Digital Therapeutics for Type 2 Diabetes: Incorporating Coaching Support and Validating Digital Monitoring.
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ABSTRACT:
SUBMITTER: Fundoiano-Hershcovitz Y
PROVIDER: S-EPMC8442174 | biostudies-literature | 2021 Sep
REPOSITORIES: biostudies-literature
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Digital Therapeutics for Type 2 Diabetes: Incorporating Coaching Support and Validating Digital Monitoring.
Fundoiano-Hershcovitz Yifat Y Feniger Eitan E Dar Sharon S Ritholz Marilyn M Schorr Allan B AB Goldstein Pavel P
Journal of diabetes science and technology 20210522 5
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Project description:Post-cessation weight gain (PCWG) facilitates short-term type 2 diabetes (T2D) risk in prediabetic smokers in the absence of complementary measures. In this shared decision-making-based non-randomized controlled trial, prediabetic smokers joined the Fight Tobacco and Stay Fit (FIT2) program or received usual care. The 16-week FIT2 program combined smoking cessation therapy with individualized coaching in diet and physical activity strategies for PCWG restriction (NCT01926041 at ClinicalTrials.gov). During a mean follow-up period of 1316 days, 217 participants (36.8%) developed T2D, and 68 (11.5%) regressed to normoglycemia. In the intention-to-treat analysis (n = 589), the FIT2 program was associated with a reduced T2D risk (HR, 0.58; 95% CI, 0.40-0.84) and a higher probability of regression to normoglycemia (HR, 1.91; 95% CI, 1.04-3.53) compared with usual care. The post-program quitters were at lower T2D risk (HR, 0.63; 95% CI, 0.44-0.92) and were more likely to regress to normoglycemia (HR, 1.83; 95% CI, 1.01-3.30) compared with the controls in the time-varying analysis (n = 532). We demonstrated that the FIT2 program was negatively associated with long-term T2D risk and positively associated with the probability of regression to normoglycemia compared with usual care. To prevent T2D development, we recommend simultaneously promoting smoking abstinence and lifestyle coaching for PCWG restriction.
| S-EPMC8539112 | biostudies-literature
Project description:The increasing prevalence of metabolic syndrome and type 2 diabetes places a burden on healthcare systems, necessitating cost-effective, engaging and accessible interventions to address the underlying behavioral and lifestyle drivers. Our study evaluated combining Bluetooth connected OneTouch blood glucose meters (BGM) and the OneTouch Reveal mobile app with one of four digital therapeutic apps. Each group was independent, with people with type 2 diabetes (PwT2D) themselves choosing their therapeutic intervention, to better reflect real-world use. Our 3-month decentralized study screened 912 subjects, with 612 returning mail-in A1cs, providing 191 subjects (Noom = 68, Fitbit = 31, Cecelia Health = 47, Welldoc = 45) who met all inclusion criteria, including entry A1c 7.5 to 12.0%. The primary endpoint of A1c change showed improvement in the overall group by - 0.77% (95% CI - 0.98 to - 0.56, n = 141) after 3-months, Noom - 1.03% (CI - 1.4 to - 0.61, n = 49), Fitbit - 0.56% (CI - 1.0 to - 0.11, n = 24), Cecelia Health - 0.76% (CI - 1.2 to - 0.36, n = 36), Welldoc - 0.55% (CI - 0.94 to - 0.17, n = 32). In terms of secondary endpoints, more than half (56%) of these PwT2D lowered A1c by ≥ 0.5% and more than a third (36%) lowered A1c by ≥ 1.0%, with similar improvements across each of the four independent groups. Our real-world approach shows the potential for connected BGMs and widely accessible digital therapeutics to contribute to improvements in glycemic outcomes.
| S-EPMC11909182 | biostudies-literature
Project description:Digital health coaching is an intervention for type 2 diabetes mellitus (T2DM) that has potential to improve the quality of care for patients. Previous research has established the efficacy of digital interventions for behavior change. This pilot study addresses a research gap in finding effective and accessible behavioral interventions for under-resourced individuals with T2DM. We examined the impact of Healthy at Home, a 12-week phone and SMS-based (short message service) digital health coaching program, on insulin resistance which is an upstream marker for T2DM progression. We compared this intervention to usual diabetic care in a family medicine residency clinic in a randomized controlled trial. Digital health coaching significantly improved participants' calculated Homeostatic Model Assessment for Insulin Resistance (HOMA2-IR) by -0.9 ± 0.4 compared with the control group (p = 0.029). This significance remained after controlling for years diagnosed with T2DM, enrollment in Medicaid, access to food, baseline stage of change, and race (p = 0.027). Increasing access to digital health coaching may lead to more effective control of diabetes for under-resourced patients. This study demonstrates the potential to implement a personalized, scalable, and effective digital health intervention to treat and manage T2DM through a lifestyle and behavioral approach to improve clinical outcomes (http://clinicaltrials.gov, NCT04872647).
| S-EPMC8655126 | biostudies-literature
Project description:Digital therapeutics (DTx) are a promising way to provide safe, effective, accessible, sustainable, scalable, and equitable approaches to advance individual and population health. However, developing and deploying DTx is inherently complex in that DTx includes multiple interacting components, such as tools to support activities like medication adherence, health behavior goal-setting or self-monitoring, and algorithms that adapt the provision of these according to individual needs that may change over time. While myriad frameworks exist for different phases of DTx development, no single framework exists to guide evidence production for DTx across its full life cycle, from initial DTx development to long-term use. To fill this gap, we propose the DTx real-world evidence (RWE) framework as a pragmatic, iterative, milestone-driven approach for developing DTx. The DTx RWE framework is derived from the 4-phase development model used for behavioral interventions, but it includes key adaptations that are specific to the unique characteristics of DTx. To ensure the highest level of fidelity to the needs of users, the framework also incorporates real-world data (RWD) across the entire life cycle of DTx development and use. The DTx RWE framework is intended for any group interested in developing and deploying DTx in real-world contexts, including those in industry, health care, public health, and academia. Moreover, entities that fund research that supports the development of DTx and agencies that regulate DTx might find the DTx RWE framework useful as they endeavor to improve how DTxcan advance individual and population health.
| S-EPMC10951831 | biostudies-literature
Project description:BackgroundBehavioral interventions can meaningfully improve cardiometabolic conditions. Digital therapeutics (DTxs) delivering these interventions may provide benefits comparable to pharmacologic therapies, displacing medications for some patients.ObjectiveOur objective was to estimate the economic impact of a digital behavioral intervention in type 2 diabetes mellitus (T2DM) and hypertension (HTN) and estimate the impact of clinical inertia on deprescribing medications.MethodsDecision analytic models estimated health resource savings and cost effectiveness from a US commercial payer perspective. A 3-year time horizon was most relevant to the intervention and payer. Effectiveness of the DTx in improving clinical outcomes was based on cohort studies and published literature. Health resource utilization (HRU), health state utilities, and costs were drawn from the literature with costs adjusted to 2018 dollars. Future costs and quality-adjusted life years (QALYs) were discounted at 3%. Sensitivity analyses assessed uncertainty.ResultsAverage HRU savings ranged from $97 to $145 per patient per month, with higher potential benefits in T2DM. Cost-effectiveness acceptability analyses using a willingness-to-pay of $50,000/QALY indicated that the intervention would be cost effective at total 3-year program costs of $6468 and $6620 for T2DM and HTN, respectively. Sensitivity analyses showed that reduced medication costs are a primary driver of potential HRU savings, and the results were robust within values tested. A resistance to deprescribe medications when a patient's clinical outcomes improve can substantially reduce the estimated economic benefits. Our models rely on estimates of clinical effectiveness drawn from limited cohort studies with DTxs and cannot account for other disease management programs that may be implemented. Performance of DTxs in real-world settings is required to further validate their economic benefits.ConclusionsThe DTxs studied may provide substantial cost savings, in part by reducing the use of conventional medications. Clinical inertia may limit the full cost savings of DTxs.
| S-EPMC6914106 | biostudies-literature
Project description:BackgroundType 2 diabetes mellitus (T2DM) is a leading cause of morbidity and mortality globally, with adverse health consequences largely related to hyperglycemia. Despite clinical practice guideline recommendations, effective pharmacotherapy, and interventions to support patients and providers, up to 60% of patients diagnosed with T2DM are estimated to have hemoglobin A1c (HbA1c) levels above the recommended targets owing to multilevel barriers hindering optimal glycemic control.ObjectiveThe aim of this study is to compare changes in HbA1c levels among patients with suboptimally controlled T2DM who were offered the opportunity to use an intermittently viewed continuous glucose monitor and receive personalized low-carbohydrate nutrition counseling (<100 g/day) versus those who received usual care (UC).MethodsThis was a 12-month, pragmatic, randomized quality improvement program. All adult patients with T2DM who received primary care at a university-affiliated primary care clinic (N=1584) were randomized to either the UC or the enhanced care (EC) group. Within each program arm, we identified individuals with HbA1c >7.5% (58 mmol/mol) who were medically eligible for tighter glycemic control, and we defined these subgroups as UC-high risk (UC-HR) or EC-HR. UC-HR participants (n=197) received routine primary care. EC-HR participants (n=185) were invited to use an intermittently viewed continuous glucose monitor and receive low-carbohydrate nutrition counseling. The primary outcome was mean change in HbA1c levels from baseline to 12 months using an intention-to-treat difference-in-differences analysis comparing EC-HR with UC-HR groups. We conducted follow-up semistructured interviews to understand EC-HR participant experiences with the intervention.ResultsHbA1c decreased by 0.41% (4.5 mmol/mol; P=.04) more from baseline to 12 months among participants in the EC-HR group than among those in UC-HR; however, only 61 (32.9%) of 185 EC-HR participants engaged in the program. Among the EC-HR participants who wore continuous glucose monitors (61/185, 32.9%), HbA1c was 1.1% lower at 12 months compared with baseline (P<.001). Interviews revealed themes related to EC-HR participants' program engagement and continuous glucose monitor use.ConclusionsAmong patients with suboptimally controlled T2DM, a combined approach that includes continuous glucose monitoring and low-carbohydrate nutrition counseling can improve glycemic control compared with the standard of care.
| S-EPMC8851329 | biostudies-literature
Project description:Many individuals in need of mental health services do not currently receive care. Scalable programs are needed to reduce the burden of mental illness among those without access to existing providers. Digital interventions present an avenue for increasing the reach of mental health services. These interventions often rely on paraprofessionals, or coaches, to support the treatment. Although existing programs hold immense promise, providers must ensure that treatments are delivered with high fidelity and adherence to the treatment model. In this paper, we first highlight the tension between the scalability and fidelity of mental health services. We then describe the design and implementation of a peer-to-peer coach training program to support a digital mental health intervention for undergraduate students within a university setting. We specifically note strategies for emphasizing fidelity within our scalable framework, including principles of learning theory and competency-based supervision. Finally, we discuss future applications of this work, including the potential adaptability of our model for use within other contexts.
| S-EPMC8829693 | biostudies-literature
Project description:BackgroundFailure to take medicines for diabetes as prescribed contributes to poor outcomes from the condition. Mobile phones are ubiquitous and short message service (SMS) texts have shown promise as a low-cost intervention. We tested the effectiveness of SMS-text messaging in improving outcomes in adults with type 2 diabetes.MethodsStAR2D was a 12-month two-arm randomised trial of SMS-text messaging and usual care in Cape Town, South Africa and Lilongwe, Malawi. Messages used behaviour change theory and were developed with patients and staff. The intervention group received four messages each week. The primary outcome was change in HbA1c. Secondary outcomes were the proportion of patients who collected > 80% medication and changes in systolic blood pressure, lipids, cardiovascular risk, and the proportion of the participants reaching treatment goals.ResultsThe trial took place between 1 October, 2016 and 1 October 2018, 1186 participants were randomised to intervention (593) and control (593) groups. 91% of participants completed follow-up. There was a reduction in HbA1c (DCCT) in both groups but not in mean change (95% CI) between groups (- 0.08% (- 0.31 to 0.16) (IFCC - 0.82 mmol/mol (- 3.44 to 1.79). There was a small but not significant increase in the proportions of participants likely to have collected 80% or more of medication (Relative risk 1.11 (0.84 to 1.47; P = 0.47). There was a significant difference between groups in change in systolic blood pressure from baseline of 3.46 mmHg (1.48 to 5.44, P = 0.001) in favour of the intervention group. The between group difference in change in 10-year risk of coronary heart disease was - 0.71% (- 1.46 to 0.04, P = 0.064). The proportion of participants meeting treatment goals in the intervention group was 36.0% and in the control group 26.8% (Relative risk 1.36 (1.13 to 1.63, P = 0.001). Participants reported many challenges to adherence despite finding messages acceptable and useful.ConclusionsWhilst SMS text messages do not lead to improved glycaemia in these low-resource settings there appeared to be an impact on blood pressure and achievement of treatment goals but the mechanisms for this are unclear. Text messages alone, may be unsuccessful unless accompanied by health system strengthening and other forms of self-management support for type 2 diabetes.Trial registrationTrial registration: ISRCTN, ISRCTN70768808. Registered 1 July 2015, http://www.isrctn.com/I ISRCTN70768808.
| S-EPMC8529732 | biostudies-literature
Project description:BackgroundConnected health devices with lifestyle coaching can provide real-time support for people with type 2 diabetes (T2D). However, the intensity of lifestyle coaching needed to achieve outcomes is unknown.MethodsLivongo provides connected, two-way messaging glucose meters, unlimited blood glucose (BG) test strips, and access to certified diabetes educators. We evaluated the incremental effects of adding lifestyle coaching on BG, estimated HbA1c, and weight. We randomized 330 eligible adults (T2D, HbA1c > 7.5%, BMI ≥ 25) to receive no further intervention (n = 75), a connected scale (n = 115), scale plus lightweight coaching (n = 73), or scale plus intense coaching (n = 67) for 12 weeks. We evaluated the change in outcomes using ANOVA.ResultsLivongo participation alone resulted in improved BG control (mean HbA1c declined: 8.5% to 7.5%, p = 0.01). Mean weight loss and additional BG decreases were higher in the intensive compared with the lightweight coaching and scale-only groups (weight change (lb): -6.4, -4.1, and -1.1, resp., p = 0.01; BG change (mg/dL): -19.4, -11.3, and -2.9, resp., p = 0.02). The estimated 12-week program costs were 5.5 times more for intensive than lightweight coaching.ConclusionLivongo participation significantly improves BG control in people with T2D. Additional lifestyle coaching may be a cost-effective intervention to achieve further glucose control and weight loss.
| S-EPMC5977036 | biostudies-literature
Project description:ObjectivePilot-test personalized digital health information to substantiate human-delivered exercise support for adults with type 1 diabetes (T1D).DesignSingle-group, 2-week baseline observation, then 10-week intervention with follow-up observation.SettingCommunity-based sample participating remotely with physician oversight.ParticipantsVolunteers aged 18 to 65 years with T1D screened for medical readiness for exercise intervention offerings. N = 20 enrolled, and N = 17 completed all outcomes with 88% to 91% biosensor adherence.InterventionFeedback on personalized data from continuous glucose monitoring (CGM), its intersection with other ecological data sets (exercise, mood, and sleep), and other informational and motivational elements (exercise videos, text-based exercise coach, and self-monitoring diary).Main outcome measuresFeasibility (use metrics and assessment completion), safety (mild and severe hypoglycemia, and diabetic ketoacidosis), acceptability (system usability scale, single items, and interview themes), and standard clinical and psychosocial assessments.ResultsParticipants increased exercise from a median of 0 (Interquartile range, 0-21) to 64 (20-129) minutes per week ( P = 0.001, d = 0.71) with no severe hypoglycemia or ketoacidosis. Body mass index increased (29.5 ± 5.1 to 29.8 ± 5.4 kg/m 2 , P = 0.02, d = 0.57). Highest satisfaction ratings were for CGM use (89%) and data on exercise and its intersection with CGM and sleep (94%). Satisfaction was primarily because of improved exercise management behavioral skills, although derived motivation was transient.ConclusionsThe intervention was feasible, safe, and acceptable. However, there is a need for more intensive, sustained support. Future interventions should perform analytics upon the digital health information and molecular biomarkers (eg, genomics) to make exercise support tools that are more personalized, automated, and intensive than our present offerings.
| S-EPMC10898917 | biostudies-literature