Clinical Effects of Intermitent Continuous Glucose Monitoring in Type 1 Diabetes

Completed

• Conditions: Type 1 Diabetes
• Interventions: Device: Flash

• Registration Number: NCT05095610
• Lead Sponsor: Castilla-La Mancha Health Service

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.

Study Timeline

• Study First Submitted: 2021-09-30
• Study First Submitted QC: 2021-10-15
• Study First Posted: 2021-10-27
• Study Start: 2021-11-01
• Primary Completion: 2022-03-30
• Study Completion: 2022-05-06
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1121

Inclusion Criteria

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

Exclusion Criteria

• Any other kinds of diabetes.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult Type 1 Diabetes	Flash	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.

Primary Outcome Measures

Name	Time	Method
HbA1c difference	1 year	Difference in HbA1c before initiating iCGM compared with HbA1c levels after one year of treatment.

Secondary Outcome Measures

Name	Time	Method
Insulin dose	1 year	Daily insulin dose requirements (UI/Kg/d)
TBR	1 year	Time bellow range (TBR, \<3.9 mmol/L) of the interstitial glucose
TAR	1 year	Time above range (TAR, \>10 mmol/L) of the interstitial glucose
%CV	1 year	Percentage of the variation coefficient (%, \>36% is considered high levels)
Body weight	1 year	Total corporal body weight (Kg)
Frequency of SBGM	1 year	Daily number of blood capilary test fot glycemia determination.
TIR	1 year	Time in range (TIR, 3.9-10 mmol/L) of the interstitial glucose
Adherence to Flash	1 year	Time of use of Flash glucose monitoring (% possible time of use)

Trial Locations

Locations (8)

Santa Barbara Hospital; 🇪🇸 Puertollano, Ciudad Real, Spain

Virgen del Prado Hospital; 🇪🇸 Talavera De La Reina, Toledo, Spain

Albacete University Hospital; 🇪🇸 Albacete, Spain

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

Guadalajara University Hospital; 🇪🇸 Guadalajara, Spain

Toledo University Hospital; 🇪🇸 Toledo, Spain

La Mancha- Centro Hospital; 🇪🇸 Alcázar De San Juan, Ciudad Real, Spain

Virgen de Altagracia Hospital; 🇪🇸 Valdepeñas, Ciudad Real, Spain