Clinical Effects of Intermitent Continuous Glucose Monitoring in Type 1 Diabetes

NCT ID: NCT05095610

Last Updated: 2022-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1121 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-05-06

Brief Summary

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Observational cross-sectional multicenter study about clinical effect of intermitent continuous glucose monitoring (Flash) in adult type 1 diabetes patients in an Spanish public health system.

Detailed Description

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Observational cross-sectional multicenter study about clinical effect of intermitent continuous glucose monitoring (Flash) in adult type 1 diabetes patients in an Spanish public health system.

All clinical variables are gathered from chart review. Data analysis is conducted using SPSS statistic software. Results are presented as mean +/- SD values. A paired Student´s t-test or Wilconxon signed test were used fr the analysis differences. Comparison between proportions were analyzed using a chi-square test. A P value \<0.05 was considered statistically significant.

The protocolo was apporved by the reference Castilla-La Mancha Public Health Service Ethic Commitee. All participants provided written consent.

Conditions

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Type 1 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Adult Type 1 Diabetes

All adult patients with type 1 diabetes previously followed in the DIACAM study (see bellow reference).

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.

Flash

Intervention Type DEVICE

Use of the device FreeStyle Libre, only commercialized system for intermitent continuous glucose monitoring.

Interventions

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Flash

Use of the device FreeStyle Libre, only commercialized system for intermitent continuous glucose monitoring.

Intervention Type DEVICE

Other Intervention Names

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FreeStyle Libre iCGM

Eligibility Criteria

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Inclusion Criteria

* Presence of Type 1 diabetes.
* Age \>18 years.
* Patients previously followed in the DIACAM study.

Exclusion Criteria

* Any other kinds of diabetes.
Minimum Eligible Age

16 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Castilla-La Mancha Health Service

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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La Mancha- Centro Hospital

Alcázar de San Juan, Ciudad Real, Spain

Site Status

Santa Barbara Hospital

Puertollano, Ciudad Real, Spain

Site Status

Virgen de Altagracia Hospital

Valdepeñas, Ciudad Real, Spain

Site Status

Virgen del Prado Hospital

Talavera de la Reina, Toledo, Spain

Site Status

Albacete University Hospital

Albacete, , Spain

Site Status

Obispo Rafael Torija, St.

Ciudad Real, , Spain

Site Status

Guadalajara University Hospital

Guadalajara, , Spain

Site Status

Toledo University Hospital

Toledo, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 23039989 (View on PubMed)

Moreno-Fernandez J, Sastre J, Pines P, Calderon-Vicente D, Gargallo J, Munoz-Rodriguez JR. To evaluate the use and clinical effect of intermittently scanned continuous glucose monitoring in adults with type 1 diabetes: Results of a multicentre study. Endocrinol Diabetes Nutr (Engl Ed). 2023 Apr;70(4):270-276. doi: 10.1016/j.endien.2023.03.013.

Reference Type DERIVED
PMID: 37116972 (View on PubMed)

Other Identifiers

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C-455

Identifier Type: -

Identifier Source: org_study_id

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