Evidence map›Paper›PMID 34553637›Full record

Trial reportJournal of diabetes science and technology2023

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

Zarqa Ali, Teske Jacqueline Valk, Theis Bjerre-Christensen, Sigurd Brandt, Ari Pall Isberg, Morten Lind Jensen, Lise Sylvest Helledi, Anne Kaas, Simon Francis Thomsen, Anders Daniel Andersen and 1 more

Open access · greenAbstract readClinical Trial
In one paragraph

Trial report in Journal of diabetes science and technology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Sample-size determination for decentralized clinical trials.International journal of epidemiology · 2025
    Article
  4. Article
  5. Review
  6. Review
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 1 country.

Zarqa AliDepartment of Dermatology and Venereology and Wound Healing Centre, Copenhagen University Hospital Bispebjerg, Denmark.ORCID 0000-0003-2411-7177
Teske Jacqueline ValkStudies&Me A/S, Copenhagen, Denmark.
Theis Bjerre-ChristensenStudies&Me A/S, Copenhagen, Denmark.
Sigurd BrandtStudies&Me A/S, Copenhagen, Denmark.
Ari Pall IsbergStudies&Me A/S, Copenhagen, Denmark.ORCID 0000-0002-7957-6285
Morten Lind JensenNovo Nordisk A/S, Bagsværd, Denmark.
Lise Sylvest HellediNovo Nordisk A/S, Bagsværd, Denmark.
Anne KaasNovo Nordisk A/S, Bagsværd, Denmark.
Simon Francis ThomsenDepartment of Dermatology and Venereology and Wound Healing Centre, Copenhagen University Hospital Bispebjerg, Denmark.
Anders Daniel AndersenStudies&Me A/S, Copenhagen, Denmark.
John Robert ZibertStudies&Me A/S, Copenhagen, Denmark.
University College Copenhagen · DKNovo Nordisk (Denmark) · DKBispebjerg Hospital · DKUniversity of Copenhagen · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClinical trials often suffer from recruitment barriers and poor adherence, which increases costs and affects trial outcomes.

objectiveTo investigate the feasibility of Decentralized Clinical Trial (DCT) design elements to recruit, enroll, and engage patients with type 2 diabetes mellitus (T2DM).

methodsPatients 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.

resultsTwenty-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%.

conclusionsUse of DCT design elements to conduct a T2DM study is feasible regarding recruitment, data collection from various electronic devices, and participant engagement.

Indexed as

Diabetes Mellitus, Type 2Blood GlucoseBlood Glucose Self-MonitoringGlucoseHumansSurveys and QuestionnairesBlood GlucoseGlucoseCGMcontinuous glucose monitoringDCTdecentralized clinical trialdiabetesdiabetes mellitusremotevirtual

Identifiers

PMID34553637
PMCPMC9846395
OpenAlexW3201406193

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.