Type 1 Diabetes
Conditions
Keywords
type 1 diabetes, intermitent continous glucose monitoring, Flash
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.
Interventions
DEVICEFlash
Use of the device FreeStyle Libre, only commercialized system for intermitent continuous glucose monitoring.
Sponsors
Castilla-La Mancha Health Service
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
16 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Presence of Type 1 diabetes. * Age \>18 years. * Patients previously followed in the DIACAM study.
Exclusion criteria
* Any other kinds of diabetes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c difference | 1 year | Difference in HbA1c before initiating iCGM compared with HbA1c levels after one year of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| %CV | 1 year | Percentage of the variation coefficient (%, \>36% is considered high levels) |
| Body weight | 1 year | Total corporal body weight (Kg) |
| 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 |
| TIR | 1 year | Time in range (TIR, 3.9-10 mmol/L) of the interstitial glucose |
| TAR | 1 year | Time above range (TAR, \>10 mmol/L) of the interstitial glucose |
| Frequency of SBGM | 1 year | Daily number of blood capilary test fot glycemia determination. |
| Adherence to Flash | 1 year | Time of use of Flash glucose monitoring (% possible time of use) |
Countries
Spain
Outcome results
None listed