Clinical trial NCT05646017: Effect of Heatwave Over Glycemic Control in Patients With T1D
Official title: Effect of the Greatest Spanish Heatwave Over Glycemic Control in Adult Patients With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: Diabetes
Type 1 diabetes
Lead sponsor: Castilla-La Mancha Health Service
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 2701
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult type 1 diabetes patients using intermittently scanned continuous glucose monitoring during and after the greatest Spanish heatwave.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Time in range
timeFrame: 14 days
Secondary outcomes:
measure: Change in Adherence to Flash 1
timeFrame: 14 days
measure: Change in Adherence to Flash 2
timeFrame: 14 days
measure: Change in Time below range 1 (TBR1)
timeFrame: 14 days
measure: Change in Time below range 2 (TBR2)
timeFrame: 14 days
measure: Change in Time above range 1 (TAR1)
timeFrame: 14 days
measure: Change in Time above range 2 (TAR2)
timeFrame: 14 days
measure: Change in Coefficient of variation percentage (CV)
timeFrame: 14 days
measure: Change in Glucose management index
timeFrame: 14 days
measure: Change in Time in hypoglycemia
timeFrame: 14 days
measure: Change in Hypoglycemia frequency
timeFrame: 14 days
Other outcomes:
measure: Change in Percentage of patients attaining the the International Consensus on Time in Range (ICTR) goals
timeFrame: 14 days
Locations:
city: Alcázar De San Juan
country: Spain
facility: La Mancha-Centro Hospital
state: Ciudad Real
city: Puertollano
country: Spain
facility: Santa Barbara Hospital
state: Ciudad Real
city: Valdepeñas
country: Spain
facility: Valdepeñas General Hospital
state: Ciudad Real
city: Talavera De La Reina
country: Spain
facility: Virgen del Prado Hospital
state: Toledo
city: Albacete
country: Spain
facility: Albacete University Hospital
city: Ciudad Real
country: Spain
facility: Ciudad Real General University Hospital
city: Cuenca
country: Spain
facility: Virgen de la Luz University Hospital
city: Guadalajara
country: Spain
facility: Guadalajara University Hospital
city: Toledo
country: Spain
facility: Toledo University Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.