Effect of Heatwave Over Glycemic Control in Patients With T1D
Study Details
Study Description
Brief Summary
Observational study about effect of the greatest Spanish heatwave over glycemic contro in adult patients with type 1 Diabetes mellitus.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Type 1 diabetes patients Type 1 diabetes patients using intermittently continuous glucose monitoring during the Spanish greatest heatwave in Castilla-La Mancha (Spain). |
Device: Intermittenly scanned continuous glucose monitoring
Use of Intermittenly scanned continuous glucose monitoring (FreeStyle Libre)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 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
- 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
Other Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Type 1 diabetes
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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
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Not having active paired isCGM data from the analyzed periods
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | La Mancha-Centro Hospital | Alcázar De San Juan | Ciudad Real | Spain | 13600 |
| 2 | Santa Barbara Hospital | Puertollano | Ciudad Real | Spain | 13500 |
| 3 | Valdepeñas General Hospital | Valdepeñas | Ciudad Real | Spain | 13300 |
| 4 | Virgen del Prado Hospital | Talavera De La Reina | Toledo | Spain | 45600 |
| 5 | Albacete University Hospital | Albacete | Spain | 02006 | |
| 6 | Ciudad Real General University Hospital | Ciudad Real | Spain | 13005 | |
| 7 | Virgen de la Luz University Hospital | Cuenca | Spain | 16002 | |
| 8 | Guadalajara University Hospital | Guadalajara | Spain | 19002 | |
| 9 | Toledo University Hospital | Toledo | Spain | 45007 |
Sponsors and Collaborators
- Castilla-La Mancha Health Service
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Moon J. The effect of the heatwave on the morbidity and mortality of diabetes patients; a meta-analysis for the era of the climate crisis. Environ Res. 2021 Apr;195:110762. doi: 10.1016/j.envres.2021.110762. Epub 2021 Jan 27.
- Song X, Jiang L, Zhang D, Wang X, Ma Y, Hu Y, Tang J, Li X, Huang W, Meng Y, Shi A, Feng Y, Zhang Y. Impact of short-term exposure to extreme temperatures on diabetes mellitus morbidity and mortality? A systematic review and meta-analysis. Environ Sci Pollut Res Int. 2021 Nov;28(41):58035-58049. doi: 10.1007/s11356-021-14568-0. Epub 2021 Jun 8.
- Xu Z, Tong S, Cheng J, Crooks JL, Xiang H, Li X, Huang C, Hu W. Heatwaves and diabetes in Brisbane, Australia: a population-based retrospective cohort study. Int J Epidemiol. 2019 Aug 1;48(4):1091-1100. doi: 10.1093/ije/dyz048.
- C-566