NCT06214780

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

Effect of Heatwaves on Glycemic Control in Adult Patients With Type 1 Diabetes Mellitus Treated With Advanced Hybrid Closed Loop Systems

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 193 (actual)
• Sponsor: Castilla-La Mancha Health Service · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: —

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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	advanced hybrid closed-loop	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.

Timeline

• Start date: 2024-01-22
• Primary completion: 2024-04-30
• Completion: 2024-05-31
• First posted: 2024-01-22
• Last updated: 2024-08-22

Locations

9 sites across 1 country: Spain