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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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Relationship Between Time in Range, Glycemic Variability, HbA1c, and Complications in Adults With Type 1 Diabetes Mellitus.
El Malahi, A, Van Elsen, M, Charleer, S, Dirinck, E, Ledeganck, K, Keymeulen, B, Crenier, L, Radermecker, R, Taes, Y, Vercammen, C, et al
The Journal of clinical endocrinology and metabolism. 2022;(2):e570-e581
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Abstract
PURPOSE Real-time continuous glucose monitoring (RT-CGM) provides information on glycemic variability (GV), time in range (TIR), and guidance to avoid hypoglycemia, thereby complimenting HbA1c for diabetes management. We investigated whether GV and TIR were independently associated with chronic and acute diabetes complications. METHODS Between September 2014 and January 2017, 515 subjects with type 1 diabetes using sensor-augmented pump therapy were followed for 24 months. The link between baseline HbA1c and CGM-derived glucometrics (TIR [70-180 mg/dL], coefficient of variation [CV], and SD) obtained from the first 2 weeks of RT-CGM use and the presence of complications was investigated. Complications were defined as: composite microvascular complications (presence of neuropathy, retinopathy, or nephropathy), macrovascular complications, and hospitalization for hypoglycemia and/or ketoacidosis. RESULTS Individuals with microvascular complications were older (P < 0.001), had a longer diabetes duration (P < 0.001), a higher HbA1c (7.8 ± 0.9 vs 7.5 ± 0.9%, P < 0.001), and spent less time in range (60.4 ± 12.2 vs 63.9 ± 13.8%, P = 0.022) compared with those without microvascular complication. Diabetes duration (odds ratio [OR] = 1.12 [1.09-1.15], P < 0.001) and TIR (OR = 0.97 [0.95-0.99], P = 0.005) were independent risk factors for composite microvascular complications, whereas SD and CV were not. Age (OR = 1.08 [1.03-1.14], P = 0.003) and HbA1c (OR = 1.80 [1.02-3.14], P = 0.044) were risk factors for macrovascular complications. TIR (OR = 0.97 [0.95-0.99], P = 0.021) was the only independent risk factor for hospitalizations for hypoglycemia or ketoacidosis. CONCLUSIONS Lower TIR was associated with the presence of composite microvascular complications and with hospitalization for hypoglycemia or ketoacidosis. TIR, SD, and CV were not associated with macrovascular complications.
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The effects of professional continuous glucose monitoring as an adjuvant educational tool for improving glycemic control in patients with type 2 diabetes.
Rivera-Ávila, DA, Esquivel-Lu, AI, Salazar-Lozano, CR, Jones, K, Doubova, SV
BMC endocrine disorders. 2021;(1):79
Abstract
BACKGROUND The study objective was to evaluate the effects of professional continuous glucose monitoring (CGM) as an adjuvant educational tool for improving glycemic control in patients with type 2 diabetes (T2D). METHODS We conducted a three-month quasi-experimental study with an intervention (IGr) and control group (CGr) and ex-ante and ex-post evaluations in one family medicine clinic in Mexico City. Participants were T2D patients with HbA1c > 8% attending a comprehensive diabetes care program. In addition to the program, the IGr wore a professional CGM sensor (iPro™2) during the first 7 days of the study. Following this period, IGr participants had a medical consultation for the CGM results and treatment adjustments. Additionally, they received an educational session and personalized diet plan from a dietitian. After 3 months, the IGr again wore the CGM sensor for 1 week. The primary outcome variable was HbA1c level measured at baseline and 3 months after the CGM intervention. We analyzed the effect of the intervention on HbA1c levels by estimating the differences-in-differences treatment effect (Diff-in-Diff). Additionally, baseline and three-month CGM and dietary information were recorded for the IGr and analyzed using the Student's paired t-test and mixed-effects generalized linear models to control for patients' baseline characteristics. RESULTS Overall, 302 T2D patients participated in the study (IGr, n = 150; control, n = 152). At the end of the three-month follow-up, we observed 0.439 mean HbA1C difference between groups (p = 0.004), with an additional decrease in HbA1c levels in the IGr compared with the CGr (Diff-in-Diff HbA1c mean of - 0.481% points, p = 0.023). Moreover, compared with the baseline, the three-month CGM patterns showed a significant increase in the percentage of time in glucose range (+ 7.25; p = 0.011); a reduction in the percentage of time above 180 mg/dl (- 6.01; p = 0.045), a decrease in glycemic variability (- 3.94, p = 0.034); and improvements in dietary patterns, shown by a reduction in total caloric intake (- 197.66 Kcal/day; p = 0.0001). CONCLUSION Professional CGM contributes to reducing HbA1c levels and is an adjuvant educational tool that can improve glycemic control in patients with T2D. TRIAL REGISTRATION ClinicalTrials.gov: NCT04667728 . Registered 16/12/2020.
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A Smart Mobile Application to Monitor Visual Function in Diabetic Retinopathy and Age-Related Macular Degeneration: The CLEAR Study.
Khurana, RN, Hoang, C, Khanani, AM, Steklov, N, Singerman, LJ
American journal of ophthalmology. 2021;:222-230
Abstract
PURPOSE The purpose of this study was to determine if a mobile application, the Checkup Vision Assessment System, could reliably monitor visual acuity (VA) and metamorphopsia remotely versus standard VA reference tests in the clinic. With the current COVID-19 pandemic, an even greater need for remote monitoring exists. Mobile tools enhance the ability to monitor patients virtually by enabling remote monitoring of VA and Amsler grid findings. DESIGN Prospective, multicenter reliability analysis. METHODS Participants: Patients (N = 108) with near corrected VA better than 20/200 and a diagnosis of age-related macular degeneration, diabetic retinopathy, or healthy patients without retinal disease (best-corrected visual acuity [BCVA] of 20/32 or better). INTERVENTION participants were tested using the Checkup, reference VA, and Amsler tests, with the order of testing (Checkup or reference) randomized. Patients monitored their vision using Checkup at least twice a week at home between office visits. Main outcome measurements were near corrected VA and Amsler grid test results. RESULTS Agreement was strong between Checkup and reference tests for VA (r = 0.86) and Amsler grid (sensitivity: 93%; specificity: 92%). Home versus clinic testing showed excellent agreement (r = 0.96). Patients reported successful home use. There were no serious adverse events or discontinuations. Patients rated the usability of Checkup to be excellent. CONCLUSIONS There was good agreement between Checkup and in-clinic test results for VA and Amsler grid. The low variance of Checkup testing, agreement between in-clinic and home results, and excellent usability support Checkup as a reliable method for monitoring retinal pathology in clinic and home settings.
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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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Patterns and Characteristics of a Clinical Implementation of a Self-Monitoring Program for Retina Diseases during the COVID-19 Pandemic.
Teo, KYC, Bachmann, LM, Sim, D, Lee, SY, Tan, A, Wong, TY, Cheung, CMG, Wei Tan, GS
Ophthalmology. Retina. 2021;(12):1245-1253
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PURPOSE We describe the large-scale self-initiated recruitment of patients to a self-monitoring initiative for macular pathologic features during the coronavirus disease 2019 (COVID-19) pandemic. DESIGN Observational study with retrospective analysis. PARTICIPANTS A total of 2272 patients from the Singapore National Eye Centre (SNEC) whose visits were rescheduled over lockdown (April 13-June 1, 2020) were offered participation in a self-monitoring initiative administered by SNEC with the Alleye application (Switzerland) as the testing instrument. METHODS This was an observational study with retrospective analysis. Demographics and characteristics were compared between those who signed up and those who did not. Similar comparisons were made between patients who complied with the initiative versus those who did not. Outcomes were tracked for 6 months starting from the commencement of lockdown. MAIN OUTCOME MEASURES Participation and compliance rates and characteristics of patients who were more likely to participate and comply with the initiative. RESULTS Seven hundred thirty-two patients (32%) participated in this self-monitoring initiative. Those who participated were younger (62 years of age vs. 68 years of age; P < 0.001), men, and living with family. Patients not receiving treatment and those with poorer vision in the worse-seeing eye were more likely to participate. When grouped according to diagnosis, the proportion who participated was highest for diabetic macular edema (52%), nonneovascular age-related macular degeneration (AMD; 42%), diabetic retinopathy (35%), retinal vein occlusions (18%), and neovascular AMD (15%; P < 0.001). Testing compliance rate was 43% (315/732). Patients who complied with the initiative were older, were receiving treatment, and had poorer vision in the worse-seeing eye. Trigger events occurred in 33 patients, with 5 patients having clinically verified disease progression (1.6%). CONCLUSIONS We provide clinical data on characteristics of patients with stable retinal diseases who were offered, participated in, and complied with a self-monitoring program. The lower participation rate compared with standardized clinical studies reflects the difficulties in implementation for such initiatives in clinical settings. Despite this, self-monitoring continues to show promise in relieving clinic resources, suggesting the feasibility of scaling such programs beyond the COVID-19 pandemic.
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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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Perioperative glucose management: Current status and future directions.
Vogt, AP, Bally, L
Best practice & research. Clinical anaesthesiology. 2020;(2):213-224
Abstract
Hyperglycemia in surgical patients is common and associated with increased morbidity and mortality. Optimal perioperative care includes pre-surgery evaluation of glucose control, adequate preoperative management of glucose-lowering therapies, and repeated blood glucose monitoring on the day of surgery. There is consensus regarding the maintenance of intraoperative glucose levels below 10.0 mM through the use of subcutaneous or intravenous insulin, and over the avoidance of aggressive strategies in order to minimize the risk of hypoglycemia. As staffing levels are stretched and prevalence and complexity of cases increase, novel diabetes technologies such as continuous glucose monitoring, insulin pumps and closed-loop glucose control systems can potentially address unmet needs in the provision of perioperative diabetes care. This potential calls for well-designed clinical trials covering various aspects of perioperative glucose management in order to establish evidence-based and standardized practices. This long-term goal relies heavily on communication and collaboration in multidisciplinary teams that include anesthesiologists, surgeons, and endocrinologists.
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Electricity use is associated with residents' vital data and lifestyles: observational study using an IT health support system in Japan.
Yasukawa, K, Ishihara, Y, Hirayama, F, Nakanishi, M, Utsumi, H, Koyama, S
Scientific reports. 2020;(1):17162
Abstract
Motivated by developments in information technology, recording personal parameters with health devices is effective in health promotion. Today's indoor individual lifestyles often involve using electrical appliances. We developed a health support system combined with wireless electricity monitoring and investigated whether electricity use is associated with residents' vital data and lifestyles. We recruited 116 participants in February 2013. Their vital and electricity use data were collected daily. They completed a self-administered questionnaire. Among participants living alone, electricity from 20 February to 11 March 2013 was negatively associated with high-density lipoprotein (HDL) (P = 0.008) and positively associated with low-density lipoprotein (LDL) (P = 0.007) and neutral fat (P = 0.020) levels. Among all participants, electricity use was negatively associated with vegetable intake (P = 0.044) and step count (P = 0.040). Temperature sensitivity in winter was negatively associated with the LDL/HDL ratio for both men and women. For men, temperature sensitivity in winter was negatively related with alcohol intake; for women, it was positively related to body fat percentage and abdominal circumference and negatively correlated to vegetable intake. Temperature sensitivity in summer was positively associated with vegetable intake for men and women. In conclusion, electricity use was related to vital data and lifestyles and influenced by temperature.
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Abdominal compartment syndrome monitoring in neonates with an acute abdomen - A pilot, retrospective, observational study.
Hort, A, Popat, H, Halliday, R, Galea, C, Soundappan, S
Journal of pediatric surgery. 2020;(7):1296-1301
Abstract
BACKGROUND Abdominal compartment syndrome (ACS) is a pathological increase of the intra-abdominal pressure (IAP) with dysfunction of one or more organs. There is lack of clarity in neonates regarding what intravesical pressure (IVP) value, a surrogate marker for IAP, indicates the need for intervention for ACS. METHODS The medical records at a Children's Hospital NICU were reviewed to identify all neonates that had IVP/s monitored over a 10-year period (2008-2017). Demographic parameters, IVPs, and important clinical outcomes were obtained. Associations between IVP monitoring and clinical outcomes were explored. RESULTS Forty-six neonates had IVP monitoring, with 4 (8%) being diagnosed with ACS requiring further operative intervention. There was no significant correlation between IVP and need for surgery. There was a significant positive correlation between the maximum IVP and the need for total parenteral nutrition (rs = 0.350, p = 0.017), ventilator support (rs = 0.321, p = 0.034) and length of stay (rs = 0.362, p = 0.016) and between a diagnosis of ACS and neonatal mortality (rs = 0.299, p = 0.044). CONCLUSIONS IVP monitoring and raised IVP did not correlate with the need for surgical intervention. Raised IVP was associated with neonatal morbidity and maybe neonatal mortality. A large, prospective, observational study is required to evaluate the role of IVP monitoring in ACS and its associated outcomes. LEVEL OF EVIDENCE III.