Effect of Heatwave Over Glycemic Control in Patients With T1D

Type 1 Diabetes Clinical Trial

Official title:

Effect of the Greatest Spanish Heatwave Over Glycemic Control in Adult Patients With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05646017
• Other study ID #: C-566
• Status: Completed
• Start date: December 15, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2023
• Source: Castilla-La Mancha Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observational study about effect of the greatest Spanish heatwave over glycemic contro in adult patients with type 1 Diabetes mellitus.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2701
• Est. completion date: January 31, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• Intermittenly scanned continuous glucose monitoring
Use of Intermittenly scanned continuous glucose monitoring (FreeStyle Libre)

Locations

Country	Name	City	State
Spain	Albacete University Hospital	Albacete
Spain	La Mancha-Centro Hospital	Alcázar De San Juan	Ciudad Real
Spain	Ciudad Real General University Hospital	Ciudad Real
Spain	Virgen de la Luz University Hospital	Cuenca
Spain	Guadalajara University Hospital	Guadalajara
Spain	Santa Barbara Hospital	Puertollano	Ciudad Real
Spain	Virgen del Prado Hospital	Talavera De La Reina	Toledo
Spain	Toledo University Hospital	Toledo
Spain	Valdepeñas General Hospital	Valdepeñas	Ciudad Real

Sponsors (1)

Lead Sponsor	Collaborator
Castilla-La Mancha Health Service

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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, Kor — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Secondary	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
Secondary	Change in Adherence to Flash 2	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Spanish National Weather Agency