Effect of Mobile Phone Text Messaging Self-Management Support for Patients With Diabetes or Coronary Heart Disease in a Chronic Disease Management Program (SupportMe) on Blood Pressure: Pragmatic Randomized Controlled Trial.

BACKGROUND: Maintaining engagement and support for patients with chronic diseases is challenging. SMS text messaging programs have complemented patient care in a variety of situations. However, such programs have not been widely translated into routine care. OBJECTIVE: We aimed to examine the implementation and utility of a customized SMS text message-based support program for patients with type 2 diabetes (T2D), coronary heart disease, or both within a chronic disease integrated care program. METHODS: We conducted a 6-month pragmatic parallel-group, single-blind randomized controlled trial that recruited people with T2D or coronary heart disease. Intervention participants received 4 semipersonalized SMS text messages per week providing self-management support to supplement standard care. Preprogrammed algorithms customized content based on participant characteristics, and the messages were sent at random times of the day and in random order by a fully automated SMS text messaging engine. Control participants received standard care and only administrative SMS text messages. The primary outcome was systolic blood pressure. Evaluations were conducted face to face whenever possible by researchers blinded to randomization. Participants with T2D were evaluated for glycated hemoglobin level. Participant-reported experience measures were evaluated using questionnaires and focus groups and summarized using proportions and thematic analysis. RESULTS: A total of 902 participants were randomized (n=448, 49.7% to the intervention group and n=454, 50.3% to the control group). Primary outcome data were available for 89.5% (807/902) of the participants. At 6 months, there was no difference in systolic blood pressure between the intervention and control arms (adjusted mean difference=0.9 mm Hg, 95% CI -1.1 to 2.1; P=.38). Of 642 participants with T2D, there was no difference in glycated hemoglobin (adjusted mean difference=0.1%, 95% CI -0.1% to 0.3%; P=.35). Self-reported medication adherence was better in the intervention group (relative risk=0.82, 95% CI 0.68-1.00; P=.045). Participants reported that the SMS text messages were useful (298/344, 86.6%) and easily understood (336/344, 97.7%) and motivated change (217/344, 63.1%). The lack of bidirectional messaging was identified as a barrier. CONCLUSIONS: The intervention did not improve blood pressure in this cohort, possibly because of high clinician commitment to improved routine patient care as part of the chronic disease management program as well as favorable baseline metrics. There was high program engagement, acceptability, and perceived value. Feasibility as part of an integrated care program was demonstrated. SMS text messaging programs may supplement chronic disease management and support self-care. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12616001689460; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371769&isReview=true. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2018-025923.

Sodium-glucose cotransporter-2 inhibitors improve liver enzymes in patients with co-existing non-alcoholic fatty liver disease: a systematic review and meta-analysis.

Introduction: Non-alcoholic fatty liver disease (NAFLD) is characterized by hepatic steatosis, inflammation, and fibrosis. While sodium-glucose cotransporter-2 (SGLT-2) inhibitors have been established to improve glycaemic control in type-2 diabetes mellitus (T2DM), evidence of the beneficial effects in diabetics with coexisting NAFLD has yet to be quantitatively summarized. Material and methods: We searched the PubMed, Medline, CINAHL, and Cochrane databases and ClinicalTrial.gov from database inception to July 2020. We included randomized controlled trials assessing the impact of SGLT2 inhibitors on liver enzymes among patients with NAFLD. Our primary outcome included liver inflammation as measured using liver transaminase. Secondary outcomes included drug efficacy on hepatic steatosis and body mass index. Risk differences were calculated using a random model. Results: A total of 10,555 patients were included in this meta-analysis (SGLT2 inhibitor group: n = 7125; control group: n = 3430). The treatment duration ranged from 8 to 52 weeks. Patients with T2DM, who were treated with SGLT2 inhibitor had decrease in ALT (SMD = -0.22, 95% CI: -0.27 to -0.20) and AST levels (SMD = -0.20, 95% CI: -0.31 to -0.08). The SGLT-2 inhibitor did not cause statistically significant weight loss (SMD = -0.21, 95% CI: -0.47 to 0.06), fibrosis regression utilizing FIB-4 score (SMD = -0.12, 95% CI: -0.41 to 0.18), and hepatic steatosis by using MRI-PDFF (SMD = -0.31, 95% CI: -0.68 to 0.07), as compared to controls. Conclusions: The SGLT2 inhibitor treatment may improve liver function, as demonstrated in the statistically significant reduction in transaminase levels. There were also notable trends in improved liver fibrosis and steatosis across the study periods.

Aspirin for the prevention of pre-eclampsia in women with pre-existing diabetes: Systematic review.

BACKGROUND: There is a lack of evidence for pre-eclampsia prophylaxis with aspirin in women with pre-existing diabetes mellitus (DM). AIMS: To examine the evidence for aspirin in pre-eclampsia prophylaxis in women with pre-existing DM. MATERIAL AND METHODS: An electronic search using Ovid MEDLINE, Embase, CinicalTrials.gov and the Cochrane CENTRAL register of controlled trials through to February 2021 was performed. Reference lists of identified studies, previous review articles, clinical practice guidelines and government reports were manually searched. Randomised controlled trials (RCTs) of aspirin vs placebo for pre-eclampsia prophylaxis were included. Articles were manually reviewed to determine if cohorts included women with DM. The systematic review was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Data from included trials were extracted independently by two authors who also independently assessed risk of bias as per the Cochrane Handbook criteria version 5.1.0. Data were analysed using Rev-Man 5.4. RESULTS: Forty RCTs were identified, of which 11 included a confirmed subset of women with DM; however, data were insufficient for meta-analysis. Meta-analysis of 930 women with DM, from individual patient data included in a systematic review and unpublished data from one of the 11 RCTs, showed a non-significant difference in the outcome of pre-eclampsia in participants treated with aspirin compared to placebo (odds ratio 0.58; 95% CI 0.20-1.71; P = 0.33). CONCLUSIONS: Pre-eclampsia risk reduction with aspirin prophylaxis in women with pre-existing DM may be similar to women without pre-existing DM. However, randomised data within this meta-analysis were insufficient, warranting the need for further studies within this high-risk group of women.

Insights into the management of anorectal disease in the coronavirus 2019 disease era.

Coronavirus 2019 disease (COVID-19) has created major impacts on public health. The virus has plagued a large population requiring hospitalization and resource utilization. Knowledge about the COVID-19 virus continues to grow. It can commonly present with gastrointestinal symptoms; initially, this was considered an atypical presentation, which led to delays in care. The pandemic has posed serious threats to the care of anorectal diseases. Urgent surgeries have been delayed, and the care of cancer patients and cancer screenings disrupted. This had added to patient discomfort and the adverse outcomes on healthcare will continue into the future. The better availability of personal protective equipment to providers and standard checklist protocols in operating rooms can help minimize healthcare-related spread of the virus. Telehealth, outpatient procedures, and biochemical tumor marker tests can help with mitigation of anorectal-disease-related problems. There is limited literature about the clinical management of anorectal diseases during the pandemic. We performed a detailed literature review to guide clinicians around management options for anorectal disease patients. We also highlighted the health challenges seen during the pandemic.

Text messaging support for patients with diabetes or coronary artery disease (SupportMe): protocol for a pragmatic randomised controlled trial.

INTRODUCTION: Low-cost interventions providing self-management support are needed for people with coronary artery disease (CAD) and diabetes. Mobile phone text messaging provides a potential vehicle for this. The SupportMe Trial aims to assess the feasibility of embedding a text messaging programme into routine clinical practice and will determine if this improves cardiovascular risk factor and diabetes control among patients with CAD or type 2 diabetes. METHODS AND ANALYSIS: SupportMe is a randomised controlled trial to be conducted within the framework of a health district-wide integrated care programme for people with CAD or type 2 diabetes mellitus. One thousand subjects will be recruited, with at least 500 in each group. Intervention subjects will receive four text messages a week for 6 months, which provide advice, motivation, information and support for disease management and healthy behaviour. The primary outcome is systolic blood pressure at 6 months. Secondary outcomes include body mass index, waist circumference, low-density lipoprotein cholesterol, physical activity levels, dietary intake, quality of life, mood and smoking cessation, and for subjects with diabetes, glycosylated haemoglobin and fasting serum glucose. A process and economic evaluation will also be conducted. ETHICS AND DISSEMINATION: The study has been approved by the Western Sydney Local Health District Human Research Ethics Committee (AU RED HREC/16/WMEAD/331). Results will be disseminated via the scientific forums including peer-reviewed publications and presentations at national and international conferences. TRIAL REGISTRATION NUMBER: ACTRN12616001689460.

Mobile phone text messaging in improving glycaemic control for patients with type 2 diabetes mellitus: A systematic review and meta-analysis.

BACKGROUND: Mobile health is the use of mobile technology in developing healthcare, with the aim of reminding and motivating patients to adopt a healthy lifestyle. We conducted a systematic review assessing the effectiveness of text-messaging interventions on HbA1c in patients with Type 2 diabetes mellitus (T2DM). METHODS: Two authors independently searched MEDLINE, Embase, CINAHL, Cochrane Register of Randomized Control Trials and PsychInfo. The review included randomized control trials with at least 4 weeks follow up, evaluating the effect of text messaging on HbA1c, in patients with T2DM. Trials involving participants with Type 1 diabetes mellitus, pre-diabetes or gestational diabetes, or other forms of telemedicine were excluded. Studies employing bi-directional messaging were excluded. RESULTS: 208 papers were identified as meeting inclusion criteria and their abstracts reviewed. Of these, we examined the full text article of forty-four studies. Eleven randomized controlled trials were included in the final review, with a total of 1710 participants. One study focused on medication adherence only, while the remaining had educational and motivational messages. Five studies showed a significant improvement in HbA1c with the intervention. The remaining studies demonstrated a trend to improvement in HbA1c. Our meta-analysis on 9 of the 11 studies found an overall reduction in HbA1c of 0.38% (-0.53; -0.23, p-value <0.001). CONCLUSION: Lifestyle-focused text messaging is a low cost initiative aimed at motivating patients with T2DM to adhere to a healthy lifestyle. We demonstrate that lifestyle focused text messaging is effective, with a significant improvement in HbA1c in the meta-analysis.