Dataset Information

Impact of My Dose Coach App Frequency of Use on Clinical Outcomes in Type 2 Diabetes.

ABSTRACT:

Introduction

My Dose Coach (MDC) is a US Food and Drug Administration-approved digital smartphone application designed to help users with type 2 diabetes (T2D) titrate their basal insulin (BI) according to a clinician-prescribed individualized titration plan. The aim of this analysis was to assess the impact of the frequency of MDC use on clinical outcomes.

Methods

This retrospective observational analysis included people with T2D who were registered for MDC (August 1st, 2018-April 30th, 2020) and received BI. Users with an activated care plan and ≥2 fasting blood glucose (FBG) observations spanning ≥2 weeks were defined as active. Outcomes included percentage achieving their individual FBG target, time to FBG target, change in FBG, change in insulin dose and hypoglycemia. Users were stratified into high (>3 days per week), moderate (>1- ≤3 days per week), and low (≤1 day per week) MDC usage groups.

Results

The analysis included 2517 active MDC users. Approximately 49% of users had high MDC usage. Overall, 44% of users across all usage frequencies achieved their individual FBG target. High MDC use was associated with significantly better FBG target achievement and less time to FBG target versus moderate- and low-usage groups (p≤0.01 for all). Insulin dose change was significantly greater in the high- versus moderate-usage group (p=0.01). There was no significant difference in hypoglycemia incidence among MDC usage groups (12%-16% of users in any usage group).

Conclusions

More frequent MDC usage was associated with better FBG outcomes without increased hypoglycemia risk.

SUBMITTER: Unnikrishnan AG

PROVIDER: S-EPMC8938735 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

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Publications

Impact of My Dose Coach App Frequency of Use on Clinical Outcomes in Type 2 Diabetes.

Unnikrishnan Ambika Gopalakrishnan AG Viswanathan Vijay V Zhou Fang Liz FL Hao Lichen L Kamath Prithvi P Bertolini Monica M Botero Jose Fernando JF Mancillas-Adame Leonardo L

Diabetes therapy : research, treatment and education of diabetes and related disorders 20220322 5

<h4>Introduction</h4>My Dose Coach (MDC) is a US Food and Drug Administration-approved digital smartphone application designed to help users with type 2 diabetes (T2D) titrate their basal insulin (BI) according to a clinician-prescribed individualized titration plan. The aim of this analysis was to assess the impact of the frequency of MDC use on clinical outcomes.<h4>Methods</h4>This retrospective observational analysis included people with T2D who were registered for MDC (August 1st, 2018-Apri ...[more]

PMID: 35316509

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Project description:BackgroundDelivering self-management support to people with type 2 diabetes mellitus is essential to reduce the health system burden and to empower people with the skills, knowledge, and confidence needed to take an active role in managing their own health.ObjectiveThis study aims to evaluate the adoption, use, and effectiveness of the My Diabetes Coach (MDC) program, an app-based interactive embodied conversational agent, Laura, designed to support diabetes self-management in the home setting over 12 months.MethodsThis randomized controlled trial evaluated both the implementation and effectiveness of the MDC program. Adults with type 2 diabetes in Australia were recruited and randomized to the intervention arm (MDC) or the control arm (usual care). Program use was tracked over 12 months. Coprimary outcomes included changes in glycated hemoglobin (HbA1c) and health-related quality of life (HRQoL). Data were assessed at baseline and at 6 and 12 months, and analyzed using linear mixed-effects regression models.ResultsA total of 187 adults with type 2 diabetes (mean 57 years, SD 10 years; 41.7% women) were recruited and randomly allocated to the intervention (n=93) and control (n=94) arms. MDC program users (92/93 participants) completed 1942 chats with Laura, averaging 243 min (SD 212) per person over 12 months. Compared with baseline, the mean estimated HbA1c decreased in both arms at 12 months (intervention: 0.33% and control: 0.20%), but the net differences between the two arms in change of HbA1c (-0.04%, 95% CI -0.45 to 0.36; P=.83) was not statistically significant. At 12 months, HRQoL utility scores improved in the intervention arm, compared with the control arm (between-arm difference: 0.04, 95% CI 0.00 to 0.07; P=.04).ConclusionsThe MDC program was successfully adopted and used by individuals with type 2 diabetes and significantly improved the users' HRQoL. These findings suggest the potential for wider implementation of technology-enabled conversation-based programs for supporting diabetes self-management. Future studies should focus on strategies to maintain program usage and HbA1c improvement.Trial registrationAustralia New Zealand Clinical Trials Registry (ACTRN) 12614001229662; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12614001229662.

Project description:BackgroundThe majority of people with type 2 diabetes who require insulin therapy use only basal insulin in combination with other anti-diabetic agents. We tested whether using a smartphone application to titrate insulin could improve glycaemic control in people with type 2 diabetes who use basal insulin.MethodsThis was a 12-week, multicentre, open-label, parallel, randomised controlled trial conducted in 36 diabetes practices in Germany. Eligible participants had type 2 diabetes, a BMI ≥25.0 kg/m2, were on basal insulin therapy or were initiating basal insulin therapy, and had suboptimal glycaemic control (HbA1c >7.5%; 58.5 mmol/mol). Block randomisation with 1:1 allocation was performed centrally. Participants in the intervention group titrated their basal insulin dose using a smartphone application (My Dose Coach) for 12 weeks. Control group participants titrated their basal insulin dose according to a written titration chart. The primary outcome was the baseline-adjusted change in HbA1c at 12 weeks. The intention-to-treat analysis included all randomised participants.ResultsBetween 13 July 2021 and 21 March 2022, 251 study participants were randomly assigned (control group: n = 123; intervention group: n = 128), and 236 completed the follow-up phase (control group: n = 119; intervention group: n = 117). Regarding the HbA1c a model-based adjusted between-group difference of -0.31% (95% CI: 0.01%-0.69%; p = 0.0388) in favour of the intervention group was observed. There were 30 adverse events reported: 16 in the control group, 14 in the intervention group. Of these, 15 adverse events were serious. No event was considered to be related to the investigational device.InterpretationStudy results suggest that utilizing this digital health smartphone application for basal insulin titration may have resulted in a comparatively greater reduction in HbA1c levels among individuals with type 2 diabetes, as compared to basal insulin titration guided by a written titration schedule. No negative effect on safety outcomes was observed.FundingSanofi-Aventis Deutschland GmbH.

Project description:Background As diabetes self-management necessitates life-long learning, behaviour change, support, and monitoring, health coaching is a promising intervention to assist individuals in more than just meeting glycemic goals and glycated hemoglobin (A1C) targets. Currently, studies of health coaching for type 2 diabetes (T2DM) are limited due to their emphasis on glycemic control. The goal of this systematic review and meta-analysis is to determine the effects of health coaching on adults with T2DM based on quadruple aim outcomes and to assess the implementation of these interventions. Methods We searched 6 databases for randomized controlled trials of health coaching interventions delivered by a health professional for adults with T2DM. Reviewers screened citations, extracted data, and assessed risk of bias and certainty of evidence (GRADE). We assessed statistical and methodological heterogeneity and performed a meta−analysis of studies. Results Nine studies were included in this review. Our meta-analysis showed a significant reduction of A1C [0.24 (95% CI, -0.38 to -0.09)] after exposure to diabetes health coaching, and small to trivial significant benefits for BMI, waist circumference, body weight, and depression/distress immediately post intervention based on moderate certainty of evidence. However, long term benefit of these clinical outcomes were not maintained at follow-up timepoints. There was a small significant benefit for systolic blood pressure which was maintained after the completion of health coaching exposure at follow-up, but there was no statistically significant benefit in other secondary outcomes such as diastolic blood pressure and lipid profile measures (e.g. triglycerides). Very few studies reported on other quadruple aim measures such as patient-reported outcomes, cost of care, and healthcare provider experience. Conclusions Our systematic review and meta-analysis shows that health coaching interventions can have short term impact beyond glucose control on cardiometabolic and mental health outcomes. Future studies should try to examine quadruple aim outcomes to better assess the benefit and impact of these interventions at longer time points and following termination of the coaching program. Systematic Review Registration https://www.crd.york.ac.uk/prospero, identifier (CRD42022347478).

Project description:BackgroundWith widespread smartphone ownership, mobile health apps (mHealth) can expand access to evidence-based interventions for mental health conditions, including posttraumatic stress disorder (PTSD). Research to evaluate new features and capabilities in these apps is critical but lags behind app development. The initial release of PTSD Coach, a free self-management app developed by the US Departments of Veterans Affairs and Defense, was found to have a positive public health impact. However, major stakeholder-driven updates to the app have yet to be evaluated.ObjectiveWe aimed to characterize the reach, use, and potential impact of PTSD Coach Version 3.1 in the general public. As part of characterizing use, we investigated the use of specific app features, which extended previous work on PTSD Coach.MethodsWe examined the naturalistic use of PTSD Coach during a 1-year observation period between April 20, 2020, and April 19, 2021, using anonymous in-app event data to generate summary metrics for users.ResultsDuring the observation period, PTSD Coach was broadly disseminated to the public, reaching approximately 150,000 total users and 20,000 users per month. On average, users used the app 3 times across 3 separate days for 18 minutes in total, with steep drop-offs in use over time; a subset of users, however, demonstrated high or sustained engagement. More than half of users (79,099/128,691, 61.46%) accessed one or more main content areas of the app (ie, Manage Symptoms, Track Progress, Learn, or Get Support). Among content areas, features under Manage Symptoms (including coping tools) were accessed most frequently, by over 40% of users (53,314/128,691, 41.43% to 56,971/128,691, 44.27%, depending on the feature). Users who provided initial distress ratings (56,971/128,691, 44.27%) reported relatively high momentary distress (mean 6.03, SD 2.52, on a scale of 0-10), and the use of a coping tool modestly improved momentary distress (mean -1.38, SD 1.70). Among users who completed at least one PTSD Checklist for DSM-5 (PCL-5) assessment (17,589/128,691, 13.67%), PTSD symptoms were largely above the clinical threshold (mean 49.80, SD 16.36). Among users who completed at least two PCL-5 assessments (4989/128,691, 3.88%), PTSD symptoms decreased from the first to last assessment (mean -4.35, SD 15.29), with approximately one-third (1585/4989, 31.77%) of these users experiencing clinically significant improvements.ConclusionsPTSD Coach continues to fulfill its mission as a public health resource. Version 3.1 compares favorably with version 1 on most metrics related to reach, use, and potential impact. Although benefits appear modest on an individual basis, the app provides these benefits to a large population. For mHealth apps to reach their full potential in supporting trauma recovery, future research should aim to understand the utility of individual app features and identify strategies to maximize overall effectiveness and engagement.

Project description:ImportanceTreatment challenges exist for younger adults with type 1 (T1D) and type 2 diabetes (T2D). Health care coverage, access to, and use of diabetes care are not well delineated in these high-risk populations.ObjectiveTo compare patterns of health care coverage, access to, and use of diabetes care and determine their associations with glycemia among younger adults with T1D and with T2D.Design, setting, and participantsThis cohort study analyzed data from a survey that was jointly developed by 2 large, national cohort studies: the SEARCH for Diabetes in Youth (SEARCH) study, an observational study of individuals with youth-onset T1D or T2D, and the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study, a randomized clinical trial (2004-2011) followed by an observational study (2012-2020). The interviewer-directed survey was administered during in-person study visits in both studies between 2017 and 2019. Data analyses were performed between May 2021 and October 2022.Main outcomes and measuresSurvey questions addressed health care coverage, usual sources of diabetes care, and frequency of care use. Glycated hemoglobin (HbA1c) levels were assayed in a central laboratory. Patterns of health care factors and HbA1c levels were compared by diabetes type.ResultsThe analysis included 1371 participants (mean [range] age, 25 [18-36] years; 824 females [60.1%]), of whom 661 had T1D and 250 had T2D from the SEARCH study and 460 had T2D from the TODAY study. Participants had a mean (SD) diabetes duration of 11.8 (2.8) years. More participants with T1D than T2D in both the SEARCH and TODAY studies reported health care coverage (94.7%, 81.6%, and 86.7%), access to diabetes care (94.7%, 78.1%, and 73.4%), and use of diabetes care (88.1%, 80.5%, and 73.6%). Not having health care coverage was associated with significantly higher mean (SE) HbA1c levels in participants with T1D in the SEARCH study (no coverage, 10.8% [0.5%]; public, 9.4% [0.2%]; private, 8.7% [0.1%]; P < .001) and participants with T2D from the TODAY study (no coverage, 9.9% [0.3%]; public, 8.7% [0.2%]; private, 8.7% [0.2%]; P = .004). Medicaid expansion vs without expansion was associated with more health care coverage (participants with T1D: 95.8% vs 90.2%; participants with T2D in SEARCH: 86.1% vs 73.9%; participants with T2D in TODAY: 93.6% vs 74.2%) and lower HbA1c levels (participants with T1D: 9.2% vs 9.7%; participants with T2D in SEARCH: 8.4% vs 9.3%; participants with T2D in TODAY: 8.7% vs 9.3%). The T1D group incurred higher median (IQR) monthly out-of-pocket expenses than the T2D group ($74.50 [$10.00-$309.00] vs $10.00 [$0-$74.50]).Conclusions and relevanceResults of this study suggested that lack of health care coverage and of an established source of diabetes care were associated with significantly higher HbA1c levels for participants with T1D, but inconsistent results were found for participants with T2D. Increased access to diabetes care (eg, through Medicaid expansion) may be associated with improved health outcomes, but additional strategies are needed, particularly for individuals with T2D.

Dataset Information

Impact of My Dose Coach App Frequency of Use on Clinical Outcomes in Type 2 Diabetes.

Introduction

Methods

Results

Conclusions

Publications

Impact of My Dose Coach App Frequency of Use on Clinical Outcomes in Type 2 Diabetes.

Similar Datasets

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