Clinical Effects of Intermitent Continuous Glucose Monitoring in Type 1 Diabetes

Study Overview
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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.

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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: Flash


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult Type 1 Diabetes<br>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. | Device: Flash<br>* Use of the device FreeStyle Libre, only commercialized system for intermitent continuous glucose monitoring.<br>* Other names: iCGM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c difference | Difference in HbA1c before initiating iCGM compared with HbA1c levels after one year of treatment. | 1 year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 1 diabetes, intermitent continous glucose monitoring, Flash