Prospective observational study to analyse the clinical effectiveness of a diabetes educational program to improve intermittently continuous glucose monitoring (iCGM) adherence in adult type 1 diabetes (T1D) patients
Cross-sectional prospective analysis of clinical efectiveness of a diabetes educational program to improve intermittently continuous glucose monitoring (iCGM) adherence in adult type 1 diabetes (T1D) patients. Glycometric data obtained through deidentified downloads from isCGM´s webpage. Primary outcome was time in range (TIR) 3.0-10 mmol/L (70-180 mg/d) change after the heatwave. Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are presented as mean ± SD values or percentages. A paired Student's t-test or a Wilcoxon signed-rank test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. A P value \< 0.05 was considered statistically significant. The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee (C-558).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
30-minute long diabetes educational program
Ciudad Real General University Hospital
Ciudad Real, Spain
Adherence to Flash 1
Number of intermittently scanned continuous glucose monitoring daily scanning (number of scans per day)
Time frame: 14 days
Time in range
Time in range (TIR) 3.0-10 mmol/L (70-180 mg/d) of interstitial glucose
Time frame: 14 days
Adherence to Flash 2
Time of use of intermittently scanned continuous glucose monitoring (% possible time of use)
Time frame: 14 days
Time below range 1 (TBR1)
Time bellow range \<3.9 mmol/L (\<70 mg/dL) of the interstitial glucose
Time frame: 14 days
Time below range 2 (TBR2)
Time bellow range \<3 mmol/L (\<54 mg/dL) of the interstitial glucose
Time frame: 14 days
Time above range 1 (TAR1)
Time above range \>10 mmol/L(\>180 mg/dL) of the interstitial glucose
Time frame: 14 days
Time above range 2 (TAR2)
Time above range \>13.9 mmol/L (\>250 mg/dL) of the interstitial glucose
Time frame: 14 days
Coefficient of variation percentage (CV)
Coefficient of variation percentage of interstitial glucose
Time frame: 14 days
Glucose management index
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Glucose management index of interstitial glucose
Time frame: 14 days
Time in hypoglycemia
Daily time in hypoglycemia (\<3.9 mmol/L, \<70 mg/dL) of interstitical glucose
Time frame: 14 days
Hypoglycemia frequency
Number of daily hypoglycemic events (\<3.9 mmol/L, \<70 mg/dL) of interstitical glucose
Time frame: 14 days
Percentage of patients attaining the the International Consensus on Time in Range (ICTR)
Percentage of patients (from total) attaining TIR\>70%, TBR1\<4%, TBR2\<1%, TAR1\<25%, TAR2\<5% and CV \<36%
Time frame: 14 days