Evidence map›Paper›PMID 39511648›Full record

ArticleTrials2024

The intelligent diabetes telemonitoring using decision support to treat patients on insulin therapy (DiaTRUST) trial: study protocol for a randomized controlled trial.

Camilla H N Thomsen, Jannie T D Nørlev, Stine Hangaard, Morten H Jensen, Ole Hejlesen, Sarah R Cohen, Allan Kofoed-Enevoldsen, Sika N S Kristensen, Tinna B Aradóttir, Anne Kaas and 2 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06185296 (The Intelligent Diabetes TelemonitoRing Using Decision Support to Treat Patients on Insulin Trial), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT06185296 narecruitingnot on this mapstarted 2025, after this paper: background citation

The Intelligent Diabetes TelemonitoRing Using Decision Support to Treat Patients on Insulin Trial: Study Protocol for a Randomized Controlled Trial

TypeinterventionalSponsorAalborg University HospitalRan2025 to 2026Enrolled51ConditionsType 2 Diabetes Treated With InsulinArmsIntelligent telemonitoring, Telemonitoring
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. 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

12 authors.

Camilla H N ThomsenSteno Diabetes Center North Denmark, Aalborg, 9000, Denmark. chnt@hst.aau.dk.
Jannie T D NørlevSteno Diabetes Center North Denmark, Aalborg, 9000, Denmark.
Stine HangaardSteno Diabetes Center North Denmark, Aalborg, 9000, Denmark.
Morten H JensenDepartment of Health Science and Technology, Aalborg University, Gistrup, 9260, Denmark.
Ole HejlesenDepartment of Health Science and Technology, Aalborg University, Gistrup, 9260, Denmark.
Sarah R CohenDepartment of Endocrinology, Zealand University Hospital - Nykøbing Falster, Nykøbing Falster, 4800, Denmark.
Allan Kofoed-EnevoldsenDepartment of Endocrinology, Zealand University Hospital - Nykøbing Falster, Nykøbing Falster, 4800, Denmark.
Sika N S KristensenCompanion SaMD Solutions, Novo Nordisk A/S, Bagsværd, 2880, Denmark.
Tinna B AradóttirCompanion SaMD Solutions, Novo Nordisk A/S, Bagsværd, 2880, Denmark.
Anne KaasMedical & Science, Devices and Digital Health, Novo Nordisk A/S, Bagsværd, 2880, Denmark.
Peter VestergaardSteno Diabetes Center North Denmark, Aalborg, 9000, Denmark.
Thomas KronborgSteno Diabetes Center North Denmark, Aalborg, 9000, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDiabetes affects 10.5% of adults globally, with type 2 diabetes accounting for 90-95% of cases. Achieving optimal glycemic control is crucial yet challenging, particularly with insulin therapy, where 30-50% of patients fail to meet treatment targets. Telemedicine can improve diabetes management but generates vast amounts of data, burdening healthcare professionals. Integrating clinical decision support tools into telemonitoring systems may enhance care efficiency and glycemic control.

methodsThe trial is a multicenter 3-month, three-arm, open-label, randomized controlled trial. The trial aims to enroll 51 participants with type 2 diabetes on insulin therapy. Participants will be divided with a 3:1:1 ratio into telemonitoring with decision support, telemonitoring without decision support, and usual care groups. The study employs connected insulin pens, continuous glucose monitors (CGMs), and activity trackers to enable telemonitoring. Outcomes measured include CGM time in range, HbA1c, hypo- and hyperglycemia incidents, total daily insulin dose, body weight, treatment satisfaction, and adherence. DISCUSSION: Telemonitoring with decision support has the potential to revolutionize diabetes management by offering personalized treatment suggestions, thereby reducing the burden on healthcare professionals, and improving patient outcomes. This study will provide valuable insights into the effectiveness of such an approach in achieving glycemic control in people with type 2 diabetes on insulin therapy. By evaluating both clinical outcomes and patient and healthcare professionals' satisfaction, the study aims to contribute to the development of efficient, scalable telehealth solutions for diabetes care.

trial registrationClinicalTrials.gov NCT06185296. Registered on December 14, 2023.

Indexed as

Blood GlucoseBlood Glucose Self-MonitoringDecision Support Systems, ClinicalDiabetes Mellitus, Type 2Glycemic ControlHypoglycemic AgentsInsulinMulticenter Studies as TopicRandomized Controlled Trials as TopicTelemedicineBiomarkersFitness TrackersGlycated HemoglobinHumansMiddle AgedTime FactorsBiomarkersBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulinClinical decision supportDiabetes careInsulin therapyTelemonitoringType 2 diabetes

Identifiers

PMID39511648
PMCPMC11545892

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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.