Role of Mobile Technology to Improve Diabetes Care in Adults with Type 1 Diabetes: The Remote-T1D Study iBGStar® in Type 1 Diabetes Management.
Ontology highlight
ABSTRACT: Introduction
The role of mobile technology in patient-reported outcomes (PRO) and glycemic control in adults with type 1 diabetes (T1D) needs further evaluation.Methods
The single-center, prospective, 6-month, open-label, investigator-initiated study randomized 100 subjects with T1D in a 1:1 fashion to a control group using self-monitoring of blood glucose (SMBG) with Accu-Chek Nano® and an intervention group using SMBG with iPhone plus glucose meter (iBGStar®). The primary endpoint was the change in PRO (hypoglycemia fear score, behavior and worry subscores). Secondary outcomes were the improvement in glycemic variability indices and the reduction in A1c values.Results
Baseline demographics and glycosylated hemoglobin (A1c) values were similar in the two groups. There was a significant decrease in A1c value at 6 months in iBGStar® group compared to the control group (-0.16 vs. -0.51, p = 0.04). The total insulin dose increased significantly in the iBGStar® group at 3 months but did not change at 6 months. The hypoglycemia fear scale (PRO) improved in both groups at 6 months (-1.4 ± 10.0 vs. -3.9 ± 12.5, p = 0.32).Conclusion
The use of iBGStar® resulted in better glycemic control and improvement in some PRO (hypoglycemia fear and behavior scores) compared to the control group at 6 months with no increased risk of hypoglycemia.Clinical trial registration
ClinicalTrials.gov: NCT01825382.Funding
Sanofi.
SUBMITTER: Garg SK
PROVIDER: S-EPMC5544609 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:AimThis study will test the feasibility and effectiveness of mobile technology intervention on the patients' self-management of oral anticancer medication. Secondary objectives include acceptability, the usefulness of text messages, and satisfaction by participants and nurses.MethodsThis prospective two-arm study will recruit patients (N = 220) with metastatic breast cancer and initiating treatment with palbociclib (Ibrance ®). Allowing for attrition, patients will be randomized into the control (N = 100) or intervention (N = 100) group. Unidirectional text message reminders will be sent during the treatment cycle through a secure web application using the patient's smartphone. Self-reported survey responses will be collected at three time points; at consent, end of treatment cycles, and the follow-up clinic visit and include a demographic questionnaire, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Post study questionnaire and the R-15 Patient Satisfaction Questionnaire. Nurses providing care for study patients will complete the Adaptation of Stamps Nurse Workload questionnaire. Data will be analysed an intent-to-treat analysis comparing the two arms. Study approval was obtained in December 2019 and funded in January 2020.DiscussionSmartphones are globally available and have text messaging capability which is increasingly being used as an intervention in healthcare studies. This study will test a low-cost, nurse-led intervention that enhances the patient's experience with oral anti-cancer medications, improves access to care, reduces costs, and improves the satisfaction of nurses caring for oncology patients.ImpactDespite the ease of administering oral anti-cancer medications, oncology patients maynot take them as prescribed and consequently, these factors affect patient outcomes and disease control. Given the importance of taking oral anti-cancer medications and the difficulties patients experience in achieving it, the effective use of mobile technology interventions can actively engage patients in their care and improve medication self-management of anticancer treatment regimens.
| S-EPMC8454747 | biostudies-literature
Project description:IntroductionWe evaluated the efficacy and safety of ultra-rapid lispro (URLi) in comparison to lispro in a subgroup analysis of Japanese adults with type 1 diabetes mellitus from the phase 3 PRONTO-T1D trial.MethodsAfter an 8-week lead-in to optimize basal insulin treatment, patients were randomized to 52-week double-blind mealtime URLi or lispro, or 26-week open-label postmeal URLi. The primary endpoint was change in hemoglobin A1c (HbA1c) from baseline (week 0) to week 26 between mealtime URLi and lispro. The multiplicity adjusted objectives were 1- and 2-h postprandial glucose (PPG) excursions after a meal test between mealtime URLi and lispro, and change in HbA1c from baseline to week 26 between postmeal URLi and mealtime lispro.ResultsThis manuscript presents pre-specified exploratory analyses of 26-week data from Japanese patients randomized to double-blind URLi (n = 62) or lispro (n = 59), or open-label URLi (n = 46). Mean baseline HbA1c levels were 7.52% for mealtime URLi, 7.44% for lispro, and 7.51% for postmeal URLi at randomization. At week 26, the least squares mean (LSM) difference compared to lispro was 0.04% (95% confidence interval [CI] - 0.14 to 0.22) for mealtime URLi, and 0.16% (95% CI - 0.04 to 0.35) for postmeal URLi. In comparison to lispro, mealtime URLi resulted in statistically significantly lower 1- and 2-h PPG excursions during the mixed-meal tolerance test. LSM differences were - 40.5 mg/dL, 95% CI - 59.5 to 21.4 (- 2.25 mmol/L, 95% CI - 3.3 to - 1.2) for 1-h PPG excursions and - 51.7 mg/dL, 95% CI - 81.7 to - 21.8 (- 2.87 mmol/L, 95% CI - 4.5 to - 1.2) for 2-h PPG excursions at week 26. There were no significant treatment differences in rates of severe/overall hypoglycemia, or incidence of treatment-emergent adverse events.ConclusionsMealtime and postmeal URLi provide effective and comparable glycemic control in Japanese patients. Mealtime URLi demonstrated more effective PPG control compared to lispro.Trial registrationClinicalTrials.gov, NCT03214367.
| S-EPMC7435141 | biostudies-literature
Project description:Essential tremor (ET) is the most common movement disorder. Individuals exhibit postural and kinetic tremor that worsens over time and patients may also exhibit other motor and non-motor symptoms. While millions of people are affected by this disorder worldwide, several barriers impede an optimal clinical management of symptoms. In this paper, we discuss the impact of ET on patients and review major issues to the optimal management of ET; from the side-effects and limited efficacy of current medical treatments to the limited number of people who seek treatment for their tremor. Then, we propose seven different areas within which mobile and wearable technology may improve the clinical management of ET and review the current state of research in these areas.
| S-EPMC5916972 | biostudies-other
Project description:BACKGROUND:The increasing use of Web-based solutions for health prevention and promotion presents opportunities to improve self-management and adherence to guideline-based therapy for individuals with type 2 diabetes (T2DM). Despite promising preliminary evidence, many users stop using Web-based solutions due to the burden of data entry, hidden costs, loss of interest, and a lack of comprehensive features. Evaluations tend to focus on effectiveness or impact and fail to evaluate the nuanced variables that may interact to contribute to outcome success (or failure). OBJECTIVE:This study aimed to evaluate a Web-based solution for improving self-management in T2DM to identify key combinations of contextual variables and mechanisms of action that explain for whom the solution worked best and in what circumstances. METHODS:A qualitative realist evaluation was conducted with one-on-one, semistructured telephonic interviews completed at baseline, and again toward the end of the intervention period (3 months). Topics included participants' experiences of using the Web-based solution, barriers and facilitators of self-management, and barriers and facilitators to effective use. Transcripts were analyzed using thematic analysis strategies, after which the key themes were used to develop statements of the relationships between the key contextual factors, mechanisms of action, and impact on the primary outcome (glycated hemoglobin, HbA1c). RESULTS:Twenty-six interviews (14 baseline, 12 follow-up) were completed with 16 participants with T2DM, and the following 3 key groups emerged: the easiest fit, the best fit, and those who failed to activate. Self-efficacy and willingness to engage with the solution facilitated improvement in HbA1c, whereas competing priorities and psychosocial issues created barriers to engagement. Individuals with high baseline self-efficacy who were motivated, took ownership for their actions, and prioritized diabetes management were early and eager adopters of the app and recorded improvements in HbA1c over the intervention period. Individuals with moderate baseline self-efficacy and no competing priorities, who identified gaps in understanding of how their actions influence their health, were slow to adopt use but recorded the greatest improvements in HbA1c. The final group had low baseline self-efficacy and identified a range of psychosocial issues and competing priorities. These participants were uncertain of the benefits of using a Web-based solution to support self-management, ultimately resulting in minimal engagement and no improvement in HbA1c. CONCLUSIONS:Self-efficacy, competing priorities, previous behavior change, and beliefs about Web-based solutions interact to determine engagement and impact on the clinical outcomes. Considering the balance of these patient characteristics is likely to help health care providers identify individuals who are apt to benefit from a Web-based solution to support self-management of T2DM. Web-based solutions could be modified to incorporate the existing screening measures to identify individuals who are at risk of suboptimal adherence to inform the provision of additional support(s) as needed.
| S-EPMC5878364 | biostudies-literature
Project description:ObjectiveTo provide a snapshot of the profile of adults and youth with type 1 diabetes (T1D) in the United States and assessment of longitudinal changes in T1D management and clinical outcomes in the T1D Exchange registry.Research design and methodsData on diabetes management and outcomes from 22,697 registry participants (age 1-93 years) were collected between 2016 and 2018 and compared with data collected in 2010-2012 for 25,529 registry participants.ResultsMean HbA1c in 2016-2018 increased from 65 mmol/mol at the age of 5 years to 78 mmol/mol between ages 15 and 18, with a decrease to 64 mmol/mol by age 28 and 58-63 mmol/mol beyond age 30. The American Diabetes Association (ADA) HbA1c goal of <58 mmol/mol for youth was achieved by only 17% and the goal of <53 mmol/mol for adults by only 21%. Mean HbA1c levels changed little between 2010-2012 and 2016-2018, except in adolescents who had a higher mean HbA1c in 2016-2018. Insulin pump use increased from 57% in 2010-2012 to 63% in 2016-2018. Continuous glucose monitoring (CGM) increased from 7% in 2010-2012 to 30% in 2016-2018, rising >10-fold in children <12 years old. HbA1c levels were lower in CGM users than nonusers. Severe hypoglycemia was most frequent in participants ≥50 years old and diabetic ketoacidosis was most common in adolescents and young adults. Racial differences were evident in use of pumps and CGM and HbA1c levels.ConclusionsData from the T1D Exchange registry demonstrate that only a minority of adults and youth with T1D in the United States achieve ADA goals for HbA1c.
| S-EPMC7061293 | biostudies-literature
Project description:BackgroundThe Nightscout Project is a leading example of patient-designed, do-it-yourself (DIY), open-source technology innovations to support type 1 diabetes management. We are unaware of studies that have described the evolution of patient-driven innovations from the Nightscout Project to date.MethodsWe identified patient-driven, DIY innovations from posts and comments in the "CGM in the Cloud" private Facebook group as well as data from Twitter, GitHub, and the Nightscout website. For each innovation, we described its intent or its unaddressed need as well as the associated features and improvements. We conducted a thematic analysis to identify overarching patterns among the innovations, features, and improvements, and compared the timeline of innovations in the DIY space with the timing of similar innovations in the commercial space.ResultsWe identified and categorized innovations in Nightscout with the most commonly appearing themes of: visualization improvements, equipment improvements, and user experience improvements. Other emerging themes included: Care Portal support, safety, remote monitoring, decision support, international support, artificial pancreas, pushover notifications, and open-source collaboration.ConclusionsThis rapid development of patient-designed DIY innovations driven by unmet needs in the type 1 diabetes community reflects a revolutionary, bottom-up approach to medical innovation. Nightscout users accessed features earlier than if they had waited for commercial products, and they also personalized their tools and devices, empowering them to become the experts of their own care.
| S-EPMC7753857 | biostudies-literature
Project description:BackgroundAlthough short-term blood glucose levels and variability are thought to underlie diminished function and emotional well-being in people with type 1 diabetes (T1D), these relationships are poorly understood. The Function and Emotion in Everyday Life with T1D (FEEL-T1D) study focuses on investigating these short-term dynamic relationships among blood glucose levels, functional ability, and emotional well-being in adults with T1D.ObjectiveThe aim of this study is to present the FEEL-T1D study design, methods, and study progress to date, including adaptations necessitated by the COVID-19 pandemic to implement the study fully remotely.MethodsThe FEEL-T1D study will recruit 200 adults with T1D in the age range of 18-75 years. Data collection includes a comprehensive survey battery, along with 14 days of intensive longitudinal data using blinded continuous glucose monitoring, ecological momentary assessments, ambulatory cognitive tasks, and accelerometers. All study procedures are conducted remotely by mailing the study equipment and by using videoconferencing for study visits.ResultsThe study received institutional review board approval in January 2019 and was funded in April 2019. Data collection began in June 2020 and is projected to end in December 2021. As of June 2021, after 12 months of recruitment, 124 participants have enrolled in the FEEL-T1D study. Approximately 87.6% (7082/8087) of ecological momentary assessment surveys have been completed with minimal missing data, and 82.0% (82/100) of the participants provided concurrent continuous glucose monitoring data, ecological momentary assessment data, and accelerometer data for at least 10 of the 14 days of data collection.ConclusionsThus far, our reconfiguration of the FEEL-T1D protocol to be implemented remotely during the COVID-19 pandemic has been a success. The FEEL-T1D study will elucidate the dynamic relationships among blood glucose levels, emotional well-being, cognitive function, and participation in daily activities. In doing so, it will pave the way for innovative just-in-time interventions and produce actionable insights to facilitate tailoring of diabetes treatments to optimize the function and well-being of individuals with T1D.International registered report identifier (irrid)DERR1-10.2196/30901.
| S-EPMC8544739 | biostudies-literature
Project description:SGLT2i (sodium glucose transporter type 2 inhibitors) are pharmacological agents that act by inhibiting the SGLT2, by reducing the renal plasma glucose threshold and inducing glycosuria, resulting in a blood glucose lowering effect. In recent years, studies demonstrating some additional positive effects of SGLT2i also in the treatment of T1D have increased progressively. The SGLT2i dapagliflozin and sotagliflozin have been temporarily licensed for use by the European Medical Agency (EMA) as an adjunct to insulin therapy in adults with T1D with a body mass index of 27 kg/m2 or higher. However, in the meantime, the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee was divided, citing concerns about the main side effects of SGLT2i, especially diabetic ketoacidosis (DKA). The aim of this manuscript was to conduct an update on current evidence and recommendations of the reported use of SGLT2i in the treatment of T1D in humans. Preclinical studies, clinical trial and real world data suggest benefits in glycaemia control and nefro-cardiovascular protection, even though several studies have documented an important increase in the risk of DKA, a serious and life-threatening adverse event of these agents. SGLT2i potentially addresses some of the unmet needs associated with T1D by improving glycaemic control with weight loss and without increasing hypoglycemia, by reducing glycaemic variability. However, due to side effects, EMA recommendation for SGLT2 use on T1D was withdrawn. Further studies will be needed to determine the safety of this therapy in T1D and to define the type of patient who can benefit most from these medications.
| S-EPMC10642354 | biostudies-literature
Project description:Background Drug closed-loop management reflects the level of hospital management and pharmacist service. It is a challenge for hospital pharmacists to realize the whole-process closed-loop management of drugs in hospital pharmacies. Therefore, this study aimed to evaluate the operational effect of using mobile technology to build a closed-loop drug management system. Methods Using mobile technology, replacing the traditional paper dispensing model and constructing a multinode information collection system according to the Healthcare Information and Management Systems Society Standard, we reformed the hospital information system and inpatient pharmacy workflow and then evaluated the new approach using statistical methods. Results After the transformation, the entire process of drug data can be traced. Closed-loop management, as well as real-time data verification and control, thereby improves the work efficiency and reduces the drug dispensing time. By reducing the work error rate, the number of dispensing errors decreased from 5 to 1 case/month. The comprehensive dispensing process can achieve the whole workflow of paperless operation and reduce the use of paper A4 by 180,000 pieces per year. Conclusions Mobile technology can improve the service level of pharmacies, enhance the level of drug management and hospital quality management, ensure the safety of medication for inpatients, and significantly reduce the amount of paper used. Supplementary Information The online version contains supplementary material available at 10.1186/s12911-022-02067-2.
| S-EPMC9703708 | biostudies-literature
Project description:The use of mobile applications for dietary purposes has dramatically increased along with the consistent development of mobile technology. Assessing diet quality as a dietary pattern or an indicator across key food groups in comparison to those recommended by dietary guidelines is useful for identifying optimal nutrient intake. This systematic review aims to explore mobile applications and their impact on the diet quality of the user. The electronic databases of The Cumulative Index to Nursing and Allied Health Literature (Cinahl), The American Psychological Association's (APA Psycinfo), and PubMed were systematically searched for randomised and non-randomised controlled trials to retrieve papers from inception to November 2021. Ten studies with 1638 participants were included. A total of 5342 studies were retrieved from the database searches, with 10 articles eligible for final inclusion in the review. The sample sizes ranged from 27 to 732 participants across the included studies, with 1638 total participants. The ratio of female to male participants in the studies was 4:1. The majority of the mobile applications or M-health interventions were used to highlight dietary health changes (six studies), with the remainder used to reduce weight or blood sugar levels (four studies). Each study used a different measure to quantify diet quality. Studies were either assessed by diet quality scoring or individual dietary assessment, of the ten studies, six studies reported an improvement in diet quality following diet-related mobile application use. Mobile applications may be an effective way to improve diet quality in adults; however, there is a need for more targeted and longer-term studies that are expressly designed to investigate the impact using mobile applications has on diet quality.
| S-EPMC9230785 | biostudies-literature