Evidence map›Paper›PMID 41214519›Full record

Trial reportBMC primary care2025

Cost-effectiveness of a periodic fasting-mimicking diet programme in patients with type 2 diabetes: a trial-based analysis and a lifetime model-based analysis.

Elske L van den Burg, Petra G van Peet, Marjolein P Schoonakker, Ayla C Esmeijer, Hildo J Lamb, Mattijs E Numans, Hanno Pijl, M Elske van den Akker-van Marle

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC primary care, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03811587 (Clinical Feasibility and Efficacy of Intermittent Use of a Fasting Mimicking Diet in the Treatment of Type 2 Diabetes), 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.

NCT03811587 nacompletednot on this map

Clinical Feasibility and Efficacy of Intermittent Use of a Fasting Mimicking Diet in the Treatment of Type 2 Diabetes

TypeinterventionalSponsorLeiden University Medical CenterRan2018 to 2021Enrolled100ConditionsDiabetes Mellitus, Type 2ArmsFasting Mimicking diet
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Review
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.

Elske L van den BurgDepartment of Public Health and Primary Care, Leiden University Medical Centre (LUMC), Post Zone V0-P, Postbus 9600, 2300 RC, Leiden, The Netherlands. e.l.van_den_burg@lumc.nl.
Petra G van PeetDepartment of Public Health and Primary Care, Leiden University Medical Centre (LUMC), Post Zone V0-P, Postbus 9600, 2300 RC, Leiden, The Netherlands.
Marjolein P SchoonakkerDepartment of Public Health and Primary Care, Leiden University Medical Centre (LUMC), Post Zone V0-P, Postbus 9600, 2300 RC, Leiden, The Netherlands.
Ayla C EsmeijerDepartment of Public Health and Primary Care, Leiden University Medical Centre (LUMC), Post Zone V0-P, Postbus 9600, 2300 RC, Leiden, The Netherlands.
Hildo J LambDepartment of Radiology, Leiden University Medical Centre (LUMC), Leiden, The Netherlands.
Mattijs E NumansDepartment of Public Health and Primary Care, Leiden University Medical Centre (LUMC), Post Zone V0-P, Postbus 9600, 2300 RC, Leiden, The Netherlands.
Hanno PijlDepartment of Public Health and Primary Care, Leiden University Medical Centre (LUMC), Post Zone V0-P, Postbus 9600, 2300 RC, Leiden, The Netherlands.
M Elske van den Akker-van MarleDepartment of Biomedical Data Sciences, Medical Decision Making, Leiden University Medical Centre (LUMC), Leiden, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe prevalence of type 2 diabetes continues to rise worldwide, which is associated with a decrease in quality of Life and an increase in healthcare costs. The aim of this study was to determine cost-effectiveness of a one year monthly 5-consecutive day fasting-mimicking diet (FMD) programme for patients with type 2 diabetes treated with lifestyle advice only or lifestyle advice plus metformin, compared to usual care.

methodsA trial-based cost-utility analysis with quality-adjusted life-years (QALYs) and healthcare costs was performed. These results were extrapolated to a lifetime horizon using the United Kingdom Prospective Diabetes Study Outcomes Model, predicting cardiovascular events and mortality. Cost-effectiveness acceptability curves were assessed, representing the probability of the FMD programme being cost-effective compared to usual care across a range of willingness-to-pay (WTP) thresholds per QALY.

resultsIn the trial-based analysis (n = 92), QALYs were insignificantly lower (-0.04, 95% CI -0.10 to + 0.03), while healthcare costs were significantly higher (+ €2241, 95% CI + 182 to + 2660) in the FMD group. In contrast, from a lifetime horizon, QALYs were insignificantly higher in the FMD group (+ 0.16, 95% CI -1.16 to + 1.48) and costs were insignificantly higher as well (+ €1336, 95% CI -753 to + 3425), yielding an incremental cost-effectiveness ratio of €8369/QALY. Thus, in the lifetime analysis the probability of cost-effectiveness of the FMD programme was around 0.6 as compared to usual care at most WTP thresholds.

conclusionsThe FMD programme does not appear to be cost-effective over the first year of its application in the context of the Dutch healthcare system. However, this conclusion should be interpreted with caution due to the small sample size. In the extrapolations of the lifetime model-based cost-effectiveness analysis, a gain in QALYs in the FMD group was seen and the FMD programme’ costs were largely offset by savings in the costs of diabetic complications. This suggests that adding an FMD programme to usual care may potentially be cost-effective in the long term.

trial registrationClinicalTrials.gov: NCT03811587. Registered 22 January 2019.

Indexed as

Diabetes Mellitus, Type 2FastingAgedCost-Benefit AnalysisCost-Effectiveness AnalysisFemaleHealth Care CostsHumansHypoglycemic AgentsIntermittent FastingLife StyleMaleMetforminMiddle AgedQuality-Adjusted Life YearsHypoglycemic AgentsMetforminCost-effectivenessDietFasting-mimicking dietPrimary careTherapyType 2 diabetes

Identifiers

PMID41214519
PMCPMC12599020

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC-ND
Read underepoch 390

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 Socratic graph.