Evidence map›Paper›PMID 41316005›Full record

Trial reportBMC geriatrics2025

Protocol: a Comprehensive Approach to Reduce Elderly functional decline in Diabetes: the CARED study.

Alice Margherita Ornago, Francesca Remelli, Caterina Trevisan, Alberto Finazzi, Eugenia Casali, Diego Mastino, Efisio Cossu, Giovanna Manconi, Carla Serra, Alessandro Sestu and 5 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in BMC geriatrics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06842459 (Prevention of Functional Decline by Multimodal Intervention in Older Patients With Diabetes), which is not on this map. Not yet cited in PubMed.

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

NCT06842459 narecruitingnot on this map

Prevention of Functional Decline by Multimodal Intervention in Older Patients With Diabetes

TypeinterventionalSponsorUniversity of CagliariRan2025 to 2026Enrolled180ConditionsDiabetes, Older PeopleArmsGeriatric Assessment
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

15 authors.

Alice Margherita OrnagoSchool of Medicine and Surgery, University of Milano-Bicocca, Piazza dell'Ateneo Nuovo 1, Milan, Italy. aliceornago93@gmail.com.ORCID http://orcid.org/0009-0008-7927-793X
Francesca RemelliDepartment of Medical Sciences, University of Ferrara, Ferrara, Italy.
Caterina TrevisanDepartment of Medical Sciences, University of Ferrara, Ferrara, Italy.
Alberto FinazziSchool of Medicine and Surgery, University of Milano-Bicocca, Piazza dell'Ateneo Nuovo 1, Milan, Italy.
Eugenia CasaliSchool of Medicine and Surgery, University of Milano-Bicocca, Piazza dell'Ateneo Nuovo 1, Milan, Italy.
Diego MastinoDiabetes Unit, Policlinico di Cagliari, Cagliari, Italy.
Efisio CossuDiabetes Unit, Policlinico di Cagliari, Cagliari, Italy.
Giovanna ManconiInternal Medicine Unit, Policlinico di Cagliari, Cagliari, Italy.
Carla SerraInternal Medicine Unit, Policlinico di Cagliari, Cagliari, Italy.
Alessandro SestuDepartment of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.
Gianluca PerseghinSchool of Medicine and Surgery, University of Milano-Bicocca, Piazza dell'Ateneo Nuovo 1, Milan, Italy.
Marcello MonesiTerritorial Diabetes Unit, AUSL of Ferrara, Ferrara, Italy.
Stefano VolpatoDepartment of Medical Sciences, University of Ferrara, Ferrara, Italy.
Giuseppe BellelliSchool of Medicine and Surgery, University of Milano-Bicocca, Piazza dell'Ateneo Nuovo 1, Milan, Italy.
Angelo ScuteriInternal Medicine Unit, Policlinico di Cagliari, Cagliari, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundType 2 diabetes mellitus (T2DM) is a common chronic disease in older adults and a leading cause of death and disability worldwide. While recent diabetes guidelines introduce the Comprehensive Geriatric Assessment (CGA) as a key tool for managing diabetes treatments, evidence of its effectiveness in delaying functional impairment and achieving patient-reported outcomes (PROs) remains lacking. This article describes the protocol of a randomized parallel-group controlled trial aimed at evaluating the effect of a CGA-guided plan of care on physical performance changes over time as compared with a usual-care group.

methodsThree centers will participate in this study, each recruiting 60 older adults with T2DM from their outpatient clinics. Eligible patients will be randomized into either the usual-care or intervention group in a 1:1 allocation ratio. All patients will receive standard care according to current diabetes guidelines and undergo CGA. For the intervention group, the CGA will guide a multidimensional intervention. Follow-up visits will be scheduled at 6 and 12 months. The primary outcome will be the change in physical performance at the end of the follow-up, as assessed by the Short Physical Performance Battery score, with a comparison between the control and intervention groups. DISCUSSION: From this study, we will contribute to the growing evidence of the impact of CGA on the assessment and management of older patients with T2DM and its complications. Results will be disseminated through a peer-reviewed journal and presentations at conferences. Final results will be shared with a broader audience through collaborations with patients with diabetes and their caregiver association at local and national levels. The findings will inform the extent to which a CGA-driven care plan may significantly reduce functional impairment and improve patient and caregiver satisfaction.

trial registrationClinicalTrials.gov ID: NCT06842459 – registered February 24, 2025 – retrospectively registered.

Indexed as

Diabetes Mellitus, Type 2Geriatric AssessmentPhysical Functional PerformanceAgedFemaleHumansMaleComprehensive geriatric assessmentDiabetesShort physical performance battery

Identifiers

PMID41316005
PMCPMC12661880

What Socratic holds

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LicenceCC BY
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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 Socratic graph.