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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flash | Device | Use of the device FreeStyle Libre, only commercialized system for intermitent continuous glucose monitoring. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c difference | Difference in HbA1c before initiating iCGM compared with HbA1c levels after one year of treatment. | 1 year |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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All patients >18 years with type 1 diabetes and previously followed in the DIACAM study (see reference).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Mancha- Centro Hospital | Alcázar de San Juan | Ciudad Real | 13600 | Spain | ||
| Santa Barbara Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23039989 | Background | 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. | |
| 37116972 |
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After approval for the rest ot investigators.
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| C000726607 | photopsia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |
| Puertollano |
| Ciudad Real |
| 13500 |
| Spain |
| Virgen de Altagracia Hospital | Valdepeñas | Ciudad Real | 13300 | Spain |
| Virgen del Prado Hospital | Talavera de la Reina | Toledo | 45600 | Spain |
| Albacete University Hospital | Albacete | 02006 | Spain |
| Obispo Rafael Torija, St. | Ciudad Real | 13005 | Spain |
| Guadalajara University Hospital | Guadalajara | 19002 | Spain |
| Toledo University Hospital | Toledo | 45007 | Spain |
| Derived |
| 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. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |