Clinical trial NCT04761094: Clinical Efficacy of Insulin Pumps in Type 1 Diabetes Mellitus Patients in Spain
Official title: Clinical Efficacy of Continuous Subcutaneous Insulin Infusion in Type 1 Diabetes Mellitus Patients in Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes
Treatment
Insulin pump
Continuous subcutaneous insulin infusion
Lead sponsor: Castilla-La Mancha Health Service
Sponsor class: OTHER
Collaborators: name: Spanish Diabetes Association
First posted: 2021-02-18
Enrollment: 2977
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All type 1 diabetes patients treated with continuous subcutaneous insulin infusion in Spain.

Brief summary: Observational cross-sectional multicenter study about clinical efficacy of insulin pumps in type 1 diabetes mellitus patients.

Detailed description: Observational cross-sectional multicenter study about clinical efficacy of continuous subcutaneous insulin infusion in type 1 diabetes mellitus patients.

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.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes patients treated with insulin pump.
* Medical treatment received in Spain.

Exclusion Criteria:

- Any other kinds of diabetes.

Primary outcomes:
measure: HbA1C
timeFrame: During the procedure
Secondary outcomes:
measure: TIR
timeFrame: During the procedure
measure: TAR
timeFrame: During the procedure
measure: TUR
timeFrame: During the procedure
measure: Clinical significant hypoglycemia
timeFrame: During the procedure
measure: MIG
timeFrame: During the procedure
measure: %CV
timeFrame: During the procedure
measure: Adherence to CGM
timeFrame: During the procedure
measure: Weight
timeFrame: During the procedure
measure: Insulin dose
timeFrame: During the procedure
measure: DKA
timeFrame: During the procedure
measure: Severe hypoglycemia
timeFrame: During the procedure
measure: Hospital admission
timeFrame: During the procedure
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
state: Barcelona
city: Esplugues De Llobregat
country: Spain
facility: Hospital San Joan de Deu
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Universitario Mutua de Tarrasa
state: Barcelona
city: Jerez De La Frontera
country: Spain
facility: Hospital Universitario de Jerez
state: Cadiz
city: Santiago De Compostela
country: Spain
facility: Hospital Universitario de Santiago de Compostela
state: La Coruña
city: San Sebastián De Los Reyes
country: Spain
facility: Hospital Infanta Sofía
state: Madrid
city: Málaga
country: Spain
facility: Hospital Universitario Carlos Haya
state: Malaga
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
state: Malaga
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Badajoz
country: Spain
facility: Badajoz University Hospital
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
city: Bilbao
country: Spain
facility: Hospital Universitario de Basurto
city: Ciudad Real
country: Spain
facility: Obispo Rafael Torija, St.
city: Madrid
country: Spain
facility: Centro Medico D-Medical
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos
city: Madrid
country: Spain
facility: Clinica DiaLibre
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Tarragona
country: Spain
facility: Hospital Universitario Joan XXIII
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.