Diabetes mellitus is one of the most common metabolic disorders; it affects approximately 12.2% of the overall adult population in the United States and 25.25% of the population aged above 65 years [1]. One-third of the US adult population is affected by prediabetes. Diabetes can increase the overall risk of premature death and has been linked to several complications, including cardiovascular, renal, and neurological issues. Although diabetes is a major problem among all populations, people with disabilities are more prone to diabetes. According to the Behavioral Risk Factor Surveillance System 2017 report, nearly 1 in 4 people with disabilities are diagnosed with diabetes, whereas approximately 1 in 10 people without a disability are diagnosed with some form of diabetes [2].

Although physical disabilities increase the risk of developing diabetes, an inverse may also occur. Diabetes is associated with a significant increase in the risk of mobility disability [3]. It has been suggested that individuals with diabetes have an increased risk of disability because of multiple factors, such as obesity, depression, and stroke, when compared with individuals with no diabetes [4]. Similarly, numerous studies have indicated that diabetes may lead to disabling disorders, including cardiovascular disease [5], renal dysfunction [6], retinopathy [7,8], and peripheral vascular disease [8]. Older adults with diabetes are also less likely to engage in physical activity (PA) [9], and some are unable to perform minor physical tasks.

In diabetes management, PA, medication adherence, and glucose tracking have been shown to be effective in reducing glycated hemoglobin (HbA_1c) in both the general population and people with intellectual and developmental disabilities [10-15]. Recent meta-analyses have indicated that diabetes prevention and management programs emphasizing community engagement and tracking of food consumption, especially in the context of a low-carbohydrate diet, were more successful than medications in effective diabetes management [16,17]. Studies that investigated the effect of health promotion initiatives and lifestyle interventions on participants with disabilities also indicate that such efforts can promote healthy diets, regular exercise, and reduce sedentary lifestyle, thereby improving the management of chronic health conditions including obesity and diabetes among individuals with disabilities [15,18,19].

Diabetes education is essential for the treatment and management of diseases. Better education and knowledge can reduce the risk of developing diabetes complications while reducing morbidity and mortality. However, based on the 2014 Behavioral Risk Factor Surveillance System data, 47.3% of adults with disabilities did not receive diabetes education, and 10.86% did not visit health professionals for diabetes in the past year. This problem has been amplified by racial minorities. Low health literacy (LHL) is another major problem among people with disabilities [20,21]. Similarly, older adults, people with less than a high school degree, racial and ethnic minorities, people with low-income levels, and nonnative speakers of English are most likely to experience LHL [22]. Approximately 80 million adults in the United States are estimated to have LHL [23]. People with LHL are more prone to low diabetes knowledge levels [24-27] and limited glycemic control [26], resulting from unhealthy dietary habits, low PA levels, poor medication adherence, and poor blood glucose monitoring [23-27]. People with low literacy skills are not illiterate; however, using plain language is necessary to improve their health literacy and make written and oral information easier to understand [22]. Improving health literacy among participants with LHL would be beneficial for the education, treatment, and management of chronic diseases.

However, people with disabilities face inordinate barriers to achieving a healthy diet and recommended PA levels [28-31]. People with disabilities remain to be one of the least active populations in society [31-33]. Nationwide, 46% of people with disabilities have been categorized as physically inactive [32]. Maintaining a healthy diet is also a challenge for people with disabilities. There are several barriers to this process, such as feeling too tired to cook, organic or healthy, and nutrition foods being expensive, and lack of desire or willpower to cook [29]. All of these issues can be resolved using a systematic approach. However, accessible, inclusive, and adapted diabetes management programs for people with disabilities do not exist. Programs that are not designed with people with disabilities in mind (ie, noninclusive) pose various physical, programmatic, and attitudinal barriers. A few studies have examined diabetes management for people with disabilities, but they have all been singular studies that have not led to the creation of sustainable and scalable diabetes management programs for people with disabilities. For example, the National Center on Health, Physical Activity and Disability created the first Prevent T2 for ALL, an inclusive adaptation of the CDC’s Prevent T2 program. However, the Prevent T2 program is a diabetes prevention program (not a diabetes management program), and the primary focus is on BMI control, not glycemic control.

As our next step toward diabetes management for people with disabilities, we propose the development of an inclusive telecoaching self-management program for diabetes management in people with disabilities. To make the telecoaching approach sustainable and scalable, artificial intelligence techniques are employed to reduce the time health coaches spend on each participant.

The primary objective of this project is to evaluate the preliminary efficacy and feasibility of an accessible and inclusive artificial intelligence–assisted, individualized, family-focused lifestyle modification intervention (the Artificial Intelligence for Diabetes Management [AI4DM] intervention) for glycemic control in people with disabilities.

We hypothesize that the clinical outcome (HbA_1c) associated with type 2 diabetes mellitus (T2DM) self-management and self-efficacy outcomes would have a greater effect in the AI4DM intervention arm than in the attention control arm at the 3-, 6-, and 12-month follow-ups. We also hypothesize that the AI4DM intervention is feasible and acceptable for adults with permanent impaired mobility and T2DM, their caregivers, and health coaches and that the fidelity of the program will be maintained. A fidelity monitoring protocol was developed by the research team for the AI4DM study based on the five domains recommended by the National Institutes of Health Behavior Change Consortium [34].

The AI4DM study is a 2-arm randomized controlled trial. Eligible participants will be randomly assigned to one of two groups: (1) the AI4DM intervention group with telecoaching support and (2) the attention control group. The active intervention will include 6 months of telecoaching followed by 6 months of follow-up and access to the technology but with no telecoaching calls (Table 1). For the study, 4 weeks is considered a month, thereby making the study duration 48 weeks. Study activities involving participants with disabilities will be primarily conducted on the web nationally in the United States.

The AI4DM intervention is designed to evaluate the feasibility and preliminary efficacy of a web-based diabetes self-management program for people with disabilities. Participants will either be assigned to the intervention group, which includes telehealth coaching calls, a technology package, and access to diabetes educational content, or an attention control group, which will receive the same number of telecoaching calls at the same frequency as the intervention group. These calls generally serve as courtesy calls or general wellness calls.

Eligible participants must meet the following inclusion criteria: (1) a diagnosis of T2DM; (2) an HbA_1c level of ≥8%; (3) an age of 18-65 years; (4) individuals living with a permanent physical disability such as spinal cord injury, spina bifida, multiple sclerosis, or stroke and (5) the ability to speak and read English. To screen for permanently impaired mobility, the NHANES Physical Functioning Survey [35] will be used.

Exclusion criteria include (1) the use of insulin medication for diabetes treatment; (2) current enrollment in any diabetes-related intervention; (3) severe cognitive impairment; (4) severe untreated depression in the past 6 months; (5) a major cardiac event in the past 12 months; (6) uncontrolled blood pressure; (7) resting tachycardia; (8) renal failure; (9) severe peripheral neuropathy; and (10) the unavailability of a smartphone.

The total study duration for both groups is 12 months. The protocol includes both groups receiving weekly health coaching calls weekly for 12 weeks, and one biweekly coaching call (every other week) for 12 weeks, for a total of 18 coaching calls. The intervention group, AI4DM, will receive access to home and web-based technology and diabetes-specific educational content through a telehealth app. The attention control group will serve as an untreated comparison group for the AI4DM intervention group. Both groups will also receive 4 HbA_1c kits for glucose data collection.

After enrolling in the study, participants will automatically be emailed a Health Insurance Portability and Accountability Act (HIPAA)–compliant Research Electronic Data Capture (REDCap) link to a survey packet. REDCap is a secure program developed by a collaboration between Vanderbilt University and the National Institutes of Health National Center for Research Resources that manages and stores clinical trial data. This survey packet included a demographic survey and the secondary outcome measures listed in Table 2. Participants will be asked to complete this survey packet 4 times during the 12-month study period (excluding the demographics in the first survey packet). The timepoints included baseline, 3 months, 6 months, and postintervention (12 months).

After the first survey packet is emailed to the participants, a study team member will call the participants. The purpose of this call is to welcome them into the study and explain the study elements. During the call, the staff will inform the participant that they will receive a package within the next few days (see the section HbA_1c Kits).

All participants, regardless of study arm allocation, will receive 4 HbA_1c kits. The HbA_1c kits will be shipped from a clinical diagnostic laboratory testing company. Research personnel will have access to an account through the testing company website and will send an HbA_1c kit 4 times during the study duration: baseline (after the welcome call), 3 months, 6 months, and postintervention (12 months). The HbA_1c kit will include a testing kit and return packaging materials. Participants will be asked to complete and return the kit at their earliest convenience.

A randomization sequence will be generated and stored within REDCap, which automatically assigns a participant to the AI4DM intervention group or the attention control group. Randomization will only occur after the baseline survey packet and baseline HbA_1c kit are completed.

After randomization, a study health coach will be notified from REDCap that a participant has been randomized to one of the study arms and will conduct an orientation call with the participant. The purpose of this call is to introduce themselves to the participants as their primary health coach and to schedule the first weekly coaching call. The first weekly call, regardless of the study arm assignment, will be scheduled for the next calendar week.

If a participant is randomized into the AI4DM intervention group, the research staff will coordinate the shipment of a technology package that will be delivered to the participant’s residence within 1 to 2 days after randomization. The contents of this intervention package will include (1) an Amazon Echo, (2) a Fitbit Flex device, and (3) a wireless glucometer. Participants will also be given supplemental instructions for signing in to the mobile health (mHealth) app and device setup instructions. This package is used for intervention delivery and not for outcome measurements.

Coaching calls for the intervention group will be guided by a prepared outline of diabetes-related content that will be delivered to the participant through the mHealth app. This content will be delivered at the beginning of each week before the coaching call. The educational content is derived from using the Partnership to Improve Diabetes Education program and delivered to the participant as multimedia content [36]. Other health-related areas covered during the coaching call will include nutrition and eating habits, exercise and PA, glucose monitoring, and medication adherence. Questions outside the scope of the health coaching content will be provided to the study clinician or registered dietician. If the study team determines that the questions require collecting a participant’s detailed medical profile, the participant will be guided to communicate with their primary care physician. Finally, the health coach will address other health-related questions that the participant may have. For each call, the health coach will be able to record notes in the telehealth app regarding topics discussed with the participant for future calls, as needed. Coaching calls are expected to last for up to 60 minutes.

Biweekly coaching calls during the following 12 weeks will cover nutrition and eating habits, exercise and PA, glucose monitoring, medication adherence, general well-being, and Partnership to Improve Diabetes Education content, as needed.

The coaching content for the attention control group will refrain from any diabetes-specific content; rather, the health coach will only focus on general well-being. This will apply to all phone calls during weekly and biweekly coaching calls.

After the study duration, up to 30 participants from the AI4DM intervention group will be contacted for a follow-up interview to obtain their experiences and feedback with the AI4DM telehealth platform. These interviews will be conducted virtually.

Primary and secondary outcome measures will be assessed at baseline, 3 months, 6 months, and postintervention (12 months). The primary clinical outcome measure is HbA_1c with the secondary outcome measures described in Table 2.

This study will obtain measures related to the feasibility and acceptability of the AI4DM intervention on diabetes self-management. Measures will include process, resource, scientific, and management feasibility outcomes. All elements of intervention delivery will be collected, including but not limited to adherence, retention, attrition, coach and participant communication needs, staff preparation, and adverse events. Obtaining these measures will inform future considerations in the delivery of a web-based diabetes self-management program for people with disabilities.

The study duration for those enrolled in the study will be 12 months, regardless of study arm allocation.

A total of 90 participants will be enrolled. The sample size for this protocol is based on a primary analytic strategy of analysis of covariance, a two-sided test, type 1 error rate of 0.05, and intention-to-treat analysis with multiple imputations. Assuming a correlation between baseline and follow-up outcomes of at least 0.7, we will have 80% power to detect an effect size of 0.65.

The entire recruitment will be conducted on the web nationally through the National Center on Health, Physical Activity and Disability website and its associated social media. Through these mechanisms, interested individuals will be directed to a landing website page that will have promotional media content and information about the study. From there, participants will be directed to a separate link through HIPAA-compliant REDCap and complete a screening eligibility form. If deemed eligible, the participants will be sent an electronic consent form to be completed using the HIPAA-compliant REDCap. On the basis of our recruitment methods, we expect that approximately 180 individuals will be screened for eligibility.

Participants will be randomized to the two study arms in a 1:1 allocation ratio using a computer-generated randomization procedure. The allocation sequence will be implemented after the baseline surveys, and the baseline HbA_1c kit has been completed by the participant. The computer-generated randomization process will be implemented in REDCap after the data from the baseline surveys and HbA_1c kit are entered into the REDCap database. This will trigger the allocation procedure to randomly assign participants to one of the two study arms. The health coach will be notified about the randomization through the telecoaching dashboard and will inform the participants about their randomization into the AI4DM intervention or the attention control arm during the orientation call.

The principal investigator and primary statistician will be blinded to the randomization of the participants into the study arms. All other study staff will be unblinded for purposes of recruitment, consent, orientation calls, welcome calls, coaching calls, and intervention package shipping. There are no circumstances in which the principal investigator or statistician will become unblinded during this protocol.

All data collected will be entered directly into REDCap. Participants will be assigned a subject number upon enrollment in the study. Only approved study personnel will have access to the REDCap program, where data will be stored. Data checking will involve confirming that surveys, questionnaires, and HbA_1c values are completed.

All data will be examined for normality violations, outliers, errors, and patterns of missing values. For primary and secondary outcome measures, the sample and variables will be described using frequency distributions and appropriate summary statistics. Randomization across the study arms will be checked. If any baseline variable differs by group, it will be included as a covariate in subsequent analyses. Our primary analysis for the hypothesis that adults in the AI4DM intervention group will result in better glycemic control than the attention control group will be tested using analysis of covariance with baseline measurement as a covariate. Multiple imputations will be used to impute missing data. The study data will also explore the pattern and missing mechanism, and additional sensitivity analyses will be performed to test parametric assumptions as well as assumptions of missingness. Outliers and normality of quantitative variables will be evaluated. This study is powered to enable the estimation of effect sizes. Analysis of the clinical outcome (HbA_1c) will control for the impact of medication and dosage during the intervention period.

This project is a pilot feasibility and efficacy study that has duration of 12 months and only has minimal risks. Therefore, we believe that a data monitoring committee is not required. The principal investigator will be responsible for protocol fidelity and data collection throughout the study. The biostatistician will oversee data analysis in preparation for publication.

The AI4DM study will monitor all adverse events. Adverse events will be assessed for severity and causality and will be reported to the institutional review board and all other relevant regulatory bodies as needed.

All elements of the study protocol will be evaluated at regular intervals (ie, weekly, monthly, or quarterly) to ensure proper and consistent adherence to the study design and implementation. Elements of auditing will include checklists, coaching call logs, audio recordings or coaching calls, content resource banks, telehealth platform reviews and event logs, review of participant food, PA, medication, glucose entries, time spent on the platform, and team meetings to discuss participant progress and protocol adherence.

All proposed elements of this protocol will be approved by the university’s institutional review board before beginning the study.

Any changes deemed necessary by the principal investigator will be submitted as amendments to the university’s institutional review board and will only make changes after approval.

All consent processes will be conducted on the web through predetermined screening questionnaires provided through the landing website and REDCap link. If a participant is deemed eligible through the web-based process, an electronic consent form will be sent to the participant to complete. Only approved study staff will have access to complete records of the consent form.

Personal information will be collected in this study. All personal information shared, such as demographic details, will be collected and stored through HIPAA-compliant REDCap. Only approved study staff will have access to securely stored personal information. All information will be subject to the university’s institutional review board and the policies of affiliated entities surrounding confidentiality.

There are no declarations of interests for all study staff for this protocol.

This is not applicable. No provisions for posttrial care are included in the study.

The results of this study will be disseminated publicly through publications in peer-reviewed journals and presented at regional and national conferences.

Blood samples will be collected for HbA_1c analysis at 4 different time points (baseline, 3-month, 6-month, and 12-month). The laboratory testing service will be responsible for mailing, receiving, and processing completed HbA_1c kits. The study personnel will not interact or have access to blood samples at the testing laboratory.