The T1DWATCH Study: a Screening for Type 1 Diabetes Autoantibodies in Children for Early Detection and Intervention.

NCT07492550 | Not Yet Recruiting

• 1 other identifier: T1D_Watch
• Study Type: observational
• Target: 2,200
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to identify early-stage type 1 diabetes (T1D) in children aged 2-6 and 8-10 years through autoantibody (Ab) screening, genetic and immunological analyses, and to evaluate the effectiveness of educational interventions, as well as the feasibility and acceptability of their implementation. It is a prospective cohort study involving 2,169 children attending primary healthcare centres in the Barcelonès area. Eligible participants will be those engaged in routine paediatric preventive programe with parental informed consent. The screening process consists of three visits: Visit 1: Capillary blood collection for 3 T1D related Ab (3-screen ELISA). Visit 2: Confirmation of positive results through a new venous blood sample to determine single T1D related Ab and metabolic tests (fasting glucose, HbA1c, C-peptide), HLA, imme cell study. Visit 3: Risk stratification based on Ab presence: Group A (negative), Group B (one positive Ab, at risk of T1D), and Group C (two positive Ab, diagnosed at stage 1 or 2). Immunological and metabolic changes will be monitored, and screening effectiveness will be assessed in terms of sensitivity, specificity, and false positive/negative rates. The association between HLA genotype and Ab positivity will be analysed using logistic regression. A cost-effectiveness analysis will be conducted alongside a qualitative evaluation of parents' and stakeholders' perceptions regarding the screening process.This study will provide evidence to optimise early T1D detection and its implementation in primary care.

Conditions

Diabete Type 1

Keywords

Diabetes TYPE 1; Children; Autoantibodies; Screening; Primary Health Care; Autoimmunity

Outcome Measures

Primary Outcomes (1)

• Number of detected cases

  Key outcomes include the number of detected cases, defined by the presence of at least one autoantibody or two confirmed Ab.

  Baseline through study completion, an average of 2 years

Study Arms (3)

Grup A

No Ab. Negative screening test.

Grup B - at risk T1D

Only one positive Ab.

Grup C - Stage 1, 2 T1D

Two positive Ab

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of children (boys and girls) aged 2-10 years from the three municipalities of Barcelona, spain.

You may qualify if:

• Age corresponding to one of the predefined screening groups:
• Young children: 2-6 years
• Older children: 7-10 years
• Attendance at routine pediatric visits within the Preventive Activities and Health Promotion Programme in Childhood in Catalonia ("Creixer amb Salut") at the specified ages (2-10 years)
• Written informed consent provided by parents or legal guardians

You may not qualify if:

• Presence of primary immunodeficiency
• Current treatment with immunosuppressive therapy
• Ongoing participation in another clinical trial
• Refusal to participate or inability to comply with study procedures

Sponsors & Collaborators

• Germans Trias i Pujol Research Institute | IGTP: collaborator
• Institut de Recerca Germans Trias i Pujol: collaborator
• Fabiana Sherine Ganem dos Santos: lead

Related Publications (44)

• https://salutpublica.gencat.cat/web/.content/minisite/aspcat/promocio_salut/infancia-adolescencia/02infancia-amb- salut/protocol-preventiu-edat-pediatrica-2025.pdf

  BACKGROUND

• Luger TA, Kalden D, Scholzen TE, Brzoska T. alpha-melanocyte-stimulating hormone as a mediator of tolerance induction. Pathobiology. 1999;67(5-6):318-21. doi: 10.1159/000028089.

  PMID: 10725812 BACKGROUND

• Besser REJ, Ng SM, Gregory JW, Dayan CM, Randell T, Barrett T. General population screening for childhood type 1 diabetes: is it time for a UK strategy? Arch Dis Child. 2022 Sep;107(9):790-795. doi: 10.1136/archdischild-2021-321864. Epub 2021 Nov 5.

  PMID: 34740879 BACKGROUND

• Brady RC. Index of suspicion. Case 2. Diagnosis: gonorrhea conjunctivitis. Pediatr Rev. 1997 May;18(5):175-7. No abstract available.

  PMID: 9114719 BACKGROUND

• Sims EK, Besser REJ, Dayan C, Geno Rasmussen C, Greenbaum C, Griffin KJ, Hagopian W, Knip M, Long AE, Martin F, Mathieu C, Rewers M, Steck AK, Wentworth JM, Rich SS, Kordonouri O, Ziegler AG, Herold KC; NIDDK Type 1 Diabetes TrialNet Study Group. Screening for Type 1 Diabetes in the General Population: A Status Report and Perspective. Diabetes. 2022 Apr 1;71(4):610-623. doi: 10.2337/dbi20-0054.

  PMID: 35316839 BACKGROUND

• Li R, Zhang P, Barker LE, Chowdhury FM, Zhang X. Cost-effectiveness of interventions to prevent and control diabetes mellitus: a systematic review. Diabetes Care. 2010 Aug;33(8):1872-94. doi: 10.2337/dc10-0843.

  PMID: 20668156 BACKGROUND

• Chou WG, Pogell BM. Pamamycin inhibits nucleoside and inorganic phosphate transport in Staphylococcus aureus. Biochem Biophys Res Commun. 1981 May 15;100(1):344-50. doi: 10.1016/s0006-291x(81)80102-7. No abstract available.

  PMID: 7259754 BACKGROUND

• Bonventre PF, Nickol AD, Ball EJ, Michael JG, Bubel HC. Development of protective immunity against bacterial and viral infections in tumor-bearing mice coincident with suppression of tumor immunity. J Reticuloendothel Soc. 1982 Jul;32(1):25-35.

  PMID: 6290658 BACKGROUND

• Haller MJ, Bell KJ, Besser REJ, Casteels K, Couper JJ, Craig ME, Elding Larsson H, Jacobsen L, Lange K, Oron T, Sims EK, Speake C, Tosur M, Ulivi F, Ziegler AG, Wherrett DK, Marcovecchio ML. ISPAD Clinical Practice Consensus Guidelines 2024: Screening, Staging, and Strategies to Preserve Beta-Cell Function in Children and Adolescents with Type 1 Diabetes. Horm Res Paediatr. 2024;97(6):529-545. doi: 10.1159/000543035. Epub 2024 Dec 11.

  PMID: 39662065 BACKGROUND

• Taylor PN, Collins KS, Lam A, Karpen SR, Greeno B, Walker F, Lozano A, Atabakhsh E, Ahmed ST, Marinac M, Latres E, Senior PA, Rigby M, Gottlieb PA, Dayan CM; Trial Outcome Markers Initiative collaboration. C-peptide and metabolic outcomes in trials of disease modifying therapy in new-onset type 1 diabetes: an individual participant meta-analysis. Lancet Diabetes Endocrinol. 2023 Dec;11(12):915-925. doi: 10.1016/S2213-8587(23)00267-X. Epub 2023 Nov 3.

  PMID: 37931637 BACKGROUND

• Fonolleda M, Murillo M, Vazquez F, Bel J, Vives-Pi M. Remission Phase in Paediatric Type 1 Diabetes: New Understanding and Emerging Biomarkers. Horm Res Paediatr. 2017;88(5):307-315. doi: 10.1159/000479030. Epub 2017 Aug 3.

  PMID: 28772271 BACKGROUND

• Boulenger JP, Uhde TW. Caffeine consumption and anxiety: preliminary results of a survey comparing patients with anxiety disorders and normal controls. Psychopharmacol Bull. 1982 Oct;18(4):53-7. No abstract available.

  PMID: 7156298 BACKGROUND

• Gomez-Munoz L, Perna-Barrull D, Villalba A, Rodriguez-Fernandez S, Ampudia RM, Teniente-Serra A, Vazquez F, Murillo M, Perez J, Corripio R, Bel J, Vives-Pi M. NK Cell Subsets Changes in Partial Remission and Early Stages of Pediatric Type 1 Diabetes. Front Immunol. 2021 Jan 25;11:611522. doi: 10.3389/fimmu.2020.611522. eCollection 2020.

  PMID: 33569058 BACKGROUND

• Vandamme C, Kinnunen T. B cell helper T cells and type 1 diabetes. Scand J Immunol. 2020 Oct;92(4):e12943. doi: 10.1111/sji.12943.

  PMID: 32697399 BACKGROUND

• Larsen P. [Police always ready for a noncommitted talk. Interview by Anne Vesterdal]. Sygeplejersken. 1997 Oct 31;97(44):4-7. No abstract available. Danish.

  PMID: 9418549 BACKGROUND

• Bischof LJ, Martin CC, Svitek CA, Stadelmaier BT, Hornbuckle LA, Goldman JK, Oeser JK, Hutton JC, O'Brien RM. Characterization of the mouse islet-specific glucose-6-phosphatase catalytic subunit-related protein gene promoter by in situ footprinting: correlation with fusion gene expression in the islet-derived betaTC-3 and hamster insulinoma tumor cell lines. Diabetes. 2001 Mar;50(3):502-14. doi: 10.2337/diabetes.50.3.502.

  PMID: 11246869 BACKGROUND

• Luo S, Zhang L, Wei C, Guo C, Meng Z, Zeng H, Hou L, Wang L, Liu Z, Du Y, Tan S, Zhang Y, Xu X, Liang L, Zhou Y. TCL1A in naive B cells as a therapeutic target for type 1 diabetes. EBioMedicine. 2025 Mar;113:105593. doi: 10.1016/j.ebiom.2025.105593. Epub 2025 Feb 12.

  PMID: 39946833 BACKGROUND

• Ueda M, Nomura G, Shibata H, Nishida H, Moriyama A, Kumagai E, Toshima H. Assessment of cardiopulmonary baroreflex function in hypertensive and normotensive subjects with or without hypertensive relatives. Clin Exp Pharmacol Physiol Suppl. 1989;15:89-92. doi: 10.1111/j.1440-1681.1989.tb03000.x.

  PMID: 2805448 BACKGROUND

• Yamaoka K, Koizumi K, Asahina Y, Tajiri K, Sakai Y, Tazawa J, Akabane H, Marumo F, Sato C. [Hepatocellular carcinoma associated with autoimmune hepatitis--a case report and a review of the literatures]. Nihon Shokakibyo Gakkai Zasshi. 1994 Jul;91(7):1262-7. No abstract available. Japanese.

  PMID: 8065060 BACKGROUND

• Fernandez J, Blanca M, Soriano V, Sanchez J, Juarez C. Epidemiological study of the prevalence of allergic reactions to Hymenoptera in a rural population in the Mediterranean area. Clin Exp Allergy. 1999 Aug;29(8):1069-74. doi: 10.1046/j.1365-2222.1999.00614.x.

  PMID: 10457110 BACKGROUND

• Wilson SC, Oakey RE, Scott JS. In-vivo and in-vitro endocrine investigation of pure gonadal dysgenesis. Clin Endocrinol (Oxf). 1988 Nov;29(5):485-94. doi: 10.1111/j.1365-2265.1988.tb03697.x.

  PMID: 3253030 BACKGROUND

• Long KJ. Abused statistical language in journal articles. Am J Med. 1987 Sep;83(3):607-8. doi: 10.1016/0002-9343(87)90793-5. No abstract available.

  PMID: 3661605 BACKGROUND

• Scliar M. [Premarital examination: a rite of passage in Public Health]. Cad Saude Publica. 1997 Jul;13(3):527-530. doi: 10.1590/s0102-311x1997000300028. Portuguese.

  PMID: 10886892 BACKGROUND

• Gingerich PD. The development of sexual dimorphism in the bony pelvis of the squirrel monkey. Anat Rec. 1972 Mar;172(3):589-95. doi: 10.1002/ar.1091720312. No abstract available.

  PMID: 4622200 BACKGROUND

• Matthews PV, Newell LM. Disease management at a crossroads. Healthc Inform. 2001 Jul;18(7):38-41. No abstract available.

  PMID: 11766439 BACKGROUND

• Shawa T, Cohen R, Jansen D, McKinnon W. Revisiting breast masses with the plastic surgeon: suggestions for biopsy and resection. Am Surg. 2000 Nov;66(11):1077-9.

  PMID: 11090024 BACKGROUND

• Carter DH, Scully AJ, Davies RM, Aaron JE. Evidence for phosphoprotein microspheres in bone. Histochem J. 1998 Sep;30(9):677-86. doi: 10.1023/a:1003490506980.

  PMID: 9870768 BACKGROUND

• Henon P, Sovalat H, Becker M, Arkam Y, Ojeda-Uribe M, Raidot JP, Husseini F, Wunder E, Bourderont D, Audhuy B. Primordial role of CD34+ 38- cells in early and late trilineage haemopoietic engraftment after autologous blood cell transplantation. Br J Haematol. 1998 Nov;103(2):568-81. doi: 10.1046/j.1365-2141.1998.01066.x.

  PMID: 9827938 BACKGROUND

• Pontiroli AE, De Castro e Silva E, Mazzoleni F, Alberetto M, Baio G, Pellicciotta G, De Pasqua A, Stella L, Girardi AM, Pozza G. The effect of histamine and H1 and H2 receptors on prolactin and luteinizing hormone release in humans: sex differences and the role of stress. J Clin Endocrinol Metab. 1981 May;52(5):924-8. doi: 10.1210/jcem-52-5-924.

  PMID: 7228996 BACKGROUND

• Demant F, Gubas J, Predmersky M, Vereb J. [Takayasu syndrome in a 13-year-old girl]. Bratisl Lek Listy. 1970 Dec;54(6):675-81. No abstract available. Slovak.

  PMID: 5491594 BACKGROUND

• Suzuki H. [Heme transport from mitochondria to apocytochrome b5 incorporated into phospholipid vesicles by cytosolic liver protein]. Hokkaido Igaku Zasshi. 1986 Sep;61(5):800-6. Japanese.

  PMID: 3781470 BACKGROUND

• Fitch CW, Neville J. Nutrient intake of infants hospitalized with lower respiratory tract infections. J Am Diet Assoc. 2001 Jun;101(6):690-2. doi: 10.1016/S0002-8223(01)00173-0. No abstract available.

  PMID: 11424550 BACKGROUND

• Sporisevic L, Hasanbegovic E, Hadzihasanovic E, Bajraktarevic A, Khatib H, Hamamdzic M. [Advantages and disadvantages in the use of central venous catheters in children with malignant diseases]. Med Arh. 1999;53(3 Suppl 2):19-22. Croatian.

  PMID: 10758755 BACKGROUND

• Nyman U. [Disastrous situation when it comes to vascular intervention! State-of-the-art endovascular treatment--if the radiology will manage to realize it]. Lakartidningen. 2000 Sep 27;97(39):4284-6. No abstract available. Swedish.

  PMID: 11076468 BACKGROUND

• Mallin K. A nested case-control study of bladder cancer incidence in a steel manufacturing plant. Am J Ind Med. 1998 Oct;34(4):393-8. doi: 10.1002/(sici)1097-0274(199810)34:43.0.co;2-y.

  PMID: 9750947 BACKGROUND

• Suzuki H, Fukuda H, Hirabayashi Y, Saitoh K, Igarashi T, Shimizu R. [Anesthetic management of a patient with May-Hegglin anomaly]. Masui. 2000 Aug;49(8):899-900. Japanese.

  PMID: 10998887 BACKGROUND

• Echeverri AF, Tobón GJ. Autoimmune diabetes mellitus (Type 1A) In: Anaya JM, Shoenfeld Y, Rojas-Villarraga A, et al., editors. Autoimmunity: From Bench to Bedside [Internet]. Bogota (Colombia): El Rosario University Press; 2013 Jul 18. Chapter 29. Available from: https://www.ncbi.nlm.nih.gov/books/NBK459476/

  BACKGROUND

• Jia X, Yu L. Understanding Islet Autoantibodies in Prediction of Type 1 Diabetes. J Endocr Soc. 2024 Jan 2;8(1):bvad160. doi: 10.1210/jendso/bvad160. eCollection 2023 Dec 1.

  PMID: 38169963 BACKGROUND

• Pihoker C, Gilliam LK, Hampe CS, Lernmark A. Autoantibodies in diabetes. Diabetes. 2005 Dec;54 Suppl 2:S52-61. doi: 10.2337/diabetes.54.suppl_2.s52.

  PMID: 16306341 BACKGROUND

• Makimattila S, Harjutsalo V, Forsblom C, Groop PH; FinnDiane Study Group. Every Fifth Individual With Type 1 Diabetes Suffers From an Additional Autoimmune Disease: A Finnish Nationwide Study. Diabetes Care. 2020 May;43(5):1041-1047. doi: 10.2337/dc19-2429. Epub 2020 Mar 5.

  PMID: 32139386 BACKGROUND

• Roep BO, Thomaidou S, van Tienhoven R, Zaldumbide A. Type 1 diabetes mellitus as a disease of the beta-cell (do not blame the immune system?). Nat Rev Endocrinol. 2021 Mar;17(3):150-161. doi: 10.1038/s41574-020-00443-4. Epub 2020 Dec 8.

  PMID: 33293704 BACKGROUND

• Dubey JP, Speer CA, Bowman DD, Horton KM, Venturini C, Venturini L. Experimental transmission of Sarcocystis speeri Dubey and Lindsay, 1999 from the South American opossum (Didelphis albiventris) to the North American opossum (Didelphis virginiana). J Parasitol. 2000 Jun;86(3):624-7. doi: 10.1645/0022-3395(2000)086[0624:ETOSSD]2.0.CO;2.

  PMID: 10864267 BACKGROUND

• Popoviciu MS, Kaka N, Sethi Y, Patel N, Chopra H, Cavalu S. Type 1 Diabetes Mellitus and Autoimmune Diseases: A Critical Review of the Association and the Application of Personalized Medicine. J Pers Med. 2023 Feb 26;13(3):422. doi: 10.3390/jpm13030422.

  PMID: 36983604 BACKGROUND

• Fokas AS, Liu QM. Nonlinear interaction of traveling waves of nonintegrable equations. Phys Rev Lett. 1994 May 23;72(21):3293-3296. doi: 10.1103/PhysRevLett.72.3293. No abstract available.

  PMID: 10056161 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Immune System Diseases

Study Officials

• Bibiana S Quirant, PhD

  Germans Trias i Pujol Research Institute | IGTP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Concepción V Fors, PhD

CONTACT

+34 607 07 25 92; cviolanf.mn.ics@gencat.cat

Fabiana G dos Santos, PhD

CONTACT

+34679080950; fganem@idiapjgol.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 25, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share