Clinical Effects of Intermitent Continuous Glucose Monitoring in Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Clinical Effects of Intermitent Continuous Glucose Monitoring (Flash) in Adult Patients With Type 1 Diabetes in an Spanish Public Health System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05095610
• Other study ID #: C-455
• Status: Completed
• Start date: November 1, 2021
• Est. completion date: May 6, 2022

Study information

• Verified date: July 2022
• Source: Castilla-La Mancha Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1121
• Est. completion date: May 6, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 99 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Any other kinds of diabetes.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Spain	Albacete University Hospital	Albacete
Spain	La Mancha- Centro Hospital	Alcázar De San Juan	Ciudad Real
Spain	Obispo Rafael Torija, St.	Ciudad Real
Spain	Guadalajara University Hospital	Guadalajara
Spain	Santa Barbara Hospital	Puertollano	Ciudad Real
Spain	Virgen del Prado Hospital	Talavera De La Reina	Toledo
Spain	Toledo University Hospital	Toledo
Spain	Virgen de Altagracia Hospital	Valdepeñas	Ciudad Real

Sponsors (1)

Lead Sponsor	Collaborator
Castilla-La Mancha Health Service

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c difference	Difference in HbA1c before initiating iCGM compared with HbA1c levels after one year of treatment.	1 year
Secondary	Frequency of SBGM	Daily number of blood capilary test fot glycemia determination.	1 year
Secondary	Adherence to Flash	Time of use of Flash glucose monitoring (% possible time of use)	1 year
Secondary	TIR	Time in range (TIR, 3.9-10 mmol/L) of the interstitial glucose	1 year
Secondary	TAR	Time above range (TAR, >10 mmol/L) of the interstitial glucose	1 year
Secondary	TBR	Time bellow range (TBR, <3.9 mmol/L) of the interstitial glucose	1 year
Secondary	%CV	Percentage of the variation coefficient (%, >36% is considered high levels)	1 year
Secondary	Body weight	Total corporal body weight (Kg)	1 year
Secondary	Insulin dose	Daily insulin dose requirements (UI/Kg/d)	1 year