-
1.
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
-
-
Free full text
-
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.
-
2.
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.
-
3.
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.
-
4.
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.
-
5.
Increased choroidal thickness: a new indicator for monitoring diabetic macular oedema recurrence.
Mathis, T, Mendes, M, Dot, C, Bouteleux, V, Machkour-Bentaleb, Z, El Chehab, H, Agard, E, Denis, P, Kodjikian, L
Acta ophthalmologica. 2020;(8):e968-e974
-
-
Free full text
-
Abstract
PURPOSE The aim of this study was to determine whether choroidal thickness (CT) increases at the time of exudative recurrence in diabetic patients with unilateral diabetic macular oedema (DME) treated with intravitreal injections of anti-VEGF or dexamethasone. METHODS A real-life, prospective, two-centre study was conducted over a 9-month period investigating diabetic patients presenting with unilateral DME treated with anti-VEGF or dexamethasone intravitreal injections, and CT was measured manually, using the enhanced depth imaging module of the spectral domain optical coherence tomography. Choroidal thickness (CT) was measured in the morning, in both the affected and healthy eye of each patient at two timepoints: when the macula was 'dry' (T0) and at the time of exudative recurrence (T1). RESULTS A total of 51 patients with unilateral DME were included. Mean CT in the affected eye was significantly thicker at the time of exudative recurrence (210.8 ± 44.1 μm at T0 versus 238.0 ± 49.0 μm at T1, p < 0.001). There was no significant variation in CT in the fellow eye (214.4 ± 52.3 µm at T0 versus 218.9 ± 53.4 µm at T1, p = 0.53). The type of intravitreal injection, the number of injections and the CT at T0 had no influence on the change in CT. CONCLUSION This study found that CT increased significantly in the affected eye at the time of recurrence of DME treated with anti-VEGF or dexamethasone injections. Choroidal thickness (CT) could constitute an interesting new indicator for monitoring patients with DME.
-
6.
Use of a Digital Monitoring Platform to Improve Outcomes in Infants With a Single Ventricle.
Vergales, J, Peregoy, L, Zalewski, J, Plummer, ST
World journal for pediatric & congenital heart surgery. 2020;(6):753-759
Abstract
BACKGROUND Despite advances, infants with single ventricle heart disease continue to have high morbidity and mortality in the first year of life. Home monitoring programs (HMPs) have reduced mortality and have grown to use integrative digital platforms. The objective was to evaluate how implementation of a digital HMP platform affects nutritional outcomes in infants undergoing staged single ventricle palliation. METHODS We conducted a retrospective, multicenter, observational study of all infants who required a neonatal operation as part of staged single ventricle palliation between 2013 and 2018. Patients were excluded if less than 35 weeks' gestation or underwent biventricular repair in the first year of life. Implementation of a digital monitoring platform that allows for secure monitoring of nasogastric feed advancement and oxygen saturation occurred in 2016, creating the two groups in a similar surgical era. RESULTS There were 38 patients who fell under a standard HMP compared to 31 utilizing the digital platform. There was no difference in baseline demographics, anatomy, or preoperative factors between the groups. Use of a digital platform was associated with reduced postoperative length of stay (30.1 vs 33.1 days, P = .04). More children in the digital platform monitoring group were able to achieve oral feeding at one year of age (90% vs 68%, P = .03). A total of 25% of infants went home with a nasogastric tube, all but one transitioning to full oral feeds. CONCLUSIONS Use of a digital, fully electronic medical record (EMR)-integrated, comprehensive HMP was associated with shorter postoperative length of stay in neonates undergoing staged single ventricle palliation and allowed for higher rates of full oral feeding.
-
7.
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
-
-
Free full text
-
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.
-
8.
A real-world cohort study on the quality of potassium and creatinine monitoring during initiation of mineralocorticoid receptor antagonists in patients with heart failure.
Nilsson, E, De Deco, P, Trevisan, M, Bellocco, R, Lindholm, B, Lund, LH, Coresh, J, Carrero, JJ
European heart journal. Quality of care & clinical outcomes. 2018;(4):267-273
-
-
Free full text
-
Abstract
AIMS: Clinical heart failure (HF) guidelines recommend monitoring of creatinine and potassium throughout the initial weeks of mineralocorticoid receptor antagonists (MRAs) therapy. We here assessed the extent to which this occurs in our health care. METHODS AND RESULTS Observational study in 2007-2010 HF patients starting MRA therapy in Stockholm, Sweden. Outcomes included potassium and creatinine laboratory testing before MRA initiation and in the early (Days 1-10) and extended (Days 11-90) post-initiation periods. Exclusion criteria considered death/hospitalization within 90 days, and lack of a second MRA dispense. Of 4036 HF patients starting on MRA, 45% were initiated from a hospital, 24% from a primary care centre, and 30% from other private centres. Overall, 89% underwent pre-initiation testing, being more common among hospital (97%) than for primary care (74%) initiations. Only 24% were adequately monitored in all three recommended intervals, being again more frequent following hospital (33%) than private (21%) or primary care (17%) initiations. In multivariable analyses, adequate monitoring was more likely for hospital [odds ratio (OR) 2.85, 95% confidence interval (95% CI) 2.34-3.56] initiations, and for patients with chronic kidney disease (OR 1.79, 95% CI 1.30-2.43) and concomitant use of angiotensin-converting enzyme (OR 1.27, 95% CI 1.05-1.52), angiotensin receptor blockers (OR 1.19, 95% CI 1.01-1.40) or beta-blockers (OR 1.65, 95% CI 1.22-2.26). Age, sex, and prescribing centre explained a small portion of adequate monitoring (c-statistic 0.63). Addition of comorbidities and medications improved prediction marginally (c-statistic 0.65). CONCLUSION Although serum potassium and creatinine monitoring before MRA initiation for HF is frequent, rates of post-initiation monitoring remain suboptimal, especially among primary care centres.
-
9.
Obesity and Overweight Problems Among Individuals 1 to 25 Years Following Acute Rehabilitation for Traumatic Brain Injury: A NIDILRR Traumatic Brain Injury Model Systems Study.
Dreer, LE, Ketchum, JM, Novack, TA, Bogner, J, Felix, ER, Corrigan, JD, Johnson-Greene, D, Hammond, FM
The Journal of head trauma rehabilitation. 2018;(4):246-256
Abstract
OBJECTIVE Examine the prevalence of weight classifications and factors related to obesity/overweight among persons 1 to 25 years following traumatic brain injury (TBI) using the Traumatic Brain Injury Model Systems national database. DESIGN Multicenter, cross-sectional, observational design. SETTING Traumatic Brain Injury Model Systems inpatient rehabilitation facilities. PARTICIPANTS Persons (N = 7287) 1, 2, 5, 10, 15, 20, or 25 years after TBI who required inpatient acute rehabilitation. MAIN OUTCOME MEASURES Body mass index, demographic characteristics, functional, health, satisfaction with life, and global outcomes. RESULTS Overall postinjury weight prevalence rates were 23% obese, 36% overweight, 39% normal, and 3% underweight. Higher rates for obesity and overweight problems were associated with increasing time since injury. Younger (18-19 years) and older (80+ years) age, those in a vegetative state, and those reporting excellent health were less likely to be obese. Individuals with a history of hypertension, heart failure, or diabetes were more likely to be obese. CONCLUSIONS Being obese or overweight presents a health risk in the years following rehabilitation for TBI. The findings support the need for longitudinal studies and highlight the advisability of monitoring weight and promoting healthy lifestyle behaviors over time in survivors of TBI.
-
10.
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.