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

2020 ◽  
Author(s):  
Yu-Zhen Tu ◽  
Ya-Ting Chang ◽  
Hung-Yi Chiou ◽  
Ken Lai
Keyword(s):  
Clinical Practice ◽  
Glycemic Control ◽  
Real World ◽  
Mixed Model ◽  
Diabetes Management ◽  
Mobile App ◽  
Bonferroni Correction ◽  
Retention Group ◽  
Level Of Use ◽  
One Year

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.

Real world benefits of diabetes management app usage and SMBG on glycemic control (Preprint)

2021 ◽  
Author(s):  
Chang Ya Ting ◽  
Yu-Zhen Tu ◽  
Hung-Yi Chiou ◽  
Ken Lai
Keyword(s):  
Blood Glucose ◽  
Glycemic Control ◽  
Real World ◽  
Mixed Model ◽  
Diabetes Management ◽  
Mobile App ◽  
Diabetes Duration ◽  
Percentage Change ◽  
User Group ◽  
Management Platform

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.

scholarly journals A Time-Friendly, Feasible Measure of Nutrition Knowledge in Type 1 Diabetes: The Electronic Nutrition and Carbohydrate Counting Quiz (eNCQ)

2018 ◽  
Vol 13 (1) ◽  
pp. 68-74
Author(s):  
Arwen M. Marker ◽  
Amy E. Noser ◽  
Nicole Knecht ◽  
Mark A. Clements ◽  
Susana R. Patton
Keyword(s):  
Type 1 Diabetes ◽  
Glycemic Control ◽  
Nutrition Education ◽  
Diabetes Management ◽  
Clinical Care ◽  
Nutrition Knowledge ◽  
Diabetes Diagnosis ◽  
Carbohydrate Counting ◽  
One Year

Background: Greater knowledge about nutrition and carbohydrate counting are associated with improved glycemic control and quality of life in youth with type 1 diabetes (T1D). However, limited assessments of nutrition and carbohydrate knowledge have been developed, and existing measures can be time-consuming, overly broad, or not conducive to routine clinical use. To fill this gap, we developed and examined the feasibility of administering the electronic Nutrition and Carbohydrate Counting Quiz (eNCQ). Method: Ninety-two caregivers and 70 youth with T1D (mean age 12.5 years; mean time since diagnosis 5 years; English speaking) completed the 19-item eNCQ via tablet during a routine clinical visit. Completion time and item completion rates were used to assess feasibility. Relationships between eNCQ scores and patient demographics, diabetes management, and health outcomes were examined. Results: Participants took 10 minutes, on average, to complete the eNCQ. Total and Carbohydrate subscale scores (youth report) were negatively correlated with youth hemoglobin A1c (total r = –.38, carbohydrate r = –.38, Ps < .05), indicating that greater nutrition knowledge related to better glycemic control. Nutrition knowledge scores were generally high, but knowledge was negatively related to time since diabetes diagnosis ( r = –.276, P < .05). Conclusions: Findings support feasibility of the eNCQ to assess nutrition knowledge in routine clinical care. Following additional acceptability and validity testing, the eNCQ may identify families in need of further nutrition education. Nutrition assessment is particularly indicated for youth over one year since T1D diagnosis, as these families displayed lower nutrition knowledge and may need continuing education to maintain diabetes-specific nutrition knowledge over time.

scholarly journals Use of a Meter With Color-Range Indicators and a Mobile Diabetes Management App Improved Glycemic Control and Patient Satisfaction in an Underserved Hispanic Population: “Tu Salud”—a Randomized Controlled Partial Cross-Over Clinical Study

2021 ◽  
Author(s):  
Maria Aparicio ◽  
Laurence B. Katz ◽  
Hilary Cameron ◽  
Frederico Ceppa
Keyword(s):  
Glycemic Control ◽  
Treatment Satisfaction ◽  
Diabetes Management ◽  
Mobile App ◽  
Spanish Language ◽  
Control Group ◽  
Hispanic Population ◽  
Diabetes Treatment ◽  
Language Version ◽  
Control Subjects

To demonstrate the clinical value of OneTouch (OT) Verio Flex glucose meter used in combination with a Spanish-language version of the OT Reveal mobile application (app) to support diabetes care and improve glycemic control in an underserved Hispanic population with type 2 diabetes. Test subjects (<i>n </i>= 81) used the meter and app for 12 weeks, while a randomized control group (<i>n </i>= 39) used their own glucose meters without connection to an app. Thereafter, test subjects continued the same regimen for an additional 12 weeks to determine the durability of effect, and control subjects crossed over to use the new meter and app.<b> </b>Test subjects experienced a mean reduction in A1C of 1.0% after 12 weeks (<i>P </i><0.001), a statistically significant greater reduction than in control subjects (<i>P </i>= 0.045). The improvement in A1C in test subjects was sustained over the next 12 weeks. Crossed-over subjects also demonstrated significant improvements in A1C (<i>P </i><0.001). Mean blood glucose was reduced significantly without an increase in hypoglycemia and results in range increased over 12 weeks of meter and mobile app use. Results were independent of subjects’ numeracy skills. Subjects using the new meter and app reacted favorably to the tools and expressed improvements in their diabetes treatment satisfaction based on Diabetes Treatment Satisfaction Questionnaire–Change scores. Use of the OT meter and a Spanish-language version of its diabetes management app in an underserved population helped participants achieve a sustained improvement in glycemic control. The tools were well received by the subjects and may have important utility in other low-numeracy, low-literacy populations. <div><br></div>

scholarly journals Use of a Meter With Color-Range Indicators and a Mobile Diabetes Management App Improved Glycemic Control and Patient Satisfaction in an Underserved Hispanic Population: “Tu Salud”—a Randomized Controlled Partial Cross-Over Clinical Study

2021 ◽  
Author(s):  
Maria Aparicio ◽  
Laurence B. Katz ◽  
Hilary Cameron ◽  
Frederico Ceppa
Keyword(s):  
Glycemic Control ◽  
Treatment Satisfaction ◽  
Diabetes Management ◽  
Mobile App ◽  
Spanish Language ◽  
Control Group ◽  
Hispanic Population ◽  
Diabetes Treatment ◽  
Language Version ◽  
Control Subjects

To demonstrate the clinical value of OneTouch (OT) Verio Flex glucose meter used in combination with a Spanish-language version of the OT Reveal mobile application (app) to support diabetes care and improve glycemic control in an underserved Hispanic population with type 2 diabetes. Test subjects (<i>n </i>= 81) used the meter and app for 12 weeks, while a randomized control group (<i>n </i>= 39) used their own glucose meters without connection to an app. Thereafter, test subjects continued the same regimen for an additional 12 weeks to determine the durability of effect, and control subjects crossed over to use the new meter and app.<b> </b>Test subjects experienced a mean reduction in A1C of 1.0% after 12 weeks (<i>P </i><0.001), a statistically significant greater reduction than in control subjects (<i>P </i>= 0.045). The improvement in A1C in test subjects was sustained over the next 12 weeks. Crossed-over subjects also demonstrated significant improvements in A1C (<i>P </i><0.001). Mean blood glucose was reduced significantly without an increase in hypoglycemia and results in range increased over 12 weeks of meter and mobile app use. Results were independent of subjects’ numeracy skills. Subjects using the new meter and app reacted favorably to the tools and expressed improvements in their diabetes treatment satisfaction based on Diabetes Treatment Satisfaction Questionnaire–Change scores. Use of the OT meter and a Spanish-language version of its diabetes management app in an underserved population helped participants achieve a sustained improvement in glycemic control. The tools were well received by the subjects and may have important utility in other low-numeracy, low-literacy populations. <div><br></div>

scholarly journals Real-world clinical predictors of manic/hypomanic episodes among outpatients with bipolar disorder

PLoS ONE ◽  
2021 ◽  
Vol 16 (12) ◽  
pp. e0262129
Author(s):  
Keita Tokumitsu ◽  
Yasui-Furukori Norio ◽  
Naoto Adachi ◽  
Yukihisa Kubota ◽  
Yoichiro Watanabe ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Substance Abuse ◽  
Clinical Practice ◽  
Personality Disorder ◽  
Real World ◽  
Mood State ◽  
Rapid Cycling ◽  
Bipolar I Disorder ◽  
Antidepressant Prescription ◽  
One Year

Background Bipolar disorder is a mental illness in which manic and depressive states are repeated, causing psychosocial dysfunction. Manic/hypomanic episodes cause problems with interpersonal, social and financial activities, but there is limited evidence regarding the predictors of manic/hypomanic episodes in real-world clinical practice. Methods The multicenter treatment survey on bipolar disorder (MUSUBI) in Japanese psychiatric clinics was administered in an observational study that was conducted to accumulate evidence regarding bipolar disorder in real-world clinical practice. Psychiatrists were asked to complete a questionnaire about patients with bipolar disorder who visited 176 member clinics of the Japanese Association of Neuro-Psychiatric Clinics by conducting a retrospective medical record survey. Our study extracted baseline patient characteristics from September to October 2016, including comorbidities, mental status, duration of treatment, Global Assessment of Functioning (GAF) score, and pharmacological treatment details. We investigated the presence or absence of manic/hypomanic episodes over the course of one year from baseline to September-October 2017. Results In total, 2231 participants were included in our study, 29.1% of whom had manic/hypomanic episodes over the course of one year from baseline. Binomial logistic regression analysis revealed that the presence of manic/hypomanic episodes was correlated with lower baseline GAF scores, rapid cycling, personality disorder, bipolar I disorder, and a mood state with manic or mixed features. Substance abuse was also a risk factor for manic episodes. There was no significant association between a baseline antidepressant prescription and manic/hypomanic episodes. Conclusions In Japan, 29.1% of outpatients with bipolar disorder had manic/hypomanic episodes over the course of one year. Our study suggested that a low GAF score, rapid cycling, personality disorder, bipolar I disorder, substance abuse, and baseline mood state could be predictors of manic/hypomanic episodes. Based on our findings, an antidepressant prescription is not a predictor of manic/hypomanic episodes.

One-Year Safety and Effectiveness of Insulin Degludec in Patients with Diabetes Mellitus in Routine Clinical Practice in India—TRUST (Tresiba Real-World Use Study)

Diabetes ◽  
2018 ◽  
Vol 67 (Supplement 1) ◽  
pp. 1019-P ◽  
Author(s):  
JOTHYDEV KESAVADEV ◽  
L. SREENIVASA MURTHY ◽  
BANSHI D. SABOO ◽  
SADASIVA RAO YALAMANCHI ◽  
BALAMURUGAN RAMANATHAN ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Clinical Practice ◽  
Real World ◽  
Routine Clinical Practice ◽  
Insulin Degludec ◽  
Patients With Diabetes ◽  
One Year

976-P: Evaluation of Hybrid Closed-Loop Insulin Delivery System for Patients with Type 1 Diabetes in Real-World Clinical Practice: A One-Year Qualitative Observational Study

Diabetes ◽  
2020 ◽  
Vol 69 (Supplement 1) ◽  
pp. 976-P
Author(s):  
AHMED H. ELDIB ◽  
SHAHEEN TOMAH ◽  
SHILTON E. DHAVER ◽  
HANNAH GARDNER ◽  
MHD WAEL TASABEHJI ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Clinical Practice ◽  
Observational Study ◽  
Delivery System ◽  
Real World ◽  
Closed Loop ◽  
Insulin Delivery ◽  
Insulin Delivery System ◽  
One Year

scholarly journals Effectiveness and safety of 12-month certolizumab pegol treatment for axial spondyloarthritis in real-world clinical practice in Europe

Rheumatology ◽  
2020 ◽  
Vol 60 (1) ◽  
pp. 113-124
Author(s):  
Xenofon Baraliakos ◽  
Torsten Witte ◽  
Luc De Clerck ◽  
Bruno Frediani ◽  
Eduardo Collantes-Estévez ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Adverse Events ◽  
Real World ◽  
Randomized Clinical Trials ◽  
Axial Spondyloarthritis ◽  
Certolizumab Pegol ◽  
Signs And Symptoms ◽  
Serious Adverse Events ◽  
The Mean ◽  
One Year

Abstract Objectives The efficacy and safety of certolizumab pegol (CZP), an Fc-free, PEGylated anti-TNF, in axial spondyloarthritis (axSpA) has been established in clinical trial settings. We report CZP effectiveness and safety in European clinical practice in patients with axSpA, including radiographic (r-) and non-radiographic (nr-) axSpA. Methods CIMAX (NCT02354105), a European non-interventional multicentre prospective study, observed CZP treatment response and safety over 12 months in a real-world axSpA cohort. The primary outcome was change from baseline in BASDAI to week 52, with additional outcomes pertaining to effectiveness and safety. Patients who received ≥1 dose CZP were followed up for adverse events, and those with baseline and ≥1 post-baseline BASDAI assessment were included in effectiveness analyses. Results A total of 672 patients (r-axSpA: 469; nr-axSpA: 201; unconfirmed diagnosis: 2) from 101 sites received ≥1 dose of CZP, of whom 564 (r-axSpA: 384; nr-axSpA: 179; unconfirmed: 1) were included in the effectiveness analyses. The mean baseline BASDAI was 6.1 in the overall axSpA population and r-axSpA and nr-axSpA subpopulations. At week 52, the mean (s.d.) change in BASDAI was −2.9 (2.3; n = 439); for r-axSpA and nr-axSpA, it was −2.9 (2.2; n = 301) and −2.8 (2.4; n = 137), respectively (P &lt;0.0001 for all). Similar improvements were seen across other axSpA disease measures. In total, 37.9% (255/672) patients experienced adverse events, and 1.8% (12/672) experienced ≥1 serious adverse events. Conclusion Improvements observed in signs and symptoms of axSpA following one year of CZP treatment in real-world clinical practice were similar to those from previous randomized clinical trials, with no new safety concerns.

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