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Observational study about effect of the greatest Spanish heatwave over glycemic contro in adult patients with type 1 Diabetes mellitus.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 1 diabetes patients | Type 1 diabetes patients using intermittently continuous glucose monitoring during the Spanish greatest heatwave in Castilla-La Mancha (Spain). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittenly scanned continuous glucose monitoring | Device | Use of Intermittenly scanned continuous glucose monitoring (FreeStyle Libre) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Time in range | 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 | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Adherence to Flash 1 | 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 | 14 days |
| Change in Adherence to Flash 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percentage of patients attaining the the International Consensus on Time in Range (ICTR) goals | 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 | 14 days |
Inclusion Criteria:
Exclusion Criteria:
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Adult type 1 diabetes patients using intermittently scanned continuous glucose monitoring during and after the greatest Spanish heatwave.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Mancha-Centro Hospital | Alcázar de San Juan | Ciudad Real | 13600 | Spain | ||
| Santa Barbara Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34105073 | Background | 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. | |
| 33515577 |
| Label | URL |
|---|---|
| Spanish National Weather Agency | View source |
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Under other researchers request.
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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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
| 14 days |
| Change in Time below range 1 (TBR1) | 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 | 14 days |
| Change in Time below range 2 (TBR2) | 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 | 14 days |
| Change in Time above range 1 (TAR1) | 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 | 14 days |
| Change in Time above range 2 (TAR2) | 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 | 14 days |
| Change in Coefficient of variation percentage (CV) | Change in Coefficient of variation percentage of interstitial glucose from the heatwave period to 14 days after its end | 14 days |
| Change in Glucose management index | Change in Glucose management index of interstitial glucose from the heatwave period to 14 days after its end | 14 days |
| Change in Time in hypoglycemia | 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 | 14 days |
| Change in Hypoglycemia frequency | 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 | 14 days |
| Puertollano |
| Ciudad Real |
| 13500 |
| Spain |
| Valdepeñas General Hospital | Valdepeñas | Ciudad Real | 13300 | Spain |
| Virgen del Prado Hospital | Talavera de la Reina | Toledo | 45600 | Spain |
| Albacete University Hospital | Albacete | 02006 | Spain |
| Ciudad Real General University Hospital | Ciudad Real | 13005 | Spain |
| Virgen de la Luz University Hospital | Cuenca | 16002 | Spain |
| Guadalajara University Hospital | Guadalajara | 19002 | Spain |
| Toledo University Hospital | Toledo | 45007 | Spain |
| 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. |
| 30927429 | Background | 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. |
| 31177185 | Result | Battelino T, Danne T, Bergenstal RM, Amiel SA, Beck R, Biester T, Bosi E, Buckingham BA, Cefalu WT, Close KL, Cobelli C, Dassau E, DeVries JH, Donaghue KC, Dovc K, Doyle FJ 3rd, Garg S, Grunberger G, Heller S, Heinemann L, Hirsch IB, Hovorka R, Jia W, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Levine B, Mayorov A, Mathieu C, Murphy HR, Nimri R, Norgaard K, Parkin CG, Renard E, Rodbard D, Saboo B, Schatz D, Stoner K, Urakami T, Weinzimer SA, Phillip M. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care. 2019 Aug;42(8):1593-1603. doi: 10.2337/dci19-0028. Epub 2019 Jun 8. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |