Evidence map›Paper›PMID 39049109›Full record

ArticleTrials2024

A deprescribing programme aimed to optimise blood glucose-lowering medication in older people with type 2 diabetes mellitus, the OMED2-study: the study protocol for a randomised controlled trial.

Charlotte Andriessen, Marieke T Blom, Beryl A C E van Hoek, Anna W de Boer, Petra Denig, G Ardine de Wit, Karin Swart, Angela de Rooij-Peek, Rob J van Marum, Jacqueline G Hugtenburg and 7 more

Abstract 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. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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.

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

6 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Use of Fixed Ratio Combinations to Improve Glycemic Control in Individuals with Type 2 Diabetes: Experts' Opinion from the Gulf Region.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2026
    Review
  6. 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

17 authors.

Charlotte AndriessenDepartment of General Practice, Amsterdam UMC, Location Vrije Universiteit, Meibergdreef 15, Amsterdam, 1105AZ, the Netherlands.
Marieke T BlomDepartment of General Practice, Amsterdam UMC, Location Vrije Universiteit, Meibergdreef 15, Amsterdam, 1105AZ, the Netherlands.
Beryl A C E van HoekDepartment of General Practice, Amsterdam UMC, Location Vrije Universiteit, Meibergdreef 15, Amsterdam, 1105AZ, the Netherlands.
Anna W de BoerDepartment of Public Health and Primary Care / Health Campus The Hague, LUMC, Leiden, The Netherlands.
Petra DenigDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.
G Ardine de WitDepartment of Health Sciences, Faculty of Beta Sciences, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.
Karin SwartPHARMO Institute for Drug Outcomes Studies, Utrecht, The Netherlands.
Angela de Rooij-PeekDiabetesvereniging Nederland, Leusden, Netherlands.
Rob J van MarumDepartment of Geriatric Medicine, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.
Jacqueline G HugtenburgDepartment of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.
Pauline SlottjeDepartment of General Practice, Amsterdam UMC, Location Vrije Universiteit, Meibergdreef 15, Amsterdam, 1105AZ, the Netherlands.
Daniël van RaalteDiabetes Center, Department of Internal Medicine, Amsterdam University Medical Center, Amsterdam, Netherlands.
Liselotte van BloemendaalDepartment of Internal Medicine - Geriatrics, Amsterdam University Medical Center, Amsterdam, Netherlands.
Ron HeringsPHARMO Institute for Drug Outcomes Studies, Utrecht, The Netherlands.
Giel NijpelsDepartment of General Practice, Amsterdam UMC, Location Vrije Universiteit, Meibergdreef 15, Amsterdam, 1105AZ, the Netherlands.
Rimke C VosDepartment of Public Health and Primary Care / Health Campus The Hague, LUMC, Leiden, The Netherlands.
Petra J M EldersDepartment of General Practice, Amsterdam UMC, Location Vrije Universiteit, Meibergdreef 15, Amsterdam, 1105AZ, the Netherlands. p.elders@amsterdamumc.nl.ORCID http://orcid.org/0000-0002-5907-7219

Funding

ZonMw 848018102
6 · The paper itself

Abstract

backgroundOlder patients with type 2 diabetes mellitus (T2D) have an increased risk of hypoglycaemic episodes when using sulphonylureas or insulin. In the Netherlands, guidelines exist for reducing glucose-lowering medication in older patients. However, evidence is lacking that a medication reduction in older patients can be safely pursued. Here, we will examine if promoting the deprescribing of insulin/sulphonylureas with a deprescribing programme (DPP) in general practice affects T2D-complications in older overtreated patients.

methodsWe will perform a 1:1 cluster randomised controlled trial in 86 general practices in the Netherlands. The DPP will consist of education sessions with general practitioners and practice nurses about reducing glucose-lowering medication in older patients (≥ 70 years). Topics of the sessions include the necessity of deprescribing, tools to initiate deprescribing and strategies to discuss deprescribing with patients (shared decision making). The DPP further includes a support programme with practice visits. The study will employ a selection tool to identify possibly overtreated older patients from the electronic medical records of the general practitioner. Eligibility for enrolment in the study will be based on HbA1c targets indicated by the Dutch guidelines, which depend on age, diabetes duration, presence of frailty, and life expectancy. The control group will provide usual care. We aim to include 406 patients. The follow-up period will be 2 years. For the primary outcome, the effect of the DPP on T2D-complications will be assessed by counting the cumulative incidence of events related to under- and overtreatment in T2D as registered in the electronic medical records. We shall perform an intention-to-treat analysis and an analysis including only patients for whom deprescribing was initiated. The implementation of the DPP in general practice will be evaluated quantitatively and qualitatively using the Extended Normalisation Process Theory (ENPT) and the Reach, Efficacy - Adoption, Implementation and Maintenance (RE-AIM) model. Other secondary outcomes include quality of life, cognitive functioning, events related to overtreatment or undertreatment, biomarkers of health, amount of blood glucose-lowering medication prescriptions, and cost-effectiveness. DISCUSSION: This study will provide insight into the safety and feasibility of a programme aimed at deprescribing sulphonylureas/insulin in older people with T2D who are treated in general practice.

trial registrationISRCTN Registry, ISRCTN50008265 , registered 09 March, 2023.

Indexed as

Blood GlucoseDeprescriptionsDiabetes Mellitus, Type 2Glycemic ControlHypoglycemic AgentsRandomized Controlled Trials as TopicSulfonylurea CompoundsAgedAge FactorsBiomarkersGlycated HemoglobinHumansHypoglycemiaInsulinMulticenter Studies as TopicNetherlandsBiomarkersBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulinSulfonylurea CompoundsElderlyExtended normalisation process theoryGeneral practitionersHypoglycaemiaOvertreatmentType 2 diabetes

Identifiers

PMID39049109
PMCPMC11271055

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.