Exploring Decentralized Glucose and Behaviometric Monitoring of Persons with Type 2 Diabetes in the Setting of a Clinical Trial
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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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, Bind 17, Nr. 1, 2023, s. 117-124.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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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 - 2023
Y1 - 2023
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
VL - 17
SP - 117
EP - 124
JO - Journal of diabetes science and technology
JF - Journal of diabetes science and technology
SN - 1932-2968
IS - 1
ER -
ID: 290459283