Clinical trial NCT06214780: Effect of Heatwaves on Glycemic Control in People With Type 1 Diabetes Treated With Artificial Pancreas
Official title: Effect of Heatwaves on Glycemic Control in Adult Patients With Type 1 Diabetes Mellitus Treated With Advanced Hybrid Closed Loop Systems
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: advanced hybrid closed-loop
artificial pancreas
heatwave
climate change
global warming
Lead sponsor: Castilla-La Mancha Health Service
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult type 1 diabetes patients using AHCL during and after heatwaves in Castilla-La Mancha (Spain).

Brief summary: To analyze the effect of heatwaves on interstitial glucose in adult patients with type 1 diabetes mellitus treated with artificial pancreas

Detailed description: Observational retrospective study to analyze the effect of heatwaves on interstitial glucose in adult patients with type 1 diabetes mellitus treated with advanced hybrid closed-loop systems in the Castilla-La Mancha region (southcentral Spain). Main objective is the difference in time in range of intersticial glucose between 3.0-10 mmol/L (70-180 mg/d) measured throught real-time continuous glucose monitoring during the two consecutive greatest heatwave during summer 2024 (5th-26th August) comparted to the following period (27th August to 17th September). 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 advanced hybrid closed-loop systems (AHCL)
* Paired active AHCL data from the heatwave periods and two consecutive weeks

Exclusion Criteria:

* Younger than 18 years old
* Not using AHCL
* Not having active paired AHCL data from the analyzed periods

Primary outcomes:
measure: Change in time in range
timeFrame: 14 days
Secondary outcomes:
measure: Adherence to advaced hybrid closed-loop
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 Percentage of patients attaining the the International Consensus on Time in Range (ICTR) goals
timeFrame: 14 days
measure: Change in Percentage of time of varibles modes of automatization
timeFrame: 14 days
Other outcomes:
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: 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.
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: Moreno-Fernandez J, Sastre J, Herranz S, Pines P, Gomez FJ, Quiroga I, Moya AJ, Gonzalvo C, Miralles R, Calderon-Vicente D, Palma M, Gargallo J, Munoz-Rodriguez JR. Effect of the historic Spanish heatwave over glycemic control in adult patients with type 1 diabetes. Sci Total Environ. 2023 Sep 1;889:164045. doi: 10.1016/j.scitotenv.2023.164045. Epub 2023 May 17.