PMID- 34553637
OWN - NLM
STAT- MEDLINE
DCOM- 20230104
LR  - 20230222
IS  - 1932-2968 (Electronic)
IS  - 1932-2968 (Linking)
VI  - 17
IP  - 1
DP  - 2023 Jan
TI  - Exploring Decentralized Glucose and Behaviometric Monitoring of Persons with Type 
      2 Diabetes in the Setting of a Clinical Trial.
PG  - 117-124
LID - 10.1177/19322968211045656 [doi]
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.
FAU - Ali, Zarqa
AU  - Ali Z
AUID- ORCID: 0000-0003-2411-7177
AD  - Department of Dermatology and Venereology and Wound Healing Centre, Copenhagen 
      University Hospital Bispebjerg, Denmark.
FAU - Valk, Teske Jacqueline
AU  - Valk TJ
AD  - Studies&Me A/S, Copenhagen, Denmark.
FAU - Bjerre-Christensen, Theis
AU  - Bjerre-Christensen T
AD  - Studies&Me A/S, Copenhagen, Denmark.
FAU - Brandt, Sigurd
AU  - Brandt S
AD  - Studies&Me A/S, Copenhagen, Denmark.
FAU - Isberg, Ari Pall
AU  - Isberg AP
AUID- ORCID: 0000-0002-7957-6285
AD  - Studies&Me A/S, Copenhagen, Denmark.
FAU - Jensen, Morten Lind
AU  - Jensen ML
AD  - Novo Nordisk A/S, Bagsvaerd, Denmark.
FAU - Helledi, Lise Sylvest
AU  - Helledi LS
AD  - Novo Nordisk A/S, Bagsvaerd, Denmark.
FAU - Kaas, Anne
AU  - Kaas A
AD  - Novo Nordisk A/S, Bagsvaerd, Denmark.
FAU - Thomsen, Simon Francis
AU  - Thomsen SF
AD  - Department of Dermatology and Venereology and Wound Healing Centre, Copenhagen 
      University Hospital Bispebjerg, Denmark.
AD  - Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.
FAU - Andersen, Anders Daniel
AU  - Andersen AD
AD  - Studies&Me A/S, Copenhagen, Denmark.
FAU - Robert Zibert, John
AU  - Robert Zibert J
AD  - Studies&Me A/S, Copenhagen, Denmark.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20210923
PL  - United States
TA  - J Diabetes Sci Technol
JT  - Journal of diabetes science and technology
JID - 101306166
RN  - 0 (Blood Glucose)
RN  - IY9XDZ35W2 (Glucose)
SB  - IM
MH  - Humans
MH  - Blood Glucose
MH  - Blood Glucose Self-Monitoring
MH  - *Diabetes Mellitus, Type 2
MH  - Glucose
MH  - Surveys and Questionnaires
PMC - PMC9846395
OTO - NOTNLM
OT  - CGM
OT  - DCT
OT  - continuous glucose monitoring
OT  - decentralized clinical trial
OT  - diabetes
OT  - diabetes mellitus
OT  - remote
OT  - virtual
COIS- The author(s) declared the following potential conflicts of interest with respect 
      to the research, authorship, and/or publication of this article: Zarqa Ali, Simon 
      Francis Thomsen: None related to this project Teske Jacqueline Valk, Theis 
      Bjerre-Christensen, Sigurd Brandt, Ari Pall Isberg, Anders Daniel Andersen, John 
      Robert Zibert: Studies&Me employee. Morten Lind Jensen, Lise Sylvest Helledi, 
      Anne Kaas: Novo Nordisk employees and shareholders.
EDAT- 2021/09/24 06:00
MHDA- 2023/01/04 06:00
PMCR- 2022/09/23
CRDT- 2021/09/23 08:40
PHST- 2021/09/24 06:00 [pubmed]
PHST- 2023/01/04 06:00 [medline]
PHST- 2021/09/23 08:40 [entrez]
PHST- 2022/09/23 00:00 [pmc-release]
AID - 10.1177_19322968211045656 [pii]
AID - 10.1177/19322968211045656 [doi]
PST - ppublish
SO  - J Diabetes Sci Technol. 2023 Jan;17(1):117-124. doi: 10.1177/19322968211045656. 
      Epub 2021 Sep 23.