Evidence map›Paper›PMID 41124171›Full record

ArticlePloS one2025

GIP/GLP-1RA as adjunctive to automated insulin delivery in adults with Type 1 diabetes (the AID-JUNCT trial): Study protocol for a prospective, randomized, clinical trial.

Maria Carolina Fragozo-Ramos, Gabriela Schenker, Matthias Hepprich, Jaime Gallo-Villegas, Thomas Züger, Jose Garcia-Tirado

Abstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 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. 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

6 authors.

Maria Carolina Fragozo-RamosDepartment of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.ORCID https://orcid.org/0000-0002-6657-9989
Gabriela SchenkerDepartment of Endocrinology and Metabolic Diseases, Kantonsspital Olten, Olten, Switzerland.
Matthias HepprichUniversity of Basel, Medical Faculty, Basel, Switzerland.
Jaime Gallo-VillegasFaculty of Medicine, Sports Medicine Postgraduate Program and GRINMADE Research Group, University of Antioquia, Medellín, Colombia.ORCID https://orcid.org/0000-0002-6296-5110
Thomas ZügerDepartment of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.ORCID https://orcid.org/0000-0001-6190-7405
Jose Garcia-TiradoDepartment of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.ORCID https://orcid.org/0000-0002-9970-2162

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGlycemic control in type 1 diabetes (T1D) remains a challenge, with 20-30% of adults achieving an A1c target of <7%. Glucagon-like peptide 1 receptor agonist (GLP-1 RA) and dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 RA (GIP/GLP-1 RA) have emerged as a promising therapy in T1D. Previous studies have shown that patients with T1D can significantly improve glycemic control while experiencing a reduction in insulin dose and body weight when long-acting GLP-1RAs or GIP/GLP-1RAs are added to insulin therapy. However, randomized controlled trials (RCT) are still insufficient.

methodsThis is a prospective, randomized, parallel-group, open-label, superiority-controlled design that evaluates the safety and efficacy of adding tirzepatide to insulin therapy in participants with T1D under automated insulin delivery (AID) control. We will enroll 42 participants aged 18-65 years with confirmed T1D diagnosis ≥12 months, currently on AID insulin therapy for at least three months, with A1C ≥ 6.5% and ≤ 10%, and BMI ≥ 23 kg/m2. Participants will be randomized in a 1:1 ratio to either tirzepatide with a target dosage of 5.0 mg (after titration) or standard of care (SoC) for 16 weeks. The primary endpoint is continuous glucose monitoring (CGM)-measured percent time spent between 3.9 and 10.0 mmol/L (TIR) from baseline to follow-up after 16 weeks of treatment. Secondary endpoints include: the CGM-measured change in 24/7 percent time >10.0 mmol/L, > 13.9 mmol/L, < 3.9 mmol/L, < 3.0 mmol/L. The exploratory endpoints include: the change in body mass index (BMI), liver steatosis (MASLD), and body composition. Safety outcomes include severe hypoglycemia, diabetic ketoacidosis (DKA), and refractory gastrointestinal side effects. DISCUSSION: This is the first prospective study to investigate the safety and efficacy of tirzepatide (GIP/GLP1-RAs) as an adjuvant therapy to AID in T1D. This study may contribute unique data to significantly improving glucose and cardio-metabolic outcomes, re-directing attention to further treatment in T1D beyond insulin therapies.

Indexed as

Diabetes Mellitus, Type 1Gastric Inhibitory PolypeptideHypoglycemic AgentsInsulinAdolescentAdultAgedBlood GlucoseEquivalence Trials as TopicFemaleHumansMaleMiddle AgedProspective StudiesRandomized Controlled Trials as TopicYoung AdultBlood GlucoseGastric Inhibitory PolypeptideHypoglycemic AgentsInsulin

Identifiers

PMID41124171
PMCPMC12543135

What Socratic holds

Textmetadata
LicenceCC BY
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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.