BackgroundThe "real" effect size of a medical therapy is constant over time. In contrast, the effect size reported in randomised controlled trials (RCTs) may change over time because the sum of all kinds of bias influencing the reported effectiveness is not necessarily constant. As this would affect the validity of meta-analyses, we tested the hypothesis that the reported effect size decreases over time. Furthermore, we tested three hypotheses that would explain a possible change.MethodsBecause of well established outcome measures, the lipid-lowering drugs Pravastatin and Atorvastatin (serum low-density lipoprotein cholesterol, LDL-C) and the anti-glaucoma drugs Timolol and Latanoprost (intraocular pressure, IOP) were chosen for this investigation. Studies were identified by a standardized MEDLINE search. RCTs investigating the above identified medications administered as monotherapy, and in defined dosages, were included. Publication year, baseline (= pre-treatment value in the treatment group of interest) and post intervention means, number of patients and the assignment to experimental or control group were extracted for each study.ResultsA total of 625 citations were screened; 206 met the inclusion criteria. The reported effect size of Pravastatin (change of reported effect size in five years: -3.22% LDL-C, P < .0001), Timolol (-0.56 mmHg, P < .0001) and Latanoprost (-1.78 mmHg, P = .0074) decreased over time, while there was no significant change for Atorvastatin (+0.31% LDL-C, P = .8618). Multiple regression analysis showed that baseline values were the most important influencing factor; study size or treatment group did not play a significant role.ConclusionThe effectiveness of medical therapies reported in RCTs decreases over time in three of the four investigated pharmaceuticals, caused mainly by baseline differences. We call this phenomenon "fading of reported effectiveness". Under this condition the validity of a meta-analysis may be impaired. Therefore we propose to observe this phenomenon in future meta-analyses in order to guarantee a maximum of transparency.
Digital health management is increasingly pivotal in the care of patients with diabetes. The aim of this review was to evaluate the clinical benefits of using smart insulin pens with connectivity for diabetes management. The search was performed using PubMed and PubMed Central on May 15, 2019, to identify publications investigating the use of insulin pens. Studies evaluating insulin pens with connectivity via Bluetooth/Near Field Communication, with an associated electronic device enabling connectivity, or with a memory function were included in the review. Nine studies were identified in the search. Overall, these studies lacked data on smart insulin pens with a connectivity function, with eight of the available studies investigating only pens with a memory function. The studies focused primarily on assessing patient preference, usability, and technical accuracy. The number of studies assessing clinical outcomes was small ( n = 3). However, the majority of studies ( n = 8) reported that patients preferred smart insulin pens because they increased confidence with regard to diabetes self-management. These results suggest a lack of published data regarding smart insulin pens with connectivity for the management of diabetes. However, the available published data on usability and patient preference suggest that the use of smart insulin pens holds promise for improving and simplifying diabetes self-management.
Background The aim of the study was to assess the safety and glycemic outcomes with the use of a Do-It-Yourself (DIY) Hybrid Closed-Loop (HCL) system based on the AndroidAPS application in type 1 diabetes (T1D). Methods Single-center clinical trial, with 3-week run-in and 12-week study period. DIY HCL system consisted of the Dana Diabecare RS insulin pump, Dexcom G5 continuous glucose monitoring system and AndroidAPS application. Primary outcome was safety: incidences of severe hypoglycemia, diabetic ketoacidosis, time spent in glycemia <54 mg/dl. Secondary endpoints included percentage of time in range (TIR) 70–180 mg/dl, time below 70 mg/dl, HbA1c, insulin requirements, and body weight. Results In total 12 subjects (5 men, 7 women) were enrolled, mean age 31.3±6.7, 95%CI(27.7–34.9) years, mean diabetes duration 16.1±5.7, 95%CI(13.0–19.2) years. No episodes of severe hypoglycemia or ketoacidosis were observed. Percentage of time spent in glycemia below 54mg/dl was not increased. Average sensor glycemia was lower in the study period than baseline (141.1 ± 8.4, 95%CI(136.3–145.9) vs. 153.3 ± 17.9, 95%CI(143.2–163.4), mg/dl p<0.001). TIR 70–180 mg/dl was improved by 11.3%, 95%CI(2.8%-19.8%) (from 68.0 ± 12.7 to 79.3 ± 6.4%, p<0.001), without increasing hypoglycemia time. The HbA1c level decreased by -0.5%, 95%CI(-0.9%–-0.1%) (from 6.8 ± 0.5 to 6.3 ± 0.4%, p<0.001). Additionally, in the last 4 weeks of the study period participants significantly improved and showed TIR 70–180 mg/dl 82.1 ± 5.6%, 95%CI(78.9–85.3), time <54 mg/dl 0.30 (0.20–0.55)%, median 95%CI(0.1–0.7) and <70 mg/dl 1.90 (1.10–3.05)%, median 95%CI(0.7–3.2). The insulin requirement and body weight did not change in the study. Conclusions The study revealed safety of the Do-It-Yourself HCL system AndroidAPS in adults with T1D, limited to well-controlled, highly selected and closely monitored patients. The use of AndroidAPS significantly improved HbA1c, time in range and average sensor glycemia without increasing hypoglycemia. As both patients and their medical team are gaining experience using the system over time, they improve glycemic control. Trial registration German Clinical Trials Register: no. DRKS00015439; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015439.
Continuous glucose monitoring (CGM) represents a significant advance for the treatment of patients with diabetes mellitus. 1 Usage of CGM enables an increased understanding of the effects that various influences of daily life have on changes in glucose levels, for example, diet, insulin, and physical exercise.Providing patients with a CGM system without special training and professional coaching does not usually improve their metabolic status. 2,3 Patients need a wide range of information and skills in order to use the full potential of a CGM system and also to avoid potential negative aspects, for example, overcorrection. At present such training services are mostly given in individual and often unstructured consultations by a physician or (more often) by a certified diabetes educator. These are not ideal conditions for a structured training session. Structured training sessions are not only necessary at the start of CGM usage, but also through the long-term use of CGM if the patients are unable to cope with the system or if the therapy targets are not achieved.The
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