Type 1 Diabetes
Conditions
Keywords
Diabetes, Type 1 diabetes
Brief summary
Observational study about effect of the greatest Spanish heatwave over glycemic contro in adult patients with type 1 Diabetes mellitus.
Detailed description
Cross-sectional retrospective analysis of all patients with T1D in Castilla-La Mancha (south-central Spanish region) using intermittently scanned continuous glucose monitoring (isCGM). 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.
Interventions
Use of Intermittenly scanned continuous glucose monitoring (FreeStyle Libre)
Sponsors
Castilla-La Mancha Health Service
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes * Older than 18 years old * Using intermittently scanned continuous glucose monitoring (isCGM) * Paired active isCGM data from the heatwave period and two consecutive weeks
Exclusion criteria
* Younger than 18 years old * Not using intermittently scanned continuous glucose monitoring * Not having active paired isCGM data from the analyzed periods
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Time in range | 14 days | Change in Time in range (TIR) 3.0-10 mmol/L (70-180 mg/d) of interstitial glucose from the heatwave period to 14 days after its end |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Adherence to Flash 1 | 14 days | Change in Time of use of intermittently scanned continuous glucose monitoring (% possible time of use) from the heatwave period to 14 days after its end |
| Change in Adherence to Flash 2 | 14 days | Change in Number of intermittently scanned continuous glucose monitoring daily scanning (number of scans/day) from the heatwave period to 14 days after its end |
| Change in Time below range 1 (TBR1) | 14 days | Change in Time bellow range \<3.9 mmol/L (\<70 mg/dL) of the interstitial glucose from the heatwave period to 14 days after its endfrom the heatwave period to 14 days after its end |
| Change in Time below range 2 (TBR2) | 14 days | Change in Time bellow range \<3 mmol/L (\<54 mg/dL) of the interstitial glucose from the heatwave period to 14 days after its end |
| Change in Time above range 1 (TAR1) | 14 days | Change in Time above range \>10 mmol/L(\>180 mg/dL) of the interstitial glucose from the heatwave period to 14 days after its end |
| Change in Coefficient of variation percentage (CV) | 14 days | Change in Coefficient of variation percentage of interstitial glucose from the heatwave period to 14 days after its end |
| Change in Glucose management index | 14 days | Change in Glucose management index of interstitial glucose from the heatwave period to 14 days after its end |
| Change in Time in hypoglycemia | 14 days | Change in Daily time in hypoglycemia (\<3.9 mmol/L, \<70 mg/dL) of interstitical glucose from the heatwave period to 14 days after its end |
| Change in Hypoglycemia frequency | 14 days | Change in Number of daily hypoglycemic events (\<3.9 mmol/L, \<70 mg/dL) of interstitical glucose from the heatwave period to 14 days after its end |
| Change in Time above range 2 (TAR2) | 14 days | Change in Time above range \>13.9 mmol/L (\>250 mg/dL) of the interstitial glucose from the heatwave period to 14 days after its end |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Percentage of patients attaining the the International Consensus on Time in Range (ICTR) goals | 14 days | Change in Percentage of patients (from total) attaining TIR\>70%, TBR1\<4%, TBR2\<1%, TAR1\<25%, TAR2\<5% and CV \<36% from the heatwave period to 14 days after its end |
Countries
Spain
Outcome results
None listed