Type 1 Diabetes
Conditions
Brief summary
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
Detailed description
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).
Interventions
OTHERDiabetes educational program
30-minute long diabetes educational program
Sponsors
Castilla-La Mancha Health Service
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
30 minutes diabetes educational program: * 10-minute talk about Flash measurements and importance of diabetes control. * 10-minute practic exercises with Flash values and tendencies. * 10-minute talk about recomendations for increasing daily Flash scanning.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes * Flash user for at least 6 months. * Treatment with multiple daily insulin injections (MDI). * Daily scan Flash frequency 4 or less
Exclusion criteria
* Other types of diabetes * Other types of diabetes treatment different from MDI (pe insulin pump)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Flash 1 | 14 days | Number of intermittently scanned continuous glucose monitoring daily scanning (number of scans per day) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Flash 2 | 14 days | Time of use of intermittently scanned continuous glucose monitoring (% possible time of use) |
| Time below range 1 (TBR1) | 14 days | Time bellow range \<3.9 mmol/L (\<70 mg/dL) of the interstitial glucose |
| Time below range 2 (TBR2) | 14 days | Time bellow range \<3 mmol/L (\<54 mg/dL) of the interstitial glucose |
| Time above range 1 (TAR1) | 14 days | Time above range \>10 mmol/L(\>180 mg/dL) of the interstitial glucose |
| Time above range 2 (TAR2) | 14 days | Time above range \>13.9 mmol/L (\>250 mg/dL) of the interstitial glucose |
| Time in range | 14 days | Time in range (TIR) 3.0-10 mmol/L (70-180 mg/d) of interstitial glucose |
| Glucose management index | 14 days | Glucose management index of interstitial glucose |
| Time in hypoglycemia | 14 days | Daily time in hypoglycemia (\<3.9 mmol/L, \<70 mg/dL) of interstitical glucose |
| Hypoglycemia frequency | 14 days | Number of daily hypoglycemic events (\<3.9 mmol/L, \<70 mg/dL) of interstitical glucose |
| Percentage of patients attaining the the International Consensus on Time in Range (ICTR) | 14 days | Percentage of patients (from total) attaining TIR\>70%, TBR1\<4%, TBR2\<1%, TAR1\<25%, TAR2\<5% and CV \<36% |
| Coefficient of variation percentage (CV) | 14 days | Coefficient of variation percentage of interstitial glucose |
Countries
Spain
Outcome results
None listed