial fibrillation detection (control group) or additional Holter-ECG recording for up to 7 days in hospital (intervention group). Patients were stratified by centre using a random permuted block design. The primary outcome was the proportion of patients on oral anticoagulants at 12 months after the index event in the intention-to-treat population. Secondary outcomes included the number of patients with newly diagnosed atrial fibrillation in hospital and the composite of recurrent stroke, major bleeding, myocardial infarction, or death after 6 months, 12 months, and 24 months. This trial was registered with ClinicalTrials.gov, NCT02204267, and is completed and closed for participants. FINDINGS Between Dec 9, 2014, and Sept 11, 2017, 3465 patients were randomly assigned, 1735 (50·1%) to the intervention group and 1730 (49·9%) to the control group. Oral anticoagulation status was available in 2920 (84·3%) patients at 12 months (1484 [50·8%] in the intervention group and 1436 [49·2%] in the control group). For the primary outcome, at 12 months, 203 (13·7%) of 1484 patients in the intervention group versus 169 (11·8%) of 1436 in the control group were on oral anticoagulants (odds ratio [OR] 1·2 [95% CI 0·9-1·5]; p=0·13). Atrial fibrillation was newly detected in patients in hospital in 97 (5·8%) of 1714 in the intervention group versus 68 (4·0%) of 1717 in the control group (hazard ratio [HR] 1·4 [95% CI 1·0-2·0]; p=0·024). The composite of cardiovascular outcomes and death did not differ between patients randomly assigned to the intervention group versus the control group at 24 months (232 [13·5%] of 1714 vs 249 [14·5%] of 1717; HR 0·9 [0·8-1·1]; p=0·43). Skin reactions due to study ECG electrodes were reported in 56 (3·3%) patients in the intervention group. All-cause death occured in 73 (4·3%) patients in the intervention group and in 103 (6·0%) patients in the control group (OR 0·7 [0·5-0·9]). INTERPRETATION Systematic core centrally reviewed ECG monitoring is feasible and increases the detection rate of atrial fibrillation in unselected patients hospitalised with acute ischaemic stroke or transient ischaemic attack, if added to usual diagnostic care in certified German stroke units. However, we found no effect of systematic ECG monitoring on the rate of oral anticoagulant use after 12 months and further efforts are needed to improve secondary stroke prevention. FUNDING Bayer Vital. TRANSLATION For the German translation of the abstract see Supplementary Materials section.
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A pragmatic and scalable strategy using mobile technology to promote sustained lifestyle changes to prevent type 2 diabetes in India and the UK: a randomised controlled trial.
Nanditha, A, Thomson, H, Susairaj, P, Srivanichakorn, W, Oliver, N, Godsland, IF, Majeed, A, Darzi, A, Satheesh, K, Simon, M, et al
Diabetologia. 2020;(3):486-496
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Abstract
AIMS/HYPOTHESIS This randomised controlled trial was performed in India and the UK in people with prediabetes to study whether mobile phone short message service (SMS) text messages can be used to motivate and educate people to follow lifestyle modifications, to prevent type 2 diabetes. METHODS The study was performed in people with prediabetes (n = 2062; control: n = 1031; intervention: n = 1031) defined by HbA1c ≥42 and ≤47 mmol/mol (≥6.0% and ≤6.4%). Participants were recruited from public and private sector organisations in India (men and women aged 35-55 years) and by the National Health Service (NHS) Health Checks programme in the UK (aged 40-74 years without pre-existing diabetes, cardiovascular disease or kidney disease). Allocation to the study groups was performed using a computer-generated sequence (1:1) in India and by stratified randomisation in permuted blocks in the UK. Investigators in both countries remained blinded throughout the study period. All participants received advice on a healthy lifestyle at baseline. The intervention group in addition received supportive text messages using mobile phone SMS messages 2-3 times per week. Participants were assessed at baseline and at 6, 12 and 24 months. The primary outcome was conversion to type 2 diabetes and secondary outcomes included anthropometry, biochemistry, dietary and physical activity changes, blood pressure and quality of life. RESULTS At the 2 year follow-up (n = 2062; control: n = 1031; intervention: n = 1031), in the intention-to-treat population the HR for development of type 2 diabetes calculated using a discrete-time proportional hazards model was 0.89 (95% CI 0.74, 1.07; p = 0.22). There were no significant differences in the secondary outcomes. CONCLUSIONS/INTERPRETATION This trial in two countries with varied ethnic and cultural backgrounds showed no significant reduction in the progression to diabetes in 2 years by lifestyle modification using SMS messaging. TRIAL REGISTRATION The primary study was registered on www.ClinicalTrials.gov (India, NCT01570946; UK, NCT01795833). FUNDING The study was funded jointly by the Indian Council for Medical Research and the UK Medical Research Council.
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The effect of BCM guided dry weight assessment on short-term survival in Chinese hemodialysis patients : Primary results of a randomized trial - BOdy COmposition MOnitor (BOCOMO) study.
Liu, L, Sun, Y, Chen, Y, Xu, J, Yuan, P, Shen, Y, Lin, S, Sun, W, Ma, Y, Ren, J, et al
BMC nephrology. 2020;(1):135
Abstract
BACKGROUND Lack of accurate and effective assessment tools of fluid status is one of the major challenges to reach proper dry weight (DW) in chronic hemodialysis (HD) population. The aim of this randomized study was to evaluate the effect of bioimpedance guided DW assessment on long-term outcomes in Chinese HD patients. Eligible patients were randomly assigned (1:1) to two groups in each center, the control group and body composition monitor (BCM) group. In the BCM group, DW has been evaluated by bioimpedance technic every 2 months during follow-up. The primary composite endpoint consisted of death, acute myocardial infarction, cerebral infarction, cerebral hemorrhage, and peripheral vascular disease. METHODS A total of 445 patients were recruited from 11 hemodialysis centers from Beijing, Tianjin and Shijiazhuang cities from Jan 1, 2013 to Dec 31, 2014. They were randomized into either BCM group or control group. All patients have been followed up for 1 year or until Dec 31, 2014 or censoring. RESULTS At baseline, there were no significant differences between two groups in terms of demographic parameters, dialysis vintage, percentage of vascular access, and comorbid conditions. At the end of the study, 18 (4.04%) patients had died (11 in control group and 7 in BCM group). Kaplan-Meier survival analysis showed no significant difference in survival rates between two groups (log-rank test P = 0.07). However, there was an increasing trend of survival rates in BCM group compared to the control group. In the multivariable Cox analysis, there was a nonsignificant trend toward less primary composite end points in the BCM group in the adjusted analysis, the hazard ratio was impressive (0.487, 95% CI 0.217-1.091, P = 0.08). CONCLUSION Bioimpedance technic has been applied to assess fluid status for decades and has been proved to be a promising tool for clinical practice. Although short-term outcomes were not improved in the randomized, controlled trial, the ascending trend in survival has been observed. Further studies are needed to investigate the survival benefit of bioimpedance method in DW assessment in a larger sample with longer follow-up period. TRIAL REGISTRATION ClinicalTrials.org, NCT01509937. Registered 13 January 2012.
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Application of multivariate longitudinal models in SIRT6, FBS, and BMI analysis of the elderly.
Gilani, N, Haghshenas, R, Esmaeili, M
The aging male : the official journal of the International Society for the Study of the Aging Male. 2019;(4):260-265
Abstract
Objective: SIRT6 is a main regulator of metabolism and lifespan and its importance has been implicated in the prevention against aging-related diseases. The objective of this study was to examine the application of multivariate longitudinal models in SIRT6, FBS, and BMI analysis in the elderly men after eight weeks concurrent training with supplementation of l-arginine (l-Arg). Methods: Thirty two elderly men with mean age of 63.09 ± 3.71 years were randomly divided into four equal-sized groups (each n = 8); Exercise + supplement (ES) group; exercise + placebo (EP) group; supplement (S) group and control (C) group. The ES and EP groups performed the eight weeks of concurrent training, three sessions per week. Group ES and group S consumed 1000 mg of l-Arg per day at 8:00 pm. Measurements of biochemical variables were done by ELISA Reader method. For analytical purposes, we used the paired sample t-test and multivariate longitudinal modeling with generalized estimating equation (GEE) methodology. All analyses have been implemented in R-3.4.1. p Values less than .05 were considered statistically significant. Results: With respect to significant association between sirt6, FBS, and BMI, this study showed that synergy effect of training and supplementation was greater than the sum of their individual effects on SIRT6 (β = 0.79, p < .001), FBS (β = -5.56, p = .022), and BMI (β = -3.89; p = .041). Also exercise alone had a significantly larger effect than supplementation alone on responses. Conclusions: It can be concluded that the joint usage of concurrent training and supplement of l-Arg for elderly men could improve the metabolism and body composition.
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Outcomes after multiple courses of granulocyte colony-stimulating factor and growth hormone in decompensated cirrhosis: A randomized trial.
Verma, N, Kaur, A, Sharma, R, Bhalla, A, Sharma, N, De, A, Singh, V
Hepatology (Baltimore, Md.). 2018;(4):1559-1573
Abstract
UNLABELLED Decompensated cirrhosis (DC) carries a high mortality. Liver transplantation (LT) is the treatment of choice; however, the limited availability of donor organs has resulted in high waitlist mortality. The present study investigated the impact of multiple courses of granulocyte-colony stimulating factor (G-CSF) with or without growth hormone (GH) in these patients. Sixty-five patients with DC were randomized to standard medical therapy (SMT) plus G-CSF 3 monthly plus GH daily (group A; n = 23) or SMT plus G-CSF (group B; n = 21) or SMT alone (group C; n = 21). The primary outcome was transplant-free survival (TFS) at 12 months. Secondary outcomes were mobilization of CD34+ cells at day 6 and improvement in clinical scores, liver stiffness, nutrition, episodes of infection, and quality of life (QOL) at 12 months. There was significantly better 12-month TFS in groups A and B than in group C (P = 0.001). At day 6 of therapy, CD34+ cells increased in groups A and B compared to baseline (P < 0.001). There was a significant decrease in clinical scores, improvement in nutrition, better control of ascites, reduction in liver stiffness, lesser infection episodes, and improvement in QOL scores in groups A and B at 12 months as compared to baseline (P < 0.05). The therapies were well tolerated. CONCLUSION Multiple courses of G-CSF improved 12-month TFS, mobilized hematopoietic stem cells, improved disease severity scores, nutrition, fibrosis, QOL scores, ascites control, reduced infections, and the need for LT in patients with DC. However, the use of GH was not found to have any additional benefit. (Hepatology 2017).
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Self-monitoring of urinary salt excretion as a method of salt-reduction education: a parallel, randomized trial involving two groups.
Yasutake, K, Miyoshi, E, Misumi, Y, Kajiyama, T, Fukuda, T, Ishii, T, Moriguchi, R, Murata, Y, Ohe, K, Enjoji, M, et al
Public health nutrition. 2018;(12):2164-2173
Abstract
OBJECTIVE The present study aimed to evaluate salt-reduction education using a self-monitoring urinary salt-excretion device. DESIGN Parallel, randomized trial involving two groups. The following parameters were checked at baseline and endline of the intervention: salt check sheet, eating behaviour questionnaire, 24 h home urine collection, blood pressure before and after urine collection. SETTING The intervention group self-monitored urine salt excretion using a self-measuring device for 4 weeks. In the control group, urine salt excretion was measured, but the individuals were not informed of the result. SUBJECTS Seventy-eight individuals (control group, n 36; intervention group, n 42) collected two 24 h urine samples from a target population of 123 local resident volunteers. The samples were then analysed. RESULTS There were no differences in clinical background or related parameters between the two groups. The 24 h urinary Na:K ratio showed a significant decrease in the intervention group (-1·1) compared with the control group (-0·0; P=0·033). Blood pressure did not change in either group. The results of the salt check sheet did not change in the control group but were significantly lower in the intervention group. The score of the eating behaviour questionnaire did not change in the control group, but the intervention group showed a significant increase in eating behaviour stage. CONCLUSIONS Self-monitoring of urinary salt excretion helps to improve 24 h urinary Na:K, salt check sheet scores and stage of eating behaviour. Thus, usage of self-monitoring tools has an educational potential in salt intake reduction.
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A double-blind, randomised, placebo-controlled, cross-over study assessing the use of XEN-D0103 in patients with paroxysmal atrial fibrillation and implanted pacemakers allowing continuous beat-to-beat monitoring of drug efficacy.
Shunmugam, SR, Sugihara, C, Freemantle, N, Round, P, Furniss, S, Sulke, N
Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing. 2018;(3):191-197
Abstract
PURPOSE The ultrarapid delayed rectifier current (IKur) carried by Kv1.5 channels, which are solely expressed in the atrium, is a potential target for safer treatment of paroxysmal atrial fibrillation (PAF). XEN-D0103 is a nanomolar ion channel blocker that selectively inhibits potassium ion flux through the Kv1.5 ion channel. The efficacy of XEN-D0103 in reducing AF burden was assessed in patients with DDDRp permanent pacemakers (PPMs) and PAF. METHODS A double-blind, placebo-controlled, cross-over study was performed in patients with PAF and DDDRp PPMs with advanced atrial and ventricular Holters allowing beat-to-beat arrhythmia follow-up. All anti-arrhythmic drugs were withdrawn before randomised treatment. After baseline assessment, patients were randomly assigned to two treatment periods of placebo then XEN-D0103 50 mg bd, or XEN-D0103 50 mg bd then placebo. RESULTS Fifty-four patients were screened and 21 patients were eligible and included in the randomised trial. All 21 patients completed both treatment periods. The primary endpoint was change in AF burden assessed by PPM. There was no significant difference in AF burden on treatment with XEN-D0103 versus placebo. There was a reduction in the mean frequency of AF episodes (relative reduction 0.72, 95% CI 0.66 to 0.77; p < 0.0001). XEN-D0103 was safe and well tolerated, and there were no serious adverse events. XEN-D0103 did not have any apparent effect on heart rate compared to placebo. CONCLUSIONS XEN-D0103 did not reduce AF burden in patients with PAF and dual chamber pacemakers providing beat-to-beat monitoring. XEN-D0103 was well tolerated and did not have any apparent effect on heart rate. Although single-ion channel blockade with XEN-D0103 did not affect AF in this study, there might be a potential for this agent to be used in combination with other atrially specific drugs in the treatment of AF. EUDRACT TRIAL REGISTRATION NUMBER 2013-004456-38.
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Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial.
Feig, DS, Donovan, LE, Corcoy, R, Murphy, KE, Amiel, SA, Hunt, KF, Asztalos, E, Barrett, JFR, Sanchez, JJ, de Leiva, A, et al
Lancet (London, England). 2017;(10110):2347-2359
Abstract
BACKGROUND Pregnant women with type 1 diabetes are a high-risk population who are recommended to strive for optimal glucose control, but neonatal outcomes attributed to maternal hyperglycaemia remain suboptimal. Our aim was to examine the effectiveness of continuous glucose monitoring (CGM) on maternal glucose control and obstetric and neonatal health outcomes. METHODS In this multicentre, open-label, randomised controlled trial, we recruited women aged 18-40 years with type 1 diabetes for a minimum of 12 months who were receiving intensive insulin therapy. Participants were pregnant (≤13 weeks and 6 days' gestation) or planning pregnancy from 31 hospitals in Canada, England, Scotland, Spain, Italy, Ireland, and the USA. We ran two trials in parallel for pregnant participants and for participants planning pregnancy. In both trials, participants were randomly assigned to either CGM in addition to capillary glucose monitoring or capillary glucose monitoring alone. Randomisation was stratified by insulin delivery (pump or injections) and baseline glycated haemoglobin (HbA1c). The primary outcome was change in HbA1c from randomisation to 34 weeks' gestation in pregnant women and to 24 weeks or conception in women planning pregnancy, and was assessed in all randomised participants with baseline assessments. Secondary outcomes included obstetric and neonatal health outcomes, assessed with all available data without imputation. This trial is registered with ClinicalTrials.gov, number NCT01788527. FINDINGS Between March 25, 2013, and March 22, 2016, we randomly assigned 325 women (215 pregnant, 110 planning pregnancy) to capillary glucose monitoring with CGM (108 pregnant and 53 planning pregnancy) or without (107 pregnant and 57 planning pregnancy). We found a small difference in HbA1c in pregnant women using CGM (mean difference -0·19%; 95% CI -0·34 to -0·03; p=0·0207). Pregnant CGM users spent more time in target (68% vs 61%; p=0·0034) and less time hyperglycaemic (27% vs 32%; p=0·0279) than did pregnant control participants, with comparable severe hypoglycaemia episodes (18 CGM and 21 control) and time spent hypoglycaemic (3% vs 4%; p=0·10). Neonatal health outcomes were significantly improved, with lower incidence of large for gestational age (odds ratio 0·51, 95% CI 0·28 to 0·90; p=0·0210), fewer neonatal intensive care admissions lasting more than 24 h (0·48; 0·26 to 0·86; p=0·0157), fewer incidences of neonatal hypoglycaemia (0·45; 0·22 to 0·89; p=0·0250), and 1-day shorter length of hospital stay (p=0·0091). We found no apparent benefit of CGM in women planning pregnancy. Adverse events occurred in 51 (48%) of CGM participants and 43 (40%) of control participants in the pregnancy trial, and in 12 (27%) of CGM participants and 21 (37%) of control participants in the planning pregnancy trial. Serious adverse events occurred in 13 (6%) participants in the pregnancy trial (eight [7%] CGM, five [5%] control) and in three (3%) participants in the planning pregnancy trial (two [4%] CGM and one [2%] control). The most common adverse events were skin reactions occurring in 49 (48%) of 103 CGM participants and eight (8%) of 104 control participants during pregnancy and in 23 (44%) of 52 CGM participants and five (9%) of 57 control participants in the planning pregnancy trial. The most common serious adverse events were gastrointestinal (nausea and vomiting in four participants during pregnancy and three participants planning pregnancy). INTERPRETATION Use of CGM during pregnancy in patients with type 1 diabetes is associated with improved neonatal outcomes, which are likely to be attributed to reduced exposure to maternal hyperglycaemia. CGM should be offered to all pregnant women with type 1 diabetes using intensive insulin therapy. This study is the first to indicate potential for improvements in non-glycaemic health outcomes from CGM use. FUNDING Juvenile Diabetes Research Foundation, Canadian Clinical Trials Network, and National Institute for Health Research.
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Stimulated urine C-peptide creatinine ratio vs serum C-peptide level for monitoring of β-cell function in the first year after diagnosis of Type 1 diabetes.
Tatovic, D, Luzio, S, Dunseath, G, Liu, Y, Alhadj Ali, M, Peakman, M, Dayan, CM, ,
Diabetic medicine : a journal of the British Diabetic Association. 2016;(11):1564-1568
Abstract
AIMS: To determine if urine C-peptide/creatinine ratio is a useful tool for monitoring β-cell function in new-onset Type 1 diabetes. METHODS Data were obtained from a prospective immunomodulation study in people with Type 1 diabetes ≤ 3 months from diagnosis, with a standard mixed-meal tolerance test and measurement of urine C-peptide/creatinine ratio carried out at 0, 3, 6, 9 and 12 months. The change in the insulin-dose-adjusted HbA1c level was also correlated with the change in serum/urine C-peptide level during the 12-month follow-up period. RESULTS A significant reduction in urine C-peptide/creatinine ratio, measured after a mixed-meal, was reached at 9 months (-45.4%), whilst the reduction in stimulated serum C-peptide level reached significance after 3 months (-54.7%) in placebo-treated participants. Neither change in stimulated serum C-peptide nor change in urine C-peptide level correlated with each other, and nor did change in insulin-dose-adjusted HbA1c level in the first 6 months, but all measures correlated significantly in the second half of the 12-month follow-up period. CONCLUSION Mixed-meal-stimulated urine C-peptide/creatinine ratio was similar to, although less sensitive than, stimulated serum C-peptide level in monitoring β-cell function during the first year after diagnosis. Because the former is significantly less invasive, it warrants inclusion in further studies in Type 1 diabetes and may represent an attractive alternative outcome measure in cohort studies and in children.