Improvements in Glycemic Control and Depressive Symptoms Among Adults With Type 2 Diabetes: Retrospective Study.

BACKGROUND: The prevalence of diabetes remains high, with traditional lifestyle interventions demonstrating limited success in improving diabetes-related outcomes, particularly among individuals with diabetes-related mental health comorbidities. Digital health interventions provide the ability to ease the sustained and rigorous self-management needs associated with diabetes care and treatment. Current interventions though, are plagued by small sample sizes, underpowered pilot studies, and immense heterogeneity in program intervention, duration, and measured outcomes. OBJECTIVE: Therefore, this work aimed to evaluate the effectiveness of a mobile health diabetes management program on measures of glycemic control in a high-risk population with type 2 diabetes (hemoglobin A1c [HbA1c] ≥8.0%), utilizing a sample of 1128 participants who provided baseline and follow-up data. The sustainability of this change in glycemic control was examined in a subset of participants (n=455) at 6 months and 1 year following program enrollment. A secondary analysis examined changes in glycemic control among a subset of participants with self-reported mild-to-moderate depression at baseline. METHODS: This study utilized a single-arm, retrospective design. Participants were enrolled in the Vida Health Diabetes Management Program. This app-based intervention utilized one-on-one remote sessions with a health coach, registered dietitian nutritionist, and/or a certified diabetes care and education specialist and structured lessons and tools related to diabetes management and self-care. Participants provided baseline (-365 to 21 days of program enrollment) as well as follow-up (at least 90 days following program enrollment) HbA1c values. Paired t tests were used to evaluate changes in HbA1c between baseline and follow-up time points. The 8-item Patient Health Questionnaire and the 7-item Generalized Anxiety Disorder Scale were utilized to assess self-reported depressive and anxiety symptoms, respectively. Paired t tests and linear regression modeling accounting for pertinent covariates were used to evaluate changes in mental health symptom acuity and their relationship with changes in glycemic control. RESULTS: We observed a significant decrease in HbA1c of -1.35 points between baseline (mean 9.84, SD 1.64) and follow-up (mean 8.48, SD 1.77; t=22.56, P<.001) among this large, high-risk sample. This decrease was sustained up to 1 year following program enrollment. Additionally, a significant relationship between improvements in depressive symptom acuity and improvements in HbA1c was observed (ß=-0.74, P=.03). CONCLUSIONS: This study demonstrates clinically meaningful improvements in glycemic control among participants enrolled in the Vida Health Diabetes Management Program. Additionally, this work presents one of the largest studied samples of participants enrolled in a digital health diabetes management program to date.

Changes in Glycemic Control Following Use of a Spanish-Language, Culturally Adapted Diabetes Program: Retrospective Study.

BACKGROUND: Several barriers to diabetes treatment and care exist, particularly in underserved medical communities. OBJECTIVE: This study aimed to evaluate a novel, culturally adapted, Spanish-language mHealth diabetes program for glycemic control. METHODS: Professional Spanish translators, linguists, and providers localized the entirety of the Vida Health Diabetes Management Program into a culturally relevant Spanish-language version. The Spanish-language Vida Health Diabetes Management Program was used by 182 (n=119 women) Spanish-speaking adults with diabetes. This app-based program provided access to culturally adapted educational content on diabetes self-management, one-on-one remote counseling and coaching sessions, and on-demand in-app messaging with bilingual (Spanish and English) certified health coaches, registered dietitian nutritionists, and certified diabetes care and education specialists. Hemoglobin A1c (HbA1c) was the primary outcome measure, and a 2-tailed, paired t test was used to evaluate changes in HbA1c before and after program use. To determine the relationship between program engagement and changes in glycemic control, a cluster-robust multiple regression analysis was employed. RESULTS: We observed a significant decrease in HbA1c of -1.23 points between baseline (mean 9.65%, SD 1.56%) and follow-up (mean 8.42%, SD 1.44%; P<.001). Additionally, we observed a greater decrease in HbA1c among participants with high program engagement (high engagement: -1.59%, SD 1.97%; low engagement: -0.84%, SD 1.64%; P<.001). CONCLUSIONS: This work highlights improvements in glycemic control that were clinically as well as statistically significant among Spanish-preferring adults enrolled in the Vida Health Spanish Diabetes Management Program. Greater improvements in glycemic control were observed among participants with higher program engagement. These results provide needed support for the use of digital health interventions to promote meaningful improvements in glycemic control in a medically underserved community.

2022 National Standards for Diabetes Self-Management Education and Support.

PURPOSE: The National Standards for Diabetes Self-Management Education and Support (DSMES) provide guidance and evidence-based, quality practice for all DSMES services. Due to the dynamic nature of health care and diabetes research, the National Standards are reviewed and revised approximately every 5 years by key stakeholders and experts within the diabetes care and education community. For each revision, the Task Force is charged with reviewing the current National Standards for appropriateness, relevance, and scientific basis and making updates based on current evidence and expert consensus. In 2021, the group was tasked with reducing administrative burden related to DSMES implementation across diverse care settings. CONCLUSION: The evidence supporting the 2022 National Standards clearly identifies the need to provide person-centered services that embrace cultural differences, social determinants of health, and the ever-increasing technological engagement platforms and systems. Payers are invited to review the National Standards as a tool to inform and modernize DSMES reimbursement requirements and to align with the evolving needs of people with diabetes (PWD) and physicians/other qualified health care professionals. The American Diabetes Association and the Association of Diabetes Care & Education Specialists strongly advocate for health equity to ensure all PWD have access to this critical service proven to improve outcomes both related to and beyond diabetes. The 2022 National Standards update is meant to be a universal document that is easy to understand and can be implemented by the entire health care community. DSMES teams in collaboration with primary care have been shown to be the most effective approach to overcome therapeutic inertia.

Improved Glycemic Control With a Digital Health Intervention in Adults With Type 2 Diabetes: Retrospective Study.

BACKGROUND: Traditional lifestyle interventions have shown limited success in improving diabetes-related outcomes. Digital interventions with continuously available support and personalized educational content may offer unique advantages for self-management and glycemic control. OBJECTIVE: In this study, we evaluated changes in glycemic control among participants with type 2 diabetes who enrolled in a digital diabetes management program. METHODS: The study employed a single-arm, retrospective design. A total of 950 participants with a hemoglobin A1c (HbA1c) baseline value of at least 7.0% enrolled in the Vida Health Diabetes Management Program. The intervention included one-to-one remote sessions with a Vida provider and structured lessons and tools related to diabetes management. HbA1c was the primary outcome measure. Of the 950 participants, 258 (27.2%) had a follow-up HbA1c completed at least 90 days from program start. Paired t tests were used to evaluate changes in HbA1c between baseline and follow-up. Additionally, a cluster-robust multiple regression analysis was employed to evaluate the relationship between high and low program usage and HbA1c change. A repeated measures analysis of variance was used to evaluate the difference in HbA1c as a function of the measurement period (ie, pre-Vida enrollment, baseline, and postenrollment follow-up). RESULTS: We observed a significant reduction in HbA1c of -0.81 points between baseline (mean 8.68, SD 1.7) and follow-up (mean 7.88, SD 1.46; t257=7.71; P<.001). Among participants considered high risk (baseline HbA1c≥8), there was an average reduction of -1.44 points between baseline (mean 9.73, SD 1.68) and follow-up (mean 8.29, SD 1.64; t139=9.14; P<.001). Additionally, average follow-up HbA1c (mean 7.82, SD 1.41) was significantly lower than pre-enrollment HbA1c (mean 8.12, SD 1.46; F2, 210=22.90; P<.001) There was also significant effect of program usage on HbA1c change (ß=-.60; P<.001) such that high usage was associated with a greater decrease in HbA1c (mean -1.02, SD 1.60) compared to low usage (mean -.61, SD 1.72). CONCLUSIONS: The present study revealed clinically meaningful improvements in glycemic control among participants enrolled in a digital diabetes management intervention. Higher program usage was associated with greater improvements in HbA1c. The findings of the present study suggest that a digital health intervention may represent an accessible, scalable, and effective solution to diabetes management and improved HbA1c. The study was limited by a nonrandomized, observational design and limited postenrollment follow-up data.

Experiments in engagement: Designing public engagement with science and technology for capacity building.

Public engagement with science and technology is now widely used in science policy and communication. Touted as a means of enhancing democratic discussion of science and technology, analysis of public engagement with science and technology has shown that it is often weakly tied to scientific governance. In this article, we suggest that the notion of capacity building might be a way of reframing the democratic potential of public engagement with science and technology activities. Drawing on literatures from public policy and administration, we outline how public engagement with science and technology might build citizen capacity, before using the notion of capacity building to develop five principles for the design of public engagement with science and technology. We demonstrate the use of these principles through a discussion of the development and realization of the pilot for a large-scale public engagement with science and technology activity, the Futurescape City Tours, which was carried out in Arizona in 2012.

Development of the Diabetes Technology Society Blood Glucose Monitor System Surveillance Protocol.

BACKGROUND: Inaccurate blood glucsoe monitoring systems (BGMSs) can lead to adverse health effects. The Diabetes Technology Society (DTS) Surveillance Program for cleared BGMSs is intended to protect people with diabetes from inaccurate, unreliable BGMS products that are currently on the market in the United States. The Surveillance Program will provide an independent assessment of the analytical performance of cleared BGMSs. METHODS: The DTS BGMS Surveillance Program Steering Committee included experts in glucose monitoring, surveillance testing, and regulatory science. Over one year, the committee engaged in meetings and teleconferences aiming to describe how to conduct BGMS surveillance studies in a scientifically sound manner that is in compliance with good clinical practice and all relevant regulations. RESULTS: A clinical surveillance protocol was created that contains performance targets and analytical accuracy-testing studies with marketed BGMS products conducted by qualified clinical and laboratory sites. This protocol entitled "Protocol for the Diabetes Technology Society Blood Glucose Monitor System Surveillance Program" is attached as supplementary material. CONCLUSION: This program is needed because currently once a BGMS product has been cleared for use by the FDA, no systematic postmarket Surveillance Program exists that can monitor analytical performance and detect potential problems. This protocol will allow identification of inaccurate and unreliable BGMSs currently available on the US market. The DTS Surveillance Program will provide BGMS manufacturers a benchmark to understand the postmarket analytical performance of their products. Furthermore, patients, health care professionals, payers, and regulatory agencies will be able to use the results of the study to make informed decisions to, respectively, select, prescribe, finance, and regulate BGMSs on the market.