Effect of Heatwaves on Glycemic Control in People With Type 1 Diabetes Treated With Artificial Pancreas (HEAT1)

Castilla-La Mancha Health Service

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Device: advanced hybrid closed-loop

Study type: Observational

Funder types: Other

Identifiers

NCT06214780

CI

Details and patient eligibility

About

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

Full 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.

Enrollment: 193 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

193 participants in 1 patient group

Type 1 diabetes patients

Description:

Adult patients treated with advanced hybrid closed-loop in Castilla-La Mancha during summer 2023.

Treatment:

Device: advanced hybrid closed-loop