Dataset Information

The Mobile Insulin Titration Intervention (MITI) for Insulin Glargine Titration in an Urban, Low-Income Population: Randomized Controlled Trial Protocol.

ABSTRACT: BACKGROUND:Patients on insulin glargine typically visit a clinician to obtain advice on how to adjust their insulin dose. These multiple clinic visits can be costly and time-consuming, particularly for low-income patients. It may be feasible to achieve insulin titration through text messages and phone calls with patients instead of face-to-face clinic visits. OBJECTIVE:The objectives of this study are to (1) evaluate if the Mobile Insulin Titration Intervention (MITI) is clinically effective by helping patients reach their optimal dose of insulin glargine, (2) determine if the intervention is feasible within the setting and population, (3) assess patient satisfaction with the intervention, and (4) measure the costs associated with this intervention. METHODS:This is a pilot study evaluating an approach to insulin titration using text messages and phone calls among patients with insulin-dependent type 2 diabetes in the outpatient medical clinic of Bellevue Hospital Center, a safety-net hospital in New York City. Patients will be randomized in a 1:1 ratio to either the MITI arm (texting/phone call intervention) or the usual-care arm (in-person clinic visits). Using a Web-based platform, weekday text messages will be sent to patients in the MITI arm, asking them to text back their fasting blood glucose values. In addition to daily reviews for alarm values, a clinician will rereview the texted values weekly, consult our physician-approved titration algorithm, and call the patients with advice on how to adjust their insulin dose. The primary outcome will be whether or not a patient reaches his/her optimal dose of insulin glargine within 12 weeks. RESULTS:Recruitment for this study occurred between June 2013 and December 2014. We are continuing to collect intervention and follow-up data from our patients who are currently enrolled. The results of our data analysis are expected to be available in 2015. CONCLUSIONS:This study explores the use of widely-available text messaging and voice technologies for insulin titration. We aim to show that remote insulin titration is clinically effective, feasible, satisfactory, and cost saving for low-income patients in a busy, urban clinic. TRIAL REGISTRATION:Clinicaltrials.gov NCT01879579; http://clinicaltrials.gov/ct2/show/NCT01879579 (Archived by WebCite at http://www.webcitation.org/6WUEgjZUO).

SUBMITTER: Levy N

PROVIDER: S-EPMC4381814 | biostudies-literature | 2015 Mar

REPOSITORIES: biostudies-literature

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The Mobile Insulin Titration Intervention (MITI) for Insulin Glargine Titration in an Urban, Low-Income Population: Randomized Controlled Trial Protocol.

Levy Natalie N Moynihan Victoria V Nilo Annielyn A Singer Karyn K Bernik Lidia S LS Etiebet Mary-Ann MA Fang Yixin Y Cho James J Natarajan Sundar S

JMIR research protocols 20150313 1

<h4>Background</h4>Patients on insulin glargine typically visit a clinician to obtain advice on how to adjust their insulin dose. These multiple clinic visits can be costly and time-consuming, particularly for low-income patients. It may be feasible to achieve insulin titration through text messages and phone calls with patients instead of face-to-face clinic visits.<h4>Objective</h4>The objectives of this study are to (1) evaluate if the Mobile Insulin Titration Intervention (MITI) is clinicall ...[more]

PMID: 25794243

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Project description:Diabetes patients are usually started on a low dose of insulin and their dose is adjusted or "titrated" according to their blood glucose levels. Insulin titration administered through face-to-face visits with a clinician can be time consuming and logistically burdensome for patients, especially those of low socioeconomic status (SES). Given the wide use of mobile phones among this population, there is the potential to use short message service (SMS) text messaging and phone calls to perform insulin titration remotely.The goals of this pilot study were to (1) evaluate if our Mobile Insulin Titration Intervention (MITI) intervention using text messaging and phone calls was effective in helping patients reach their optimal insulin glargine dose within 12 weeks, (2) assess the feasibility of the intervention within our clinic setting and patient population, (3) collect data on the cost savings associated with the intervention, and (4) measure patient satisfaction with the intervention.This was a pilot study evaluating an intervention for patients requiring insulin glargine titration in the outpatient medical clinic of Bellevue Hospital Center in New York City. Patients in the intervention arm received weekday SMS text messages from a health management platform requesting their fasting blood glucose values. The clinic's diabetes nurse educator monitored the texted responses on the platform website each weekday for alarm values. Once a week, the nurse reviewed the glucose values, consulted the MITI titration algorithm, and called patients to adjust their insulin dose. Patients in the usual care arm continued to receive their standard clinic care for insulin titration. The primary outcome was whether a patient reached his/her optimal insulin glargine dose within 12 weeks.A total of 61 patients consented and were randomized into the study. A significantly greater proportion of patients in the intervention arm reached their optimal insulin glargine dose than patients in the usual care arm (88%, 29/33 vs 37%, 10/27; P<.001). Patients responded to 84.3% (420/498) of the SMS text messages requesting their blood glucose values. The nurse reached patients within 2 attempts or by voicemail 91% of the time (90/99 assigned calls). When patients traveled to the clinic, they spent a median of 45 minutes (IQR 30-60) on travel and 39 minutes (IQR 30-64) waiting prior to appointments. A total of 61% (37/61) of patients had appointment copays. After participating in the study, patients in the intervention arm reported higher treatment satisfaction than those in the usual care arm.MITI is an effective way to help low-SES patients reach their optimal insulin glargine dose using basic SMS text messaging and phone calls. The intervention was feasible and patients were highly satisfied with their treatment. The intervention was cost saving in terms of time for patients, who were able to have their insulin titrated without multiple clinic appointments. Similar interventions should be explored to improve care for low-SES patients managing chronic disease.Clinicaltrials.gov NCT01879579; https://clinicaltrials.gov/ct2/show/NCT01879579 (Archived by WebCite at http://www.webcitation.org/6YZik33L3).

Project description:BackgroundIn 2016, a short message service text messaging intervention to titrate insulin in patients with uncontrolled type 2 diabetes was implemented at two health care facilities in New York City.ObjectiveThis study aimed to conduct a qualitative evaluation assessing barriers to and the facilitators of the implementation of the Mobile Insulin Titration Intervention (MITI) program into usual care.MethodsWe conducted in-depth interviews with 36 patients enrolled in the MITI program and the staff involved in MITI (n=19) in the two health care systems. Interviews were transcribed and iteratively coded by two study investigators, both inductively and deductively using a codebook guided by the Consolidated Framework for Implementation Research.ResultsMultiple facilitator themes emerged: (1) MITI had strong relative advantages to in-person titration, including its convenience and time-saving design, (2) the free cost of MITI was important to the patients, (3) MITI was easy to use and the patients were confident in their ability to use it, (4) MITI was compatible with the patients' home routines and clinic workflow, (5) the patients and staff perceived MITI to have value beyond insulin titration by reminding and motivating the patients to engage in healthy behaviors and providing a source of patient support, and (6) implementation in clinics was made easy by having a strong implementation climate, communication networks to spread information about MITI, and a strong program champion. The barriers identified included the following: (1) language limitations, (2) initial nurse concerns about the scope of practice changes required to deliver MITI, (3) initial provider knowledge gaps about the program, and (4) provider perceptions that MITI might not be appropriate for some patients (eg, older or not tech-savvy). There was also a theme that emerged during the patient and staff interviews of an unmet need for long-term additional diabetes management support among this population, specifically diet, nutrition, and exercise support.ConclusionsThe patients and staff were overwhelmingly supportive of MITI and believed that it had many benefits and that it was compatible with the clinic workflow and patients' lives. Initial implementation efforts should address staff training and nurse concerns. Future research should explore options for integrating additional diabetes support for patients.

Project description:BackgroundAfrican Americans suffer more than non-Hispanic whites from type 2 diabetes, but diabetes self-management education (DSME) has been less effective at improving glycemic control for African Americans. Our objective was to determine whether a novel, culturally tailored DSME intervention would result in sustained improvements in glycemic control in low-income African-American patients of public hospital clinics.Research design and methodsThis randomized controlled trial (n = 211) compared changes in hemoglobin A1c (A1c) at 6, 12, and 18 months between two arms: (1) Lifestyle Improvement through Food and Exercise (LIFE), a culturally tailored, 28-session community-based intervention, focused on diet and physical activity, and (2) a standard of care comparison group receiving two group DSME classes. Cluster-adjusted ANCOVA modeling was used to assess A1c changes from baseline to 6, 12, and 18 months, respectively, between arms.ResultsAt 6 months, A1c decreased significantly more in the intervention group than the control group (- 0.76 vs - 0.21%, p = 0.03). However, by 12 and 18 months, the difference was no longer significant (12 months - 0.63 intervention vs - 0.45 control, p = 0.52). There was a decrease in A1c over 18 months in both the intervention (β = - 0.026, p = 0.003) and the comparison arm (β = - 0.018, p = 0.048) but no difference in trend (p = 0.472) between arms. The intervention group had greater improvements in nutrition knowledge (11.1 vs 6.0 point change, p = 0.002) and diet quality (4.0 vs - 0.5 point change, p = 0.018) while the comparison group had more participants with improved medication adherence (24% vs 10%, p < 0.05) at 12 months.ConclusionsThe LIFE intervention resulted in improved nutrition knowledge and diet quality and the comparison intervention resulted in improved medication adherence. LIFE participants showed greater A1c reduction than standard of care at 6 months but the difference between groups was no longer significant at 12 and 18 months.Nih trial registry numberNCT01901952.

Project description:BackgroundDigital technology is a means to uphold or violate human rights in various domains, including business, military, and health. Given the pervasiveness of mobile technology in low- and middle-income countries (LMICs), mobile health (mHealth) interventions present an opportunity to reach remote populations and enable them to exercise civil and political rights and economic, social, and cultural rights, such as the right to health and education. Simultaneously, the ubiquity of mobile phones involves processing sensitive data which can threaten rights, including the right to privacy and nondiscrimination. Digital health is often promoted as advancing human rights and health equity; however, digital rights are underexplored in the literature on mHealth in LMICs. As such, creating an understanding of the digital rights topics covered in the 2022 literature is important to avoid exacerbating existing inequities relating to digital health design, use, implementation, and access.ObjectiveThis scoping review aims to identify digital rights topics in the 2022 peer-reviewed literature on mHealth in LMICs.MethodsThe Arksey and O'Malley framework for scoping reviews guides this review. Searches were performed across 7 electronic databases (Web of Science, Scopus, Ovid, ACM Digital Library, IEEE Xplore, ProQuest, and PubMed). The screening processes were guided by the research question "What digital rights topics have been explored in the 2022 literature on mHealth in LMICs?" Only papers addressing mHealth in LMICs and digital rights topics were included. Data extraction will include publication title, year, and type; first author's affiliation country; LMICs implicated; infrastructure challenges; study aims, design, limitations, and future work; health area; mHealth technology, functions, purpose or application, and target end users; human or digital right terms used; explicit rights topics cited; and implied rights topics. The results will be reported using the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) checklist.ResultsThis scoping review was registered in Open Science Framework (December 22, 2022). Title and abstract screening and full-text paper screening were completed in 2023. This resulted in 56 papers being included in the study. The target date for completing data extraction and publishing a case study of the initial findings is the end of 2023. The full scoping review findings are expected to be disseminated through various pathways benefiting academia, practice, and policy making by the end of 2024. These include journal papers, conference presentations, publicly available toolkits for research and practice, public webinars, and policy briefs with evidence-based policy recommendations emerging from this review.ConclusionsThe planned scoping review will identify digital rights topics in the 2022 literature at the intersection of mHealth and LMICs. Furthermore, it will highlight the importance of patient empowerment, data protection, and inclusion in mHealth research and related policies in LMICs.Trial registrationOpen Science Framework osf.io/7mz24; https://osf.io/7mz24.International registered report identifier (irrid)DERR1-10.2196/49150.

Dataset Information

The Mobile Insulin Titration Intervention (MITI) for Insulin Glargine Titration in an Urban, Low-Income Population: Randomized Controlled Trial Protocol.

Publications

The Mobile Insulin Titration Intervention (MITI) for Insulin Glargine Titration in an Urban, Low-Income Population: Randomized Controlled Trial Protocol.

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