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

Completed

• Conditions: Type 1 Diabetes
• Interventions: Device: Insulin pump

• Registration Number: NCT04761094
• Lead Sponsor: Castilla-La Mancha Health Service

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.

Study Timeline

• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-17
• Study First Posted: 2021-02-18
• Study Start: 2021-09-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-08
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2977

Inclusion Criteria

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

Exclusion Criteria

• Any other kinds of diabetes.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Insulin pump	Insulin pump	All patient treated with insulin pump.

Primary Outcome Measures

Name	Time	Method
HbA1C	During the procedure	Glycated haemoglobin A1C

Secondary Outcome Measures

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

Trial Locations

Locations (25)

Badajoz University Hospital; 🇪🇸 Badajoz, Spain

Hospital Universitario Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital Universitario Mutua de Tarrasa; 🇪🇸 Terrassa, Barcelona, Spain

Hospital San Joan de Deu; 🇪🇸 Esplugues De Llobregat, Barcelona, Spain

Hospital Universitario de Jerez; 🇪🇸 Jerez De La Frontera, Cadiz, Spain

Hospital Universitario Carlos Haya; 🇪🇸 Málaga, Malaga, 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 Virgen de la Victoria; 🇪🇸 Málaga, Malaga, Spain

Complejo Hospitalario de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Hospital Clínic i Provincial; 🇪🇸 Barcelona, Spain

Hospital Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Universitario de Basurto; 🇪🇸 Bilbao, Spain

Centro Medico D-Medical; 🇪🇸 Madrid, Spain

Hospital Universitario Clínico San Carlos; 🇪🇸 Madrid, Spain

Obispo Rafael Torija, St.; 🇪🇸 Ciudad Real, Spain

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

Clinica DiaLibre; 🇪🇸 Madrid, Spain

Hospital Universitario Ramon y Cajal; 🇪🇸 Madrid, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital Universitario Joan XXIII; 🇪🇸 Tarragona, Spain

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain

Hospital Universitario y Politécnico La Fe; 🇪🇸 Valencia, Spain

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Spain