scholarly journals The Effects of Continuous Usage of Diabetes Management App on Glycemic Control in Real-world Clinical Practice: Retrospective Analysis (Preprint)

Author(s):  
Yu-Zhen Tu ◽  
Ya-Ting Chang ◽  
Hung-Yi Chiou ◽  
Ken Lai
2020 ◽  
Author(s):  
Yu-Zhen Tu ◽  
Ya-Ting Chang ◽  
Hung-Yi Chiou ◽  
Ken Lai

BACKGROUND The efficacy of digital technology in improving diabetes management has typically been demonstrated through studies based on randomized controlled trials (RCTs), showing steeper decrease of hemoglobin A1c (HbA1c) values for patients who adopted a digital solution. However, evidence from real-world clinical practice is still limited. OBJECTIVE To evaluate the effectiveness of digital interventions by tracking HbA1c improvement over one year in real-world clinical settings. METHODS The Health2Sync mobile app was used by patients to track self-measured outcomes and communicate with health care professionals (HCPs). The web-based Patient Management Platform was used by HCPs to monitor patient data, view test results from clinical labs, and communicate with patients. Patients that have been onboarded for at least 13 months and had consecutive HbA1c results for five quarters were included in the analysis. They were then stratified into three groups (high, mid, and low retention) according to their level of use of the mobile app in the first six months after onboarding. A mixed model was built to compare the slopes of HbA1c percentage decreases between the groups. In addition, these patients’ stickiness on the app from the seventh to the twelfth month was verified with multiple comparisons. RESULTS A sample of 2036 users was included in the analysis. With the mixed model coefficient estimates, we found that app users had significant HbA1c percentage decreases as the passed quarter count increased (t = -9.869, P < .001), and that effectiveness was enlarged in high and mid retention groups as the interaction effects were significantly negative compared with the low retention group (t = -6.620, P < .001 for passed quarter count * mid retention; t = -5.173, P < .001 for passed quarter count * high retention). The low retention group also had the highest average HbA1c value in the end of the 13 months [mean (SD): 7.01 (1.02) %, 6.99 (1.00) %, and 7.17 (1.14) % for high, mid, and low retention groups, respectively, P = .07, .02, and 1.00 for high-low, mid-low, and high-mid difference comparison after Bonferroni correction]. The level of use of the app remained consistent in the seventh to the twelfth month after onboarding [mean (SD): 5.23 (1.37) months, 2.43 (1.68) months, and 0.41 (0.97) months for high, mid, and low retention groups, respectively, P < .001 for all comparison pairs after Bonferroni correction]. CONCLUSIONS Our analysis showed that continuous usage of the diabetes management app is associated with better glycemic control in real-world clinical practice. Further studies can be performed to reveal the efficacy for specific diabetes types and to observe the effects beyond one year.


2021 ◽  
Vol 12 ◽  
Author(s):  
Mary C. Mahony ◽  
Brooke Hayward ◽  
Gilbert L. Mottla ◽  
Kevin S. Richter ◽  
Stephanie Beall ◽  
...  

PurposeTo determine the pattern of dose adjustment of recombinant human follicle-stimulating hormone alfa (r-hFSH-alfa) during ovarian stimulation (OS) for assisted reproductive technology (ART) in a real-world setting.MethodsThis was an observational, retrospective analysis of data from an electronic de-identified medical records database including 39 clinics in the USA. Women undergoing OS for ART (initiated 2009–2016) with r-hFSH-alfa (Gonal-f® or Gonal-f RFF Redi-ject®) were included. Assessed outcomes were patients’ baseline characteristics and dosing characteristics/cycle.ResultsOf 33,962 ART cycles, 13,823 (40.7%) underwent dose adjustments: 23.4% with ≥1 dose increase, 25.4% with ≥1 dose decrease, and 8.1% with ≥1 increase and ≥1 decrease. Patients who received dose adjustments were younger (mean [SD] age 34.8 [4.58] years versus 35.9 [4.60] years, p&lt;0.0001) and had lower BMI (25.1 [5.45] kg/m2 versus 25.5 [5.45] kg/m2, p&lt;0.0001) than those who received a constant dose. The proportion of patients with non-normal ovarian reserve was 38.4% for those receiving dose adjustment versus 51.9% for those with a constant dose. The mean (SD) number of dose changes/cycle was 1.61 (0.92) for cycles with any dose adjustment, 1.72 (1.03) for cycles with ≥1 dose increase, 2.77 (1.00) for cycles with ≥1 dose increase and ≥1 decrease (n=2,755), and 1.88 (1.03) for cycles with ≥1 dose decrease.ConclusionsDose adjustment during OS is common in clinical practice in the USA and occurred more often in younger versus older patients, those with a high versus non-normal ovarian reserve or those with ovulation disorders/polycystic ovary syndrome versus other primary diagnoses of infertility.


2020 ◽  
Vol 54 (1) ◽  
pp. 119-127 ◽  
Author(s):  
Nezka Hribernik ◽  
Marko Boc ◽  
Janja Ocvirk ◽  
Jasna Knez-Arbeiter ◽  
Tanja Mesti ◽  
...  

AbstractBackgroundBased on recent data from clinical trials, the immune checkpoint inhibitor pembrolizumab prolongs survival and has a good toxicity profile in patients with advanced or metastatic melanoma. However, the question remains whether these results are transmitted into daily clinical practice. The aim of this study was to assess the efficacy and toxicity of pembrolizumab in treatment-naive patients with metastatic melanoma in everyday clinical practice in Slovenia and compare it to the results from clinical trials.Patients and methodsThis observational retrospective cohort study included 138 consecutive metastatic treatment-naive melanoma patients treated with pembrolizumab at the Institute of Oncology Ljubljana in Slovenia, from January 2016 to December 2018. Patient and treatment characteristics were retrospectively collected from hospital data base. Statistical data was obtained using the SPSS software version 22. Survival rate was calculated with the Kaplan-Meier method. Observation period took place between January 2016 and the end of June 2019.ResultsThe estimated median overall survival (OS) was 25.1 months (95% CI, 14.6–35.6) and the median progression-free survival (PFS) was 10.7 months (95% CI, 5.9–15.4). Among all patients, 29 (21.0%) achieved complete response, 31 (22.5%) partial response and 23 (16.7%) reached stable disease. The number of organs with metastatic involvement and the level of baseline lactate dehydrogenase (LDH) concentration had significant influence on survival rates. Immune-related adverse events (irAE) were reported in 88 (63%) patients, while grade 3–4 irAE occurred in 12 (8.7%). Due to toxicity, 16 (11.6%) patients discontinued the treatment.ConclusionsOur real-world data from single centre retrospective analysis of treatment-naive metastatic melanoma patients treated with pembrolizumab showed inferior median OS and similar median PFS, compared to the results from clinical trials. However, patients with normal serum levels of LDH and a small number of organs with metastatic involvement had comparable survival outcomes. Toxicity rates of pembrolizumab were quite similar. These results further support the use of pembrolizumab for metastatic treatment-naive melanoma patients.


2021 ◽  
Author(s):  
Chang Ya Ting ◽  
Yu-Zhen Tu ◽  
Hung-Yi Chiou ◽  
Ken Lai

BACKGROUND Among the self-care measures, self-monitoring of blood glucose (SMBG) is a critical component for checking blood glucose levels. However, for non-insulin-treated DMT2 patients, the value of SMBG was inconsistent among studies. In addition, there is growing evidence suggesting that digital technologies are being adopted as an additional method for healthcare systems to increase patient contact. However, evidence from real-world clinical practice is still limited. OBJECTIVE To assess non-insulin-treated DMT2 patients that were receiving care from the same clinic and analyze whether usage of a diabetes management app and SMBG behavior affect glycemic control in real-world clinical settings. METHODS We collaborated with a large clinic in Taiwan focused on diabetes care that has been using the Health2Sync mobile app and web-based Patient Management Platform to collect the data. The patients were divided into two groups (app-engaged-user, only-data-uploader) according to different activities in the app, and blood glucose was recorded every month from 1 to 6 months after registration in the app. A sample of 420 patients was included in the analysis, and a linear mixed model was built to investigate what factors affect patients' blood glucose percentage change. RESULTS With the mixed model coefficient estimates, we found that the percentage change was significantly negative when the only-data-uploader group was set as the baseline (t = -4.289, P < .001 for the patients of app-engaged-user group).Furthermore, we found that for patients with shorter diabetes duration the blood glucose decreased more ( t = 4.219, P < .001 for the number of diabetes duration). Finally, we also found that the count of blood glucose measured enlarged the decrease along the interaction months (t = -6.911, P < .001 for Nth month * count of blood glucose in Nth month). CONCLUSIONS Our analysis showed that the blood glucose percentage change of the patient who was in the app-engaged-user group dropped more than that of the patient who was in the only-data-uploader group, shorter diabetes duration is associated with steeper decrease in the patient's blood glucose percentage change, and the more frequently patients test SMBG each month, the higher the decrease in the patient's blood glucose percentage. Further studies can be performed to consider the differences in daily behaviors such as exercise, diet across the patients, and these factors could have vital impacts on glycemic control.


2012 ◽  
Vol 18 (5) ◽  
pp. 660-667 ◽  
Author(s):  
Cheryl Rosenfeld ◽  
Nancy Bohannon ◽  
Bruce Bode ◽  
Adam Kelman ◽  
Shari Mintz ◽  
...  

Sign in / Sign up

Export Citation Format

Share Document