Exploring Decentralized Glucose and Behaviometric Monitoring of Persons with Type 2 Diabetes in the Setting of a Clinical Trial
| Autor: | Teske Jacqueline Valk, Sigurd Brandt, Lise Sylvest Helledi, Zarqa Ali, Anders Daniel Andersen, Simon Francis Thomsen, Anne Kaas, Theis Bjerre-Christensen, Ari Pall Isberg, Morten Lind Jensen, John Robert Zibert |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Continuous glucose monitoring business.industry Endocrinology Diabetes and Metabolism Biomedical Engineering Bioengineering Type 2 diabetes Original Articles medicine.disease Clinical trial Poor adherence Diabetes mellitus Internal Medicine Medicine business Intensive care medicine |
| Zdroj: | J Diabetes Sci Technol |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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