Effect of Heatwaves on Glycemic Control in People With Type 1 Diabetes Treated With Artificial Pancreas

Castilla-La Mancha Health Service193 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

193

Conditions

Type 1 Diabetes

Interventions

advanced hybrid closed-loopDEVICE

An advanced hybrid closed-loop system is a type of insulin delivery system that uses an algorithm to automatically adjust insulin delivery based on glucose levels. It combines an insulin pump with a continuous glucose monitor (CGM) and uses a closed-loop algorithm to adjust insulin doses based on real-time glucose readings. The "hybrid" aspect refers to the fact that the system still requires some user input, such as entering meal information, but the algorithm takes over the majority of insulin dosing decisions.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (9)

La Mancha-Centro Hospital

Alcázar de San Juan, Ciudad Real, Spain

Santa Barbara Hospital

Puertollano, Ciudad Real, Spain

Valdepeñas General Hospital

Valdepeñas, Ciudad Real, Spain

Virgen del Prado Hospital

Talavera de la Reina, Toledo, Spain

Outcomes

Primary Outcomes

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 heatwaves period to 14 days after its end

Time frame: 14 days

Secondary Outcomes

Adherence to advaced hybrid closed-loop

Change in Time of use automatization of advanced hybrid closed-loop (% possible time of use) from the heatwaves period to 14 days after its end

Time frame: 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 heatwaves period to 14 days after its endfrom the heatwave period to 14 days after its end

Time frame: 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 heatwaves period to 14 days after its end

Time frame: 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 heatwaves period to 14 days after its end

Time frame: 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 heatwaves period to 14 days after its end

Time frame: 14 days

Change in Coefficient of variation percentage (CV)

Change in Coefficient of variation percentage of interstitial glucose from the heatwaves period to 14 days after its end

Data from ClinicalTrials.gov

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