Evidence map›Paper›PMID 27531506›Full record

Trial reportDiabetologia2016

Years of life gained by multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria: 21 years follow-up on the Steno-2 randomised trial.

Peter Gæde, Jens Oellgaard, Bendix Carstensen, Peter Rossing, Henrik Lund-Andersen, Hans-Henrik Parving, Oluf Pedersen

3 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetologia, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT05535322. Cited by 197 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
197citing papers in PubMed, 12 pooled it
52.5field-weighted citation impact, top 1% of its field
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.

NCT05535322 completed

Real-world Evaluation of GLP-1 Receptor Agonists (GLP-1RA) on Efficacy and Persistence, Adherence and Therapeutic Inertia Among Type 2 Diabetes Adults With Obesity in the Department of Health of Valencia Clínico-Malvarrosa

Ran2014Enrolled26,944Registered outcomes12Posted comparisons0ConditionsObesity, Type 2 DiabetesArmsGLP-1RA, Insulin, Miscellany, SGLT2i
PMID 21457427PMID 29364585PMID 32347181PMID 32295809PMID 31673896PMID 31422062PMID 31028689PMID 30677504PMID 30291013PMID 29675797PMID 28834075PMID 28801475other papers from this trial
Open the trial in the graph
NCT00320008 naunknown statusnot on this map

Intensified Multifactorial Intervention in Patients With Type 2 Diabetes and Microalbuminuria

TypeinterventionalSponsorPeter GædeRan1992 to 2025Enrolled160ConditionsType 2 DiabetesArmsDiet, Exercise, Stop smoking, Glucose lowering therapy, Blood pressure lowering therapy
NCT03413215 naunknown statusnot on this mapstarted 2019, after this paper: background citation

Effects of Multidisciplinary Intensive Targeted Care in Improving Diabetes Outcomes: a Randomized Controlled Pilot Study - the Integrated Diabetes Education, Awareness and Lifestyle Modification in Singapore (IDEALS) Program

TypeinterventionalSponsorChangi General HospitalRan2019 to 2022Enrolled50ConditionsDiabetes Mellitus, Type 2, Diabetic Nephropathy, HypertensionArmsIntensive
3 · Its place in the literature

Who cites it

197 citing papers in PubMed, 12 syntheses or guidelines pooled it, 518 citations in OpenAlex.

  1. Guideline
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  4. Blood pressure control for diabetic retinopathy.The Cochrane database of systematic reviews · 2023
    Pooled it
  5. Protein restriction for diabetic kidney disease.The Cochrane database of systematic reviews · 2023
    Pooled it
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  8. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline
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  10. Guideline
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  13. Trial
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137 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 2 countries.

Peter GædeDepartment of Cardiology and Endocrinology, Slagelse Hospital, Slagelse, Denmark.
Jens OellgaardDepartment of Cardiology and Endocrinology, Slagelse Hospital, Slagelse, Denmark.
Bendix CarstensenSteno Diabetes Center, Gentofte, Denmark.
Peter RossingSteno Diabetes Center, Gentofte, Denmark.
Henrik Lund-AndersenSteno Diabetes Center, Gentofte, Denmark.
Hans-Henrik ParvingFaculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.
Oluf PedersenNovo Nordisk Foundation Center for Basic Metabolic Research, Section of Metabolic Genetics, Faculty of Health and Medical Sciences, University of Copenhagen, Universitetsparken 1, DK-2100, Copenhagen, Denmark. oluf@sund.ku.dk.
Steno Diabetes Center · DKUniversity of Southern Denmark · DKNovo Nordisk Foundation · DKRigshospitalet · DKUniversity of Copenhagen · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aims/hypothesisThe aim of this work was to study the potential long-term impact of a 7.8 years intensified, multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria in terms of gained years of life and years free from incident cardiovascular disease.

methodsThe original intervention (mean treatment duration 7.8 years) involved 160 patients with type 2 diabetes and microalbuminuria who were randomly assigned (using sealed envelopes) to receive either conventional therapy or intensified, multifactorial treatment including both behavioural and pharmacological approaches. After 7.8 years the study continued as an observational follow-up with all patients receiving treatment as for the original intensive-therapy group. The primary endpoint of this follow-up 21.2 years after intervention start was difference in median survival time between the original treatment groups with and without incident cardiovascular disease. Non-fatal endpoints and causes of death were adjudicated by an external endpoint committee blinded for treatment allocation.

resultsThirty-eight intensive-therapy patients vs 55 conventional-therapy patients died during follow-up (HR 0.55 [95% CI 0.36, 0.83], p = 0.005). The patients in the intensive-therapy group survived for a median of 7.9 years longer than the conventional-therapy group patients. Median time before first cardiovascular event after randomisation was 8.1 years longer in the intensive-therapy group (p = 0.001). The hazard for all microvascular complications was decreased in the intensive-therapy group in the range 0.52 to 0.67, except for peripheral neuropathy (HR 1.12). CONCLUSIONS/

interpretationAt 21.2 years of follow-up of 7.8 years of intensified, multifactorial, target-driven treatment of type 2 diabetes with microalbuminuria, we demonstrate a median of 7.9 years of gain of life. The increase in lifespan is matched by time free from incident cardiovascular disease.

trial registrationClinicalTrials.gov registration no. NCT00320008.

fundingThe study was funded by an unrestricted grant from Novo Nordisk A/S.

Indexed as

AdultAgedAged, 80 and overAlbuminuriaCardiovascular DiseasesDiabetes ComplicationsDiabetes Mellitus, Type 2Diabetic NephropathiesDiabetic NeuropathiesDiabetic RetinopathyFemaleFollow-Up StudiesHumansHypoglycemic AgentsMaleMiddle AgedHypoglycemic AgentsAlbuminuriaCardiovascular diseaseDiabetes complicationsDiabetes mellitus, type 2Diabetic nephropathyDiabetic neuropathyDiabetic retinopathyFollow-up studiesHumans

Identifiers

PMID27531506
PMCPMC5506099
OpenAlexW2513040800

What Socratic holds

Textmetadata
LicenceCC BY
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.