Clinical Efficacy of Insulin Pumps in Type 1 Diabetes Mellitus Patients in Spain

Type 1 Diabetes Clinical Trial

Official title:

Clinical Efficacy of Continuous Subcutaneous Insulin Infusion in Type 1 Diabetes Mellitus Patients in Spain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04761094
• Other study ID #: C-386
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: Castilla-La Mancha Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2977
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Type 1 diabetes patients treated with insulin pump.

• Medical treatment received in Spain.

Exclusion Criteria:

• Any other kinds of diabetes.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• Insulin pump
Treatment with continuous subcutaneous insulin infusion

Locations

Country	Name	City	State
Spain	Badajoz University Hospital	Badajoz
Spain	Hospital Universitario Germans Trias i Pujol	Badalona	Barcelona
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	Hospital San Joan de Deu	Esplugues De Llobregat	Barcelona
Spain	Hospital Universitario de Jerez	Jerez De La Frontera	Cadiz
Spain	Centro Medico D-Medical	Madrid
Spain	Clinica DiaLibre	Madrid
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario Clínico San Carlos	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Universitario Carlos Haya	Málaga	Malaga
Spain	Hospital Universitario Virgen de la Victoria	Málaga	Malaga
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Hospital Infanta Sofía	San Sebastián De Los Reyes	Madrid
Spain	Hospital Universitario de Santiago de Compostela	Santiago De Compostela	La Coruña
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Universitario Joan XXIII	Tarragona
Spain	Hospital Universitario Mutua de Tarrasa	Terrassa	Barcelona
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Universitario y Politécnico La Fe	Valencia
Spain	Hospital Clínico Universitario de Valladolid	Valladolid

Sponsors (2)

Lead Sponsor	Collaborator
Castilla-La Mancha Health Service	Spanish Diabetes Association

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Beato-Víbora P, Chico-Ballesteros A, Giménez M, Guerrero-Vázquez R, Barrio-Castellanos R, Goñi-Iriarte MJ, Díaz-Soto G, Merino-Torres JF, Moreno-Fernández J, Martínez-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. — View 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. — View Citation

Eisenbarth GS. Type I diabetes mellitus. A chronic autoimmune disease. N Engl J Med. 1986 May 22;314(21):1360-8. Review. — View Citation

Moreno-Fernandez J, Gomez FJ, Pinés P, González J, López J, López LM, Blanco B, Roa C, Herranz S, Muñoz-Rodríguez 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. — View Citation

Sastre J, Pinés PJ, Moreno J, Aguirre M, Blanco B, Calderón 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1C	Glycated haemoglobin A1C	During the procedure
Secondary	TIR	Time in range (TIR, 3.9-10 mmol/L, 70-180 mg/dL) of the interstitial glucose	During the procedure
Secondary	TAR	Time above range (TAR, >10 mmol/L, >180 mg/dL) of the interstitial glucose	During the procedure
Secondary	TUR	Time under range (TUR, <3.9 mmol/L, <70 mg/dL) of the interstitial glucose	During the procedure
Secondary	Clinical significant hypoglycemia	Time in clinical significant hypoglycemia (< 3 mmol/L, <54 mg/dL) of the interstitial glucose	During the procedure
Secondary	MIG	Mean interstitial glucose (mmol/L, mg/dL)	During the procedure
Secondary	%CV	Percentage of the variation coefficient (%, >36% is considered high levels)	During the procedure
Secondary	Adherence to CGM	Time of use of continuous glucose monitoring (% possible time of use)	During the procedure
Secondary	Weight	Total corporal weight (Kg)	During the procedure
Secondary	Insulin dose	Daily insulin dose requirements (UI/Kg/d)	During the procedure
Secondary	DKA	Number of diabetic ketoacidosis (number of events)	During the procedure
Secondary	Severe hypoglycemia	Number of severe hypoglycemia (number of events)	During the procedure
Secondary	Hospital admission	Number of hospital admission due to insulin pump (number of events)	During the procedure