Exploring Decentralized Glucose and Behaviometric Monitoring of Persons with Type 2 Diabetes in the Setting of a Clinical Trial

Abstract

Background: Clinical trials often suffer from recruitment barriers and poor adherence, which increases costs and affects trial outcomes. Objective: To investigate the feasibility of Decentralized Clinical Trial (DCT) design elements to recruit, enroll, and engage patients with type 2 diabetes mellitus (T2DM). Methods: Patients with T2DM were recruited through a pharmacy and online recruitment using advert on Facebook, to 3 weeks monitoring of glucose and behaviometric parameters. Subjects recruited online could either complete an informed consent conversation in the pharmacy or through live video call managed by the study app. A continuous glucose monitoring (CGM) device to collect glucose data, and a hybrid smartwatch to monitor heart rate, track activity and sleep pattern were delivered by postal service to the participants’ home address. The devices were connected to a study specific app on the participant’s smartphone also capturing GPS data and questionnaire answers. Results: Twenty-six subjects (3 pharmacy, 23 online) with T2DM were recruited, 85% preferred online informed consent conversation. All participants were able to self-apply the CGM device, use the smartwatch, and download the app. GPS location was captured more than 100 times for each participant, and more than 90% completed all 3 questionnaires. All the participants felt safe with the informed consent process and they felt confident in participating from home. Three participants dropped-out during the study period leaving a retention rate at 87%. Conclusions: Use of DCT design elements to conduct a T2DM study is feasible regarding recruitment, data collection from various electronic devices, and participant engagement.

Feasibility study for a fully decentralized clinical trial in participants with functional constipation symptoms

“…The considerations comprehensively support the DCT design, as it enables study monitoring with little cost and can reflect real‐world clinical practices. In the same vein, DCT approaches have been observed in trials for atrial fibrillation, 12 Parkinson's disease, 29 and type 2 diabetes, 30 all of which satisfy the aforementioned features. The efficacy results in our study were comparable to those in the traditional clinical trial, suggesting the feasibility of a DCT design in functional constipation.…”

Methods and perceptions of success for patient recruitment in decentralized clinical studies

“…Participant recruitment is one of the largest barriers to successful clinical trials, and the included articles demonstrate that investigators are willing to implement decentralized methods to access potential participants through nontraditional means [1]. The studies identified in this review reported faster recruitment rates and higher amounts of enrolled participants through conducting the enrollment process virtually or by using social media advertisements [18][19][20][21][22][23][24][25][26][27][28][29]. The strongest evidence comes from the trials that have conducted recruitment through virtual and traditional methods, comparing the outcomes between the two [18][19][20][21]23,24,28,29].…”

“…The studies identified in this review reported faster recruitment rates and higher amounts of enrolled participants through conducting the enrollment process virtually or by using social media advertisements [18][19][20][21][22][23][24][25][26][27][28][29]. The strongest evidence comes from the trials that have conducted recruitment through virtual and traditional methods, comparing the outcomes between the two [18][19][20][21]23,24,28,29]. In addition, presenting patients with the opportunity to enroll in clinical trials implementing decentralized methods has also been shown to increase self-reported likelihood to enroll [17].…”

Insights into Non-Exercise Physical Activity on Control of Body Mass: A Review with Practical Recommendations

“…The Michigan Predictive Activity & Clinical Trajectories in Health (MIPACT) study is a good example of how data collected from wearable devices can inform clinical trial design, interpretation in clinical practice, and health-care interventions [ 72 ]. Wearable devices represent an important element that offers new opportunities for conducting decentralized clinical trials [ 73 ], which have been shown to be effective and feasible regarding recruitment, data collection from various electronic devices, and participant engagement to monitor physiological and behaviometric (physical activity and sleep patterns) parameters [ 74 ]. For practical purposes, Table 2 summarizes some characteristics of commercially available accelerometer-based wearable devices, many of which are used in research for physical activity quantification.…”