Clinical Efficacy of Insulin Pumps in Type 1 Diabetes Mellitus Patients in Spain
NCT ID: NCT04761094
Last Updated: 2022-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2977 participants
OBSERVATIONAL
2021-09-01
2021-12-31
Brief Summary
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Detailed Description
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All clinical variables are gathered from the Spanish Insulin Pump National Registry.
Data analysis is conducted using SPSS (Chicago, IL) statistic software. Results are presented as mean +/- SD values. A paired Student's t-test or a Wilcoxon signed-rank test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. A P value \< 0.05 was considered statistically significant.
The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee. All participants provided written informed consent.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Insulin pump
All patient treated with insulin pump.
Insulin pump
Treatment with continuous subcutaneous insulin infusion
Interventions
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Insulin pump
Treatment with continuous subcutaneous insulin infusion
Eligibility Criteria
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Inclusion Criteria
* Medical treatment received in Spain.
Exclusion Criteria
ALL
No
Sponsors
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Spanish Diabetes Association
UNKNOWN
Castilla-La Mancha Health Service
OTHER
Responsible Party
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Jesús Moreno Fernández
Endocrinologist
Locations
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Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital San Joan de Deu
Esplugues de Llobregat, Barcelona, Spain
Hospital Universitario Mutua de Tarrasa
Terrassa, Barcelona, Spain
Hospital Universitario de Jerez
Jerez de la Frontera, Cadiz, Spain
Hospital Universitario de Santiago de Compostela
Santiago de Compostela, La Coruña, Spain
Hospital Infanta Sofía
San Sebastián de los Reyes, Madrid, Spain
Hospital Universitario Carlos Haya
Málaga, Malaga, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Malaga, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Badajoz University Hospital
Badajoz, , Spain
Hospital Clínic i Provincial
Barcelona, , Spain
Hospital Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario de Basurto
Bilbao, , Spain
Obispo Rafael Torija, St.
Ciudad Real, , Spain
Centro Medico D-Medical
Madrid, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario Clínico San Carlos
Madrid, , Spain
Clinica DiaLibre
Madrid, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Joan XXIII
Tarragona, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hospital Universitario y Politécnico La Fe
Valencia, , Spain
Hospital Clínico Universitario de Valladolid
Valladolid, , Spain
Countries
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References
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Eisenbarth GS. Type I diabetes mellitus. A chronic autoimmune disease. N Engl J Med. 1986 May 22;314(21):1360-8. doi: 10.1056/NEJM198605223142106. No abstract available.
Effect of intensive diabetes treatment on the development and progression of long-term complications in adolescents with insulin-dependent diabetes mellitus: Diabetes Control and Complications Trial. Diabetes Control and Complications Trial Research Group. J Pediatr. 1994 Aug;125(2):177-88. doi: 10.1016/s0022-3476(94)70190-3.
Yeh HC, Brown TT, Maruthur N, Ranasinghe P, Berger Z, Suh YD, Wilson LM, Haberl EB, Brick J, Bass EB, Golden SH. Comparative effectiveness and safety of methods of insulin delivery and glucose monitoring for diabetes mellitus: a systematic review and meta-analysis. Ann Intern Med. 2012 Sep 4;157(5):336-47. doi: 10.7326/0003-4819-157-5-201209040-00508.
Sastre J, Pines PJ, Moreno J, Aguirre M, Blanco B, Calderon D, Herranz S, Roa C, Lopez J; Grupo de estudio DIACAM 1. Metabolic control and treatment patterns in patients with type 1 diabetes in Castilla-La Mancha: the DIAbetes tipo 1 in Castilla La Mancha study. Endocrinol Nutr. 2012 Nov;59(9):539-46. doi: 10.1016/j.endonu.2012.07.003. Epub 2012 Oct 4. English, Spanish.
Beato-Vibora P, Chico-Ballesteros A, Gimenez M, Guerrero-Vazquez R, Barrio-Castellanos R, Goni-Iriarte MJ, Diaz-Soto G, Merino-Torres JF, Moreno-Fernandez J, Martinez-Brocca MA; Diabetes Technology Working Group of the Spanish Diabetes Association. A national survey on the efficacy and safety of continuous subcutaneous insulin infusion in patients with type 1 diabetes in Spain. Diabetes Res Clin Pract. 2018 Mar;137:56-63. doi: 10.1016/j.diabres.2017.12.009. Epub 2017 Dec 24.
Moreno-Fernandez J, Gomez FJ, Pines P, Gonzalez J, Lopez J, Lopez LM, Blanco B, Roa C, Herranz S, Munoz-Rodriguez JR. Continuous Subcutaneous Insulin Infusion in Adult Type 1 Diabetes Mellitus Patients: Results from a Public Health System. Diabetes Technol Ther. 2019 Aug;21(8):440-447. doi: 10.1089/dia.2019.0097. Epub 2019 Jun 13.
Moreno-Fernandez J, Chico A, Martinez-Brocca MA, Beato-Vibora PI, Vidal M, Piedra M, Quiros C, Munoz-Rodriguez JR; SPAIP Registry Study. Continuous Subcutaneous Insulin Infusion in Type 1 Diabetes Mellitus Patients: Results from the Spanish National Registry. Diabetes Technol Ther. 2022 Dec;24(12):898-906. doi: 10.1089/dia.2022.0207. Epub 2022 Sep 6.
Other Identifiers
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C-386
Identifier Type: -
Identifier Source: org_study_id
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