Clinical trial NCT05095610: Clinical Effects of Intermitent Continuous Glucose Monitoring in Type 1 Diabetes
Official title: Clinical Effects of Intermitent Continuous Glucose Monitoring (Flash) in Adult Patients With Type 1 Diabetes in an Spanish Public Health System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes
intermitent continous glucose monitoring
Flash
Lead sponsor: Castilla-La Mancha Health Service
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 1121
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients \>18 years with type 1 diabetes and previously followed in the DIACAM study (see reference).

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Any other kinds of diabetes.

Primary outcomes:
measure: HbA1c difference
timeFrame: 1 year
Secondary outcomes:
measure: Frequency of SBGM
timeFrame: 1 year
measure: Adherence to Flash
timeFrame: 1 year
measure: TIR
timeFrame: 1 year
measure: TAR
timeFrame: 1 year
measure: TBR
timeFrame: 1 year
measure: %CV
timeFrame: 1 year
measure: Body weight
timeFrame: 1 year
measure: Insulin dose
timeFrame: 1 year
Other outcomes:
Locations:
city: Alcázar De San Juan
country: Spain
facility: La Mancha- Centro Hospital
state: Ciudad Real
city: Puertollano
country: Spain
facility: Santa Barbara Hospital
state: Ciudad Real
city: Valdepeñas
country: Spain
facility: Virgen de Altagracia Hospital
state: Ciudad Real
city: Talavera De La Reina
country: Spain
facility: Virgen del Prado Hospital
state: Toledo
city: Albacete
country: Spain
facility: Albacete University Hospital
city: Ciudad Real
country: Spain
facility: Obispo Rafael Torija, St.
city: Guadalajara
country: Spain
facility: Guadalajara University Hospital
city: Toledo
country: Spain
facility: Toledo University Hospital
Study officials:
References:
citation: 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.