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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

  • Zarqa Ali
  • Teske Jacqueline Valk
  • Theis Bjerre-Christensen
  • Sigurd Brandt
  • Ari Pall Isberg
  • Morten Lind Jensen
  • Lise Sylvest Helledi
  • Anne Kaas
  • Thomsen, Simon Francis
  • Anders Daniel Andersen
  • John Robert Zibert

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.

OriginalsprogEngelsk
TidsskriftJournal of Diabetes Science and Technology
Sider (fra-til)1-8
ISSN1932-2968
DOI
StatusE-pub ahead of print - 2022

Bibliografisk note

Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was funded by Studies&Me

Publisher Copyright:
© 2021 Diabetes Technology Society.

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