Evidence map›Paper›PMID 38778345›Full record

ArticlePilot and feasibility studies2024

A telemonitoring intervention design for patients with poorly controlled type 2 diabetes: protocol for a feasibility study.

Sisse H Laursen, Iben Engelbrecht Giese, Flemming W Udsen, Ole K Hejlesen, Pernille F Barington, Morten Ohrt, Peter Vestergaard, Stine Hangaard

Registry-linked trialAbstract read
In one paragraph

Article in Pilot and feasibility studies, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06134934 (TeleCare North Diabetes), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

NCT06134934 naactive not recruitingnot on this map

TeleCare North Diabetes: A Feasibility Study

TypeinterventionalSponsorAalborg University HospitalRan2024 to 2026Enrolled60ConditionsDiabetes Mellitus, Type 2ArmsTelemonitoring 1, Telemonitoring 2
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

8 authors.

Sisse H LaursenSteno Diabetes Center North Denmark, Aalborg University Hospital, Aalborg, Denmark. sih@hst.aau.dk.ORCID http://orcid.org/0000-0001-5884-8125
Iben Engelbrecht GieseDepartment of Health Science and Technology, Aalborg University, Gistrup, Denmark.
Flemming W UdsenDepartment of Health Science and Technology, Aalborg University, Gistrup, Denmark.
Ole K HejlesenDepartment of Health Science and Technology, Aalborg University, Gistrup, Denmark.
Pernille F BaringtonSteno Diabetes Center North Denmark, Aalborg University Hospital, Aalborg, Denmark.
Morten OhrtNord-KAP, The Quality Unit for General Practice in the North Denmark Region, Aalborg, Denmark.
Peter VestergaardSteno Diabetes Center North Denmark, Aalborg University Hospital, Aalborg, Denmark.
Stine HangaardSteno Diabetes Center North Denmark, Aalborg University Hospital, Aalborg, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMaintaining optimal glycemic control in type 2 diabetes (T2D) is difficult. Telemedicine has the potential to support people with poorly regulated T2D in the achievement of glycemic control, especially if the telemedicine solution includes a telemonitoring component. However, the ideal telemonitoring design for people with T2D remains unclear. Therefore, the aim of this feasibility study is to evaluate the feasibility of two telemonitoring designs for people with non-insulin-dependent T2D with a goal of identifying the optimal telemonitoring intervention for a planned future large-scale randomized controlled trial.

methodThis 3-month randomized feasibility study will be conducted in four municipalities in North Denmark starting in January 2024. There will be 15 participants from each municipality. Two different telemonitoring intervention designs will be tested. One intervention will include self-monitoring of blood glucose (SMBG) combined with sleep and mental health monitoring. The second intervention will include an identical setup but with the addition of blood pressure and activity monitoring. Two municipalities will be allocated to one intervention design, whereas the other two municipalities will be allocated to the second intervention design. Qualitative interviews with participants and clinicians will be conducted to gain insight into their experiences with and acceptance of the intervention designs and trial procedures (e.g., blood sampling and questionnaires). In addition, sources of differences in direct intervention costs between the two alternative interventions will be investigated. DISCUSSION: Telemonitoring has the potential to support people with diabetes in achieving glycemic control, but the existing evidence is inconsistent, and thus, the optimal design of interventions remains unclear. The results of this feasibility study are expected to produce relevant information about telemonitoring designs for people with T2D and help guide the design of future studies. A well-tested telemonitoring design is essential to ensure the quality of telemedicine initiatives, with goals of user acceptance and improved patient outcomes.

trial registrationClinicalTrials.gov, ID: NCT06134934 . Registered November 1, 2023. The feasibility trial has been approved (N-20230026) by the North Denmark Region Committee on Health Research Ethics (June 5, 2023).

Indexed as

Blood glucoseDiabetes mellitusFeasibilityTelehealthTelemedicineTelemonitoringType 2

Identifiers

PMID38778345
PMCPMC11110324

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Registered trials

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.