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

February 8, 2022 updated by: Jesús Moreno Fernández, Castilla-La Mancha Health Service

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

2977

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badajoz, Spain, 06080
        • Badajoz University Hospital
      • Barcelona, Spain, 08036
        • Hospital Clinic I Provincial
      • Barcelona, Spain, 08041
        • Hospital Santa Creu i Sant Pau
      • Bilbao, Spain, 48013
        • Hospital Universitario de Basurto
      • Ciudad Real, Spain, 13005
        • Obispo Rafael Torija, St.
      • Madrid, Spain, 28034
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
      • Madrid, Spain, 28040
        • Hospital Universitario Clinico San Carlos
      • Madrid, Spain, 28001
        • Centro Medico D-Medical
      • Madrid, Spain, 28702
        • Clinica DiaLibre
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen Macarena
      • Tarragona, Spain, 43005
        • Hospital Universitario Joan XXIII
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
      • Valencia, Spain, 46026
        • Hospital Universitario y Politécnico La Fe
      • Valladolid, Spain, 47003
        • Hospital Clínico Universitario de Valladolid
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitario Germans Trias i Pujol
      • Esplugues De Llobregat, Barcelona, Spain, 08950
        • Hospital San Joan de Deu
      • Terrassa, Barcelona, Spain, 08221
        • Hospital Universitario Mutua de Tarrasa
    • Cadiz
      • Jerez De La Frontera, Cadiz, Spain, 11407
        • Hospital Universitario de Jerez
    • La Coruña
      • Santiago De Compostela, La Coruña, Spain, 15706
        • Hospital Universitario de Santiago de Compostela
    • Madrid
      • San Sebastián De Los Reyes, Madrid, Spain, 28703
        • Hospital Infanta Sofia
    • Malaga
      • Málaga, Malaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
      • Málaga, Malaga, Spain, 29010
        • Hospital Universitario Carlos Haya
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Complejo Hospitalario de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All type 1 diabetes patients treated with continuous subcutaneous insulin infusion in Spain.

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Any other kinds of diabetes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Insulin pump
All patient treated with insulin pump.
Device: Insulin pump
Treatment with continuous subcutaneous insulin infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1C
Time Frame: During the procedure
Glycated haemoglobin A1C
During the procedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Castilla-La Mancha Health Service

Collaborators

Spanish Diabetes Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

February 12, 2021

First Submitted That Met QC Criteria

February 17, 2021

First Posted (Actual)

February 18, 2021

Study Record Updates

Last Update Posted (Actual)

February 9, 2022

Last Update Submitted That Met QC Criteria

February 8, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-386

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

IPD will be available after studying each request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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