Clinical Efficacy of Insulin Pumps in Type 1 Diabetes Mellitus Patients in Spain
Clinical Efficacy of Continuous Subcutaneous Insulin Infusion in Type 1 Diabetes Mellitus Patients in Spain
1 other identifier
observational
2,977
1 country
25
Brief Summary
Observational cross-sectional multicenter study about clinical efficacy of insulin pumps in type 1 diabetes mellitus patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
Shorter than P25 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2021
CompletedFirst Posted
Study publicly available on registry
February 18, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedFebruary 9, 2022
February 1, 2022
4 months
February 12, 2021
February 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HbA1C
Glycated haemoglobin A1C
During the procedure
Secondary Outcomes (12)
TIR
During the procedure
TAR
During the procedure
TUR
During the procedure
Clinical significant hypoglycemia
During the procedure
MIG
During the procedure
- +7 more secondary outcomes
Study Arms (1)
Insulin pump
All patient treated with insulin pump.
Interventions
Eligibility Criteria
All type 1 diabetes patients treated with continuous subcutaneous insulin infusion in Spain.
You may qualify if:
- Type 1 diabetes patients treated with insulin pump.
- Medical treatment received in Spain.
You may not qualify if:
- \- Any other kinds of diabetes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Castilla-La Mancha Health Servicelead
- Spanish Diabetes Associationcollaborator
Study Sites (25)
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital San Joan de Deu
Esplugues de Llobregat, Barcelona, 08950, Spain
Hospital Universitario Mutua de Tarrasa
Terrassa, Barcelona, 08221, Spain
Hospital Universitario de Jerez
Jerez de la Frontera, Cadiz, 11407, Spain
Hospital Universitario de Santiago de Compostela
Santiago de Compostela, La Coruña, 15706, Spain
Hospital Infanta Sofía
San Sebastián de los Reyes, Madrid, 28703, Spain
Hospital Universitario Carlos Haya
Málaga, Malaga, 29010, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Malaga, 29010, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008, Spain
Badajoz University Hospital
Badajoz, 06080, Spain
Hospital Clínic i Provincial
Barcelona, 08036, Spain
Hospital Santa Creu i Sant Pau
Barcelona, 08041, Spain
Hospital Universitario de Basurto
Bilbao, 48013, Spain
Obispo Rafael Torija, St.
Ciudad Real, 13005, Spain
Centro Medico D-Medical
Madrid, 28001, Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28007, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario Clínico San Carlos
Madrid, 28040, Spain
Clinica DiaLibre
Madrid, 28702, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
Hospital Universitario Virgen Macarena
Seville, 41013, Spain
Hospital Universitario Joan XXIII
Tarragona, 43005, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Hospital Universitario y Politécnico La Fe
Valencia, 46026, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, 47003, Spain
Related Publications (7)
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.
PMID: 3517648BACKGROUNDEffect 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.
PMID: 8040759BACKGROUNDYeh 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.
PMID: 22777524BACKGROUNDSastre 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.
PMID: 23039989BACKGROUNDBeato-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.
PMID: 29278712BACKGROUNDMoreno-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.
PMID: 31199682BACKGROUNDMoreno-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.
PMID: 35947087DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 9 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Endocrinologist
Study Record Dates
First Submitted
February 12, 2021
First Posted
February 18, 2021
Study Start
September 1, 2021
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
February 9, 2022
Record last verified: 2022-02