Evidence mapPaperPMID 41210384Full record

ArticleEClinicalMedicine2025

Trends in baseline HbA1c and body-mass index in randomised trials of people with type 1 diabetes from 1993 to 2025: an IMI2 SOPHIA systematic review and meta-analysis.

Amar D E van Laar, Laura Gallardo-Nuell, Sofia Pazmino Lucio, Margaretha M Visser, Ann Mertens, Roman Vangoitsenhoven, Pieter Gillard, Ebaa Al Ozairi, Carel W Le Roux, Jonathan Rosen and 6 more

Abstract read
In one paragraph

Article in EClinicalMedicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Observational
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

16 authors.

Amar D E van LaarClinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium.
Laura Gallardo-NuellDepartment of Diabetes, Endocrinology and Nutrition, Dr. Josep Trueta University Hospital, Girona, Spain.
Sofia Pazmino LucioClinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium.
Margaretha M VisserClinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium.
Ann MertensClinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium.
Roman VangoitsenhovenClinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium.
Pieter GillardClinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium.
Ebaa Al OzairiDepartment of Clinical Research and Clinical Trials, Dasman Diabetes Institute, Dasman, Kuwait.
Carel W Le RouxDiabetes Complications Research Centre, University College Dublin, Dublin, Ireland.
Jonathan RosenBreakthrough T1D, New York, NY, USA.
Carmen Hurtado Del PozoBreakthrough T1D, New York, NY, USA.
Yenny LealDepartment of Diabetes, Endocrinology and Nutrition, Dr. Josep Trueta University Hospital, Girona, Spain.
José Manuel Fernández-RealDepartment of Diabetes, Endocrinology and Nutrition, Dr. Josep Trueta University Hospital, Girona, Spain.
Chantal MathieuClinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium.
Nele SteenackersClinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium.
Bart Van der SchuerenClinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The prevalence of obesity has increased globally over the past few decades for the general population and people with type 2 diabetes. Existing research suggests that the body-mass index (BMI) of individuals living with type 1 diabetes has also increased substantially. This double burden of type 1 diabetes and obesity is concerning and may further increase the risk for microvascular and macrovascular complications associated with type 1 diabetes. We aimed to evaluate trends in BMI (as an indicator for adiposity/obesity) and haemoglobin A1c (HbA1c; as a measure of long-term glucose management) in people with type 1 diabetes, based on clinical trial data. Methods: In this systematic review and meta-analysis, PubMed, Web of Science, Scopus, Embase, Cochrane, and ClinicalTrials.gov were searched for clinical trials involving individuals with type 1 diabetes, covering all publications between January 1, 1993, and May 20, 2025. Randomised controlled trials (RCTs) were included when performed in adults, with baseline data on BMI and HbA1c, and featuring a sample size exceeding 100 participants. Studies were excluded if they applied overly narrow cut-off ranges (difference between upper and lower cut-off) for BMI (<5 kg/m Findings: 12,346 unique studies were identified, of which 148 were RCTs with a combined population of 56,411 participants were included. Included studies represented research conducted in Europe (55 studies), North America (25 studies), Asia (13 studies) and Oceania (2 studies), in addition to 53 multicontinental studies. BMI increased from 25.0 (24.7-25.3) kg/m Interpretation: The increasing trend in BMI may indicate that weight gain is also occurring in people with type 1 diabetes. More research is needed on the BMI and HbA1c trends in people with type 1 diabetes, using real-world data on the individual level and investigating these trends in relation to the insulin dose. Funding: The Stratification of Obesity Phenotypes to Optimize Future Obesity Therapy (SOPHIA) project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No. 875534, supported by the European Union's Horizon 2020 research and innovation program and EFPIA, with additional support from T1D Exchange, Breakthrough T1D (former JDRF), and Obesity Action Coalition.

Indexed as

BMIClinical trialsHbA1cMeta-analysisObesityType 1 diabetes

Identifiers

PMID41210384
PMCPMC12590235

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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 Socratic graph.