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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

Standard

Exploring Decentralized Glucose and Behaviometric Monitoring of Persons with Type 2 Diabetes in the Setting of a Clinical Trial. / Ali, Zarqa; Valk, Teske Jacqueline; Bjerre-Christensen, Theis; Brandt, Sigurd; Isberg, Ari Pall; Jensen, Morten Lind; Helledi, Lise Sylvest; Kaas, Anne; Thomsen, Simon Francis; Andersen, Anders Daniel; Robert Zibert, John.

I: Journal of Diabetes Science and Technology, 2022, s. 1-8.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

Harvard

Ali, Z, Valk, TJ, Bjerre-Christensen, T, Brandt, S, Isberg, AP, Jensen, ML, Helledi, LS, Kaas, A, Thomsen, SF, Andersen, AD & Robert Zibert, J 2022, 'Exploring Decentralized Glucose and Behaviometric Monitoring of Persons with Type 2 Diabetes in the Setting of a Clinical Trial', Journal of Diabetes Science and Technology, s. 1-8. https://doi.org/10.1177/19322968211045656

APA

Ali, Z., Valk, T. J., Bjerre-Christensen, T., Brandt, S., Isberg, A. P., Jensen, M. L., Helledi, L. S., Kaas, A., Thomsen, S. F., Andersen, A. D., & Robert Zibert, J. (2022). Exploring Decentralized Glucose and Behaviometric Monitoring of Persons with Type 2 Diabetes in the Setting of a Clinical Trial. Journal of Diabetes Science and Technology, 1-8. https://doi.org/10.1177/19322968211045656

Vancouver

Ali Z, Valk TJ, Bjerre-Christensen T, Brandt S, Isberg AP, Jensen ML o.a. Exploring Decentralized Glucose and Behaviometric Monitoring of Persons with Type 2 Diabetes in the Setting of a Clinical Trial. Journal of Diabetes Science and Technology. 2022;1-8. https://doi.org/10.1177/19322968211045656

Author

Ali, Zarqa ; Valk, Teske Jacqueline ; Bjerre-Christensen, Theis ; Brandt, Sigurd ; Isberg, Ari Pall ; Jensen, Morten Lind ; Helledi, Lise Sylvest ; Kaas, Anne ; Thomsen, Simon Francis ; Andersen, Anders Daniel ; Robert Zibert, John. / Exploring Decentralized Glucose and Behaviometric Monitoring of Persons with Type 2 Diabetes in the Setting of a Clinical Trial. I: Journal of Diabetes Science and Technology. 2022 ; s. 1-8.

Bibtex

@article{9826d866915f4e73b19408cde61d88a0,
title = "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{\textquoteright} home address. The devices were connected to a study specific app on the participant{\textquoteright}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.",
keywords = "CGM, continuous glucose monitoring, DCT, decentralized clinical trial, diabetes, diabetes mellitus, remote, virtual",
author = "Zarqa Ali and Valk, {Teske Jacqueline} and Theis Bjerre-Christensen and Sigurd Brandt and Isberg, {Ari Pall} and Jensen, {Morten Lind} and Helledi, {Lise Sylvest} and Anne Kaas and Thomsen, {Simon Francis} and Andersen, {Anders Daniel} and {Robert Zibert}, John",
note = "Publisher Copyright: {\textcopyright} 2021 Diabetes Technology Society.",
year = "2022",
doi = "10.1177/19322968211045656",
language = "English",
pages = "1--8",
journal = "Journal of diabetes science and technology",
issn = "1932-2968",
publisher = "SAGE Publications",

}

RIS

TY - JOUR

T1 - Exploring Decentralized Glucose and Behaviometric Monitoring of Persons with Type 2 Diabetes in the Setting of a Clinical Trial

AU - Ali, Zarqa

AU - Valk, Teske Jacqueline

AU - Bjerre-Christensen, Theis

AU - Brandt, Sigurd

AU - Isberg, Ari Pall

AU - Jensen, Morten Lind

AU - Helledi, Lise Sylvest

AU - Kaas, Anne

AU - Thomsen, Simon Francis

AU - Andersen, Anders Daniel

AU - Robert Zibert, John

N1 - Publisher Copyright: © 2021 Diabetes Technology Society.

PY - 2022

Y1 - 2022

N2 - 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.

AB - 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.

KW - CGM

KW - continuous glucose monitoring

KW - DCT

KW - decentralized clinical trial

KW - diabetes

KW - diabetes mellitus

KW - remote

KW - virtual

UR - http://www.scopus.com/inward/record.url?scp=85115624662&partnerID=8YFLogxK

U2 - 10.1177/19322968211045656

DO - 10.1177/19322968211045656

M3 - Journal article

C2 - 34553637

AN - SCOPUS:85115624662

SP - 1

EP - 8

JO - Journal of diabetes science and technology

JF - Journal of diabetes science and technology

SN - 1932-2968

ER -

ID: 290459283